Emancipation Day A Reminder That Caribbean Still Needs Justice, Repair – Human Rights Watch

On August 1, Anglophone Caribbean nations commemorateEmancipation Day, marking the 1834 abolition of slavery in the British Empire and the 1838 abolition ofapprenticeship, a system which forced formerly enslaved people to continue to work uncompensated for their former masters. Emancipation wasnot a gift. The Slavery Abolition Act, which banned slavery in the British colonies, followed a shift in the British Empires economic interests and sustained resistance by enslaved people through massive slave revolts, likeBussas Rebellionin Barbados, andguerilla warfare, as in the case ofJamaicas Maroons.

While resistance helped pave the way for emancipation in the 1800s, the Caribbean was not free from British colonial rulefor another century. For centuries, Caribbean people fought for liberation from slavery and colonization. Today, amid new calls for the UK to tackle systemic racism and reckon with the crimes of the British Empire, Caribbean people are still fighting for justice and repair.

On July 6, the Caribbean Community (CARICOM) Reparations Commissionreignited calls for reparationsfor slavery and colonization, emphasizing the impact of the legacy of British colonialism on life and legislation in the Caribbean today. The Commission, established in 2013 to prepare the legal and ethical case for reparations payments for CARICOM member states, lays out a 10 point plan for European former colonial powers to provide reparatory justice for slavery and colonization. The first step in the Commissions plan is a formal apology for slavery. To date, the UK has expressed deep regret for its role in the Trans-Atlantic Slave Trade, but has never formally apologized. A full apology is an important step, not only for atonement, but also because it is an opportunity to acknowledge and examine the contemporary effects of the British Empires abusive practices in the Caribbean.

British slave traders kidnapped an estimated3.1 million peoplealong the west coast of Africa,trafficked them across the Atlantic Ocean, and subjected them toforced labor and tortureon the colonialplantationsthatenriched the British crown. British colonial legislation codified racial difference between the white planter class and enslaved Africans, and regulated slaves behavior through harsh slave codes. Slaves were denied access to land, education, or any means of social and economic advancement. CARICOM Reparations Committee chair Professor Hilary Beckles has noted how severe neglect by British colonial authorities of the human development of Black populations in the Caribbean led to rampant illiteracy and serious health issues across the region, which continued after emancipation.

Black populations in the Caribbean were also denied political and economic autonomy. Under British colonial law (as in the United Kingdom until the early twentieth century), the right to vote was predicated on a mans wealth and land ownership. In the Caribbean this effectively excluded the poorer, landless Black majority from voting for more than a century after emancipation. Without the right to vote in elections, Black populations were subjected to the legislative whims of the white upper classes and denied representation in government without the ability to hold political authorities accountable. Universal Adult Suffrage in the Caribbean was not achieved until 1944, first in Jamaica, and then spreading to other Caribbean islands between then and 1962.

Colonial legislation safeguarding the wealth of the white British planter class, through the control and violent exploitation of Black African labor, cemented the deep racial and economic inequality that persists across the Caribbean today. In Barbados, for example, formerly enslaved people and their descendants were excluded from purchasing land under the colonial Contract Law. The effects of the law continued after independence and by 1970, an estimated 77% of land in Barbados rested in the hands of the wealthiest 10% of the countrys landowners.

Some British firms that were enriched by the Trans-Atlantic slave trade have apologized, and some, like insurance company Lloyds of London, have agreed to make financial contributions to organizations supporting Black and ethnic minority communities. The British government, however, has previously dismissed and derailed calls for reparations for slavery and colonization. In 2001, the British delegation to the Durban Conference on Racism, Racial Discrimination, Xenophobia and Related Intolerance blocked an outright apology for slavery by the European Union, despite support for the apology from some other European delegates.

During a 2015 visit to Jamaica, former UK Prime Minister David Cameron rebuffedcalls by the Jamaica National Commission on Reparationsfor the UK to pay Jamaica reparations, stating the country should move on. Instead of reparations, Cameron announced that the UK would spend25million pounds to build Jamaica a new prison. Camerons offer was particularly pernicious considering the history ofunlawful detentionandexcessive use of force by the Jamaica Constabulary Force, which isheavily influencedby colonial lawsdesigned to enforcea racist and exploitative colonial social order.

The British empires brutal trafficking and abuse of enslaved Africans throughout the Caribbean, and the continued exploitation of their descendants during colonialism, helped form thebasis for the mercantile wealth that built modern British society. Despite this, Caribbean people have been routinely denied remedy for past injustices, and continue to feel the effects of colonization as well assuffer abuses at the hands of the British government in the United Kingdom today.

As we commemorate the end of slavery in the Caribbean, we must not forget that the region is still in need of justice and repair. If we are truly to move on, the British government should acknowledge the extent of abuses committed during slavery and colonization and begin the conversation on the contemporary ramifications of past harms by the British Empire.

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Emancipation Day A Reminder That Caribbean Still Needs Justice, Repair - Human Rights Watch

Blended Capital For Immigration Bonds: Introducing The Freedom100 Fund – Forbes

FFI staff & volunteers with friends from J.M. Kaplan Fund.

While finance to many might conjure a boring system of transactions or a dangerous game of capitalist exploitation to financial activists, investment vehicles are fair game for creative and exciting innovations toward liberation. One area of continuous advocacy is the abolition of bail, which forces countless individuals to remain in jail simply because they cannot afford their own release. Often, the over-incarcerated and their loved ones have to turn to bail bonds companies that exploit the vulnerability of their financial situations, charge exorbitant interest, and require collateral in exchange for the funds needed for bail. According to the Prison Policy Institute, over 465,000 people are held in local jails every day without being convicted of a crime, simply because they cant afford their bail.

Bail isnt just part of the criminal justice system you might be surprised to hear that it exists in the immigrant detention system, too. Except that in this context, its referred to as immigration bond. Thats right, take a second to wrap your head around this: despite committing what should be a civil, not criminal, infraction, immigrants who cross the border seeking a better life are asked to pay bond. Tens of thousands of children and adults are in this position on any given day, stuck in immigrant prisons and jails for years. With the costs of bonds ranging from $1,500 to $250,000, immigrants and their families often cannot afford to pay bond.

Numerous bail funds like the Bail Project, New Yorks Free Them All for Public Health, and LAs Peoples City Council Freedom Fund have historically helped address the criminalization of poverty in the U.S. and advocates have been working to end cash bail entirely. In the wake of mass arrests of protestors around the country in support of the Movement for Black Lives, many bail funds have experienced an unprecedented surge in financial support. But there has been less attention on immigrant detention. Thats where Freedom for Immigrants has stepped in. Since 2010, they have supported both bond funding and critical post-release wraparound services for immigrants nationwide. Their National Hotline, the nations largest for immigrants in detention, receives between 600 and 14,500 calls per month. They are part of a growing network of bail and immigration bond funds across the country, hosted by Community Justice Exchange.

Freedom for Immigrants is a national nonprofit that has grown from monitoring the human rights abuses faced by immigrants detained by ICE through their national hotline and network of volunteer detention visitors to also include actionable approaches for dignity, not detention. These approaches call for divestment from for-profit incarceration and investment in community-based organizations and tools like bond funds to welcome immigrants into the social fabric of the United States. The organization is now partnering with Mission Driven Finance an impact investment firm and certified B Corporation dedicated to using finance as a tool for change, expanding access to capital, and closing opportunity gaps to launch the Freedom100 Fund. This new pilot fund aims to release 100 individuals from immigration prison, support them with their cases and prove that its time for the bail and bond system to go.

I talked with Lauren Grattan, Co-Founder and Chief Community Officer of Mission Driven Finance, and Christina Mansfield, Co-Founder and Co-Executive Director of Freedom for Immigrants, to learn more about this bond fund, how it works, and why its an important development for investors and activists committed to immigrant freedom.

For those who may be new to this world, whats the current problem with immigration bonds and the criminalization of poverty in the United States that you're trying to address? How has COVID-19 added another layer to this?

Gretta Soto Moreno, member of FFI Leadership Council.

CM: On any given day, thousands of immigrants are locked up in prisons and jails as part of the U.S. immigration detention system. The system is composed largely of people who are either newly arrived, such as asylum seekers, or those individuals who have longstanding ties to their communities here in the U.S.

Individuals who flee their home countries to seek refuge in the U.S. and claim asylum at a port of entry have been subject to mandatory immigration detention since at least 1996 as a result of harsh policies signed into law by President Clinton. Those same laws expanded the list of aggravated felonies for which people like Legal Permanent Residents and others could be detained and made subject to deportation, including many non-violent offenses. Around that same time period, a series of tough on crime laws were passed that further criminalized communities of color. As a result, since 1996, there has been a dramatic increase in the number of people who have been sent to ICE detention.

Its also important to recognize that throughout this period of time the federal government has increased its use of criminal prosecutions for people migrating. The federal government considers illegal entry a misdemeanor while illegal re-entry is considered a felony. The family separation crisis grew out of these policies, forcing families to be split up needlessly and inhumanely.

COVID-19 has added another layer of complexity and urgency to the situation. Freedom for Immigrants and other partners are focused on helping to bond out people who are immunocompromised and medically vulnerable. We are also submitting parole requests for the release of people without paying cash bonds, but the federal government is only granting a small number of these requests. In addition, Freedom for Immigrants is tracking abuses related to the pandemic and the organized responses of people inside on this real-time map.

How did Freedom for Immigrants and Mission Driven Finance decide to collaborate on this new initiative, using money as a tool for social change rather than a weapon for exploitation?

LG: When we met Freedom for Immigrants and grasped the size and severity of the issue of immigrant detention, we knew we wanted to support their incredible work rehumanizing a cruel system. Immigration is part of our daily lives in our hometown of San Diego, where we have the most active land border crossing in the country and one in four San Diegans are born outside the U.S.

CM: At Freedom for Immigrants, we know human rights and immigration policy really well, but innovative finance is not our strength. It was critical to find our partners at Mission Driven Finance as they fully believe in our vision and worked within our ethical framework to co-create this fund expanding our national detention bond program.

LG: We partnered with Freedom for Immigrants to develop the Freedom100 Fund a first-of-its-kind opportunity to finance bonds and release 100 people from immigration detention across California and Louisiana at no cost to the individual. Once bonded out, individuals are eight times more likely to win their immigration cases. But without the ability to pay a bond, many individuals are forced to languish in immigration detention and away from their loved ones and communities and forced to navigate complex legal proceedings on their ownoften in a language that is not their first.

As more people have been detained and the costs of immigration bonds have skyrocketed (the median bond in California and Louisiana is $8,500), families and community groups that previously donated money to bond out their loved ones are now strapped for cash. This is a perfect space for impact investing: Amplifying limited philanthropic dollars.

CM: We chose California and Louisiana because they represent some of the best and worst jurisdictions for immigrants to win their cases, respectively. In Louisiana, 87.8% of all immigration detention cases are denied, whereas only 52.2% of cases in California are denied. By bonding out individuals in these two states, connecting them to supportive resources, and helping them make all their court appearances, we can demonstrate that the practice of detention isnt just inhumane and wildly subject to political bias its unnecessary.

So how does this fund actually work and what is the ultimate goal?

LG: The Freedom100 Fund is designed to extend the impact of donated dollars. In a nutshell, instead of making donations directly to post bonds, donors make grants into a reserve account that absorbs some of the risk to make the opportunity more attractive for private investors who might not have financed immigration bonds otherwise. The fund is structured to leverage $500,000 in the philanthropic reserve account at least four times, unlocking $2M of investor capital and ultimately expand the availability of rapid, free immigration bond financing.

The fund lends to Freedom for Immigrants to have the money to post bond directly at ICE field offices on behalf of 100 individuals. As individuals go to their immigration court appearances and get their cases resolved (positively or negatively), the Department of Homeland Security (DHS) repays Freedom for Immigrants which would then repay the fund.

We need every tool in the toolbox, including finance, to make a more just world. Our hope is that the Freedom100 Fund can provide dignity and care for 100 individuals immediately and hopefully scale to serve thousands. We also want the fund to serve as a model for how innovative finance can move the needle on some of our most difficult social and environmental challenges and quickly. The first capital from the fund flowed to Freedom For Immigrants earlier in July and theyve already bonded out eight individuals.

Why is this bond fund an impact investing fund instead of just a philanthropic effort?

LG: As an investment firm, we like to right-size the tool to the problem. Philanthropy makes a lot of sense for proving early on that a program can work, for subsidizing programs that dont have a functional market, and for taking on riskier financial positions to unlock other capital. But to fully address problems of this size, we have to mobilize more than just philanthropy.

Thanks to their donors, Freedom for Immigrants has built a successful detention bond program and critical case management support. And now donors are committing to that third scenario of unlocking other capital because they need more money in this fight than donations alone.

We always look for repayment pathways to see if impact investing is possible. As strange as it is, the fact that DHS repays bonds at the conclusion of immigration trials gave us the opportunity to explore an investment strategy with Freedom for Immigrants. Because of this fact, we were able to build this structure without burdening immigrants or their families, unlike most other bond financing. Its a highly unusual revenue source, but it is a revenue source!

If this system is so wrong how do we end it, as opposed to financing it? Clearly the Freedom100 Fund can help get people out of detention centers now a critical outcome but is it also enabling the system?

CM: This is a critical question we must continually ask ourselves as abolitionists. Freedom for Immigrants combines direct services to people in immigrant prisons and jails with policy and advocacy to end the system completely. When we decide on the scope of our work, we always ask ourselves whether what we are doing could lead to the perpetuation of the system. The Freedom100 Fund is a great example of this calculus.

Our goal of the fund is twofold:

1) Secure the freedom of 100 individuals currently incarcerated only because they cannot afford to pay a bond; and

2) Leverage the model to advocate that the incarceration of immigrants in our detention system is entirely unnecessary and should be abolished.

Paying the federal government bond is working within an unjust system to alleviate the suffering of people now. But our goal is to prevent anyone from ever having to suffer incarceration. The government justifies the system by assuming that if immigrants are not imprisoned, they will abscond and risk becoming a public charge. The truth is, the immigration detention system itself is the biggest charge on the American public.

Our taxpayer dollars fund this profit-driven system, enriching local governments and private prison corporations at the expense of us all. This fund will demonstrate that people are imprisoned solely because they cannot afford to pay an immigration bond, but when we are able to finance their freedom they are able to concentrate on winning their immigration cases and comply with what the government is asking of them. We are advocating for divestment from inhumane systems of incarceration and investment in community organizations that support and welcome immigrants.

Finally, how can people get involved? Who can be an investor?

LG: Anyone can donate to Freedom for Immigrants, or consult with your financial advisor about whether it's appropriate for you to invest in the fund through a charitable vehicle like a donor advised fund at your favorite community foundation. While only accredited investors are eligible to consider a direct investment in the Freedom100 Fund, we encourage everyone to learn more about collectively ending immigration detention by visiting Freedom for Immigrants site.

Thanks to Jasmine Rashid for her contributions to this piece. Full disclosures related to my work available here. This post does not constitute investment, tax, or legal advice, and the author is not responsible for any actions taken based on the information provided herein.

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Blended Capital For Immigration Bonds: Introducing The Freedom100 Fund - Forbes

UWI economics from the 1970s (Part 1) – Jamaica Observer

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BSc (Econ) UWI: the sixth former in Kingston had scribbled this on the inside cover of his economics textbook, Intermediate Economics by J Harvey, in about 1977. This was an aspirational note. In the UWI system, after three years of post-sixth form studies, the degree could be his.

Naipaul's Primer

The aspiration was perhaps more practical and reachable than that scribbled by VS Naipaul at Queen's Royal College on his fourth form Latin primer to leave Trinidad in five years. Naipaul fell short by a year on his ambition, but he eventually assumed his cosmopolitan mantle. From under this mantle he elaborated on his schizophrenic relationship with his homelands, starting with the comic atmosphere of Miguel Street and The Mystic Masseur, but graduating to bitter ridicule and scorn in later years.

BSc (Econ) UWI circa 1978 was to be a passport not to lucre, but to learning, knowledge and, with good luck, probably to wisdom. And so, those embarking on the Mona experience did so armed with the view that studies in economics would be an avenue for both personal and professional advancement.

First year (1978)

In the first year of BSc (Econ) UWI, with classes frequently held in N1 of the Arts block (now the Neville Hall Lecture Theatre), the economics neophytes shared ideas with management students (in superior numbers), future sociologists, and budding political scientists.

The lecturers included the highly rated Ramjeesingh, in economics and in statistics, Dr Roach in mathematics, the thoughtful Rupert Lewis for politics, the perceptive Bernard Marshall for history on Mondays and Fridays at 5:00 pm, and two leading sociologists, Barry Chevannes and Don Robotham.

The first-year lecturers exposed students to dialectical materialism, The Labour Theory of Value, The State in theory and practice, Durkheim , The Protestant Ethic and the Spirit of Capitalism, Schumpeter and other ways of seeing. These other ways of seeing were, almost literally, new methods of understanding social and economic phenomena; for, at the high school level, neoclassical demand and supply curves, Keynesian macroeconomic principles and production possibility frontiers had been predominant on the Cambridge A' Level syllabus. Now, the student was challenged to put other instruments in the toolbox of socio-economic analysis.

Eurocentric?

Was the new toolbox too Eurocentric? In the first year there was steady exposure to Marx and other (mainly) 19th century writers in economics, politics and sociology; but there was also significant exposure to Caribbean scholarship of quality. Question 1 on the tutorial sheet for Introduction to Politics in 1978 was about Marcus Garvey: Garvey preached racial pride but the main point of his work was anti-imperialism. Discuss.

This was promptly followed by a question which required students to consider the role of the media in the Commonwealth Caribbean, with readings from Caribbean Quarterly and other regional sources. In addition to Caribbean Quarterly, the book Essays on Power and Change in Jamaica (edited by the illustrious pair of Carl Stone and Aggrey Brown) proved to be particularly stimulating. Especially stimulating too were politics tutorials under the experienced hand of Ann Spackman, who challenged all shortcuts European or otherwise and was said to be doctrinally opposed to giving 'A' grades, a characteristic rumoured to be shared with some senior denizens of the UWI History Department of the time.

It may have been in the Introduction to Politics final examination for 1978-79 that students were called upon to assess how, and to what extent, poor countries owe their underdevelopment to developed countries. This question, of course, was built on a premise constructed in part by Walter Rodney, the highly rated Mona historian who had been declared persona non grata by the Hugh Shearer Administration a decade earlier. The question, too, could have been connected to Tanzanian President Julius Nyerere who, on a celebrated, rain-bearing, visit to Jamaica in 1974 eloquently maintained that in international relations the poor remain poor because they are poor.

IMF bank?

For the following year, Question 1 on the Introduction to Politics final examination was, I think: Is the IMF a bank? The background to this question may have been a statement by Andrew Young, then the US ambassador to the United Nations. Ambassador Young, on a visit to Jamaica in 1977, argued that the International Monetary Fund, as a bank, had the right to impose conditionalities on Jamaica in return for their loans to the country in the same way that a bank would do to its debtors. Against a background in which BSc (Econ) students were reading Cheryl Payer's The Debt Trap: The IMF and the Third World, Young's analysis was the subject of much contention on the campus and presumably on the examination paper.

Eric Williams

Our history exposure in the first year was fundamentally and unapologetically Caribbean. Eric Williams' From Columbus to Castro and Capitalism and Slavery were on the top bookshelf. The former was rated for its broad view of developments in Caribbean history, readable style and its unexpected witticisms (Columbus fell on his knees and then on the Aborigines). And the latter, based in large part on Williams' doctoral thesis at Oxford, brought home to the sceptical, postcolonial reader the fact that humanitarianism and the work of the Saints were not the only factors in the abolition of the British Caribbean slave system.

Other history items on the top shelf were photocopied essays that included Roy Augier's path-breaking Before and After 1865, Elsa Goveia's New Shibboleths for Old, and Douglas Hall's presentation on the apprenticeship system in Jamaica (with planters 'squeezing the last ounce of juice' from the enslaved).

From the first year it was clear that the Caribbean authorities would not always agree with each other: New Shibboleths, for example, was a surgical critique of some aspects of Williams' work that must, at very least, have put the original prince of Port of Spain on the back foot for a few weeks. These and other offerings were consumed with pleasure, with students engaging in long arguments about how history should inform praxis.

Mathematics

BSc (Econ) in the second year took on a specialist tone and mathematics sat upon its throne. The student grapevine spoke unequivocally: Basic Mathematics for Economists was a misnomer. To begin with, basic maths involved differentiation and integration in calculus at a considerably more complex level than was required for mathematics and statistics.

So, in much the same way that the Jamaican Supreme Court is not really supreme, basic maths was not really basic. When the lecturer, Dr Roach, informed the class that the Kolmogorov-Smirnov test would not be appearing on our final examination paper, there was a loud chorus of relief throughout the lecture room (SR 4, Social Sciences).

Dr Roach was a methodical and quiet mathematician who never seemed perturbed by challenging questions. He was based full-time at the then College of Arts, Science and Technology (CAST) but offered his considerable skills to Mona students; in a small, developing society, sensible people are prepared to share knowledge and to acknowledge needs.

Statistical method

The realm of king mathematics also extended to Economic Statistics, Statistical Method, and Elementary Econometrics. Economic Statistics was taught by John Gafar from Guyana. Gafar lived for cricket, pointing out in his first class of the year that if Test cricket was being played at Sabina Park, students would not see him at Mona. This hypothesis was not tested. In the statistics courses, however, several economic hypotheses were subject to testing, at given degrees of freedom.

Students were also asked whether certain estimators were sufficient, unbiased or consistent; invited to reach precise, technical conclusions about variance, normal distribution and to evaluate probability using Chebychev's inequality, and other methods. A part question on the Statistical Method final examination for June 1981, in the pre-COVID-19 era, captures the flavour of the lecturers' expectations. Question 4 (a) read:

The probability that a person who is exposed to a certain contagious disease will catch it is 0.20. Find the probability that the 20th person exposed to this disease is the fifth one to catch it.

This was in all probability a question from the pen of the aforementioned Dr Roach.

In the book

For years before and after 1981, Professor Al Francis was responsible for guiding students through the pleasures and pains of Elementary Econometrics. As was the case with Basic Mathematics, there may have been a structural error in the naming of the course, for while econometrics was much in evidence, the adjective elementary was distinctly misleading. Prof was, however, a born teacher who gave us the intellectual tools to take on concepts such as ordinary least squares estimators, multicollinearity, dummy variables, and the Koyck transformation with confidence.

Prof Francis also gave students the will and the skill to guide themselves through difficult, technical material. If a student asked a question about an item not covered in lectures, Prof's first line of response with a smile was apt to be, But it is in Johnston read it and let me know how you get along, withJohnson being Econometric Methods, the assigned textbook. Prof, who had taken his doctorate at MIT, ensured that his econometric students were prepared to match the best in the world.

Al Francis

On top of Prof's expertise and pedagogical skills were layers of determination and modesty. It is reported that the young Al Francis opened the batting for Kingston College in his time playing Sunlight Cup cricket. His opening partner was Easton Bull McMorris who went on to captain Jamaica and open for the West Indies (as highlighted in recent editions of the Sunday Observer). And at one down on the KC side was Collie Smith, the legendary West Indian star batsman who left us early.

At very least, then, Prof batted with the stars and could make his own claim to cricketing greatness. He also represented the school at football, and his academic achievements took him to some of the most renowned institutions in the world.

And yet, Prof studiously avoided autobiographical comment to those within his charge. He was more inclined to talk about a book he had just finished reading, to discuss the mathematical principles behind autocorrelation, or to reflect on the need for better basic schools in Jamaica, than to elaborate on his life achievements.

The early 1980s saw Prof Francis leave the Department of Economics to go, for a time, to a senior position at the International Bauxite Association. There, he noted, the view from his office in New Kingston directed to the hills of St Andrew and further north was more impressive than that from his ground floor office on the corridor at Mona. But his heart was at Mona, and so, he returned home.

Coming next: Other lecturers and the times.

Ambassador Stephen Vasciannie is Professor of International Law, UWI, Mona.

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UWI economics from the 1970s (Part 1) - Jamaica Observer

The Interisland Travel Quarantine Is Coming Back, Oahu Beaches And – Honolulu Civil Beat

Following record new cases of COVID-19 statewide, Hawaiis governor and the Honolulu mayor are bringing back sweeping restrictions that were in place at the beginning of the pandemic and creating a special police unit to cite and arrest violators.

Starting on Tuesday, anyone arriving in Kauai, Hawaii, Maui or Kalawao counties will be required to quarantine for two weeks. The quarantine requirement does not apply to those arriving on Oahu.

Gov. David Ige said at a press conference Thursday afternoon that the quarantine rule would apply to all interisland travel, but his office later sent out a press release saying it will only affect travelers arriving in Kauai, Hawaii, Maui and Kalawao not Oahu.

Because of the surge in cases on Oahu, all the county mayors agree that additional measures are necessary to make sure cases do not spread uncontrolled across all counties, Ige said.

Mayor Kirk Caldwell is once again ordering the closure of island beaches and parks.

Cory Lum/Civil Beat

On Oahu, where coronavirus cases have surged, Mayor Kirk Caldwell has issued a new order called Act With Care Do Not Gather. It takes effect Friday at midnight and will be in effect until Sept. 5, he said.

All city and state beaches and parks will be closed again. They were previously closed from mid-March through mid-May.

There will be no activities allowed on the beach or in the parks, Caldwell said. You can traverse the parks to get to the water to surf, to swim, to paddle, to dive, fish and do other Native Hawaiian gathering rights but in the water. Not in the parks, not on the beaches.

Hiking trails in city and state parks will also be closed, although trails run by the Hawaii Division of Forestry and Wildlife will remain open, the Hawaii Department of Land & Natural Resources said on Friday. Spokesman Dan Dennison said the state park closures are necessary because many are adjacent to beaches, which are the areas where large groups have been congregating.

You dont typically see 100 people at a party out on the trail, he said in an email. I would add that if theres evidence of crowding and large gatherings on trails, additional closures would be considered. I remember State Epidemiologist Dr. Sarah Park saying that people who keep six feet apart on a trail, mask-up when passing, and limiting group numbers are likely at low risk.

Public restrooms and showers will remain open. Parking lots for parks where vote by mail deposit boxes are located will remain open through Saturdays primary election but will be closed after, Caldwell said.

Campgrounds and botanical gardens will be closed. All team sports are banned. City and private pools, including hotel pools, will be shuttered. Indoor businesses including bowling alleys, arcades and mini-golf facilities must cease operations. Private tennis clubs will be closed.

The park closures include the shuttering of playgrounds, tennis courts, dog parks, skate parks, the Koko Crater Tramway and the Peoples Open Markets, according to the Honolulu Parks and Recreation Department. Parking lots for scenic lookouts will be closed.

The goal is to eliminate large, uncontrolled gatherings, such as groups who congregate under tents at beach parks, Caldwell said.

Honolulu Police Department Chief Susan Ballard said dozens of police officers will be looking for COVID-19 rulebreakers.

Cory Lum/Civil Beat

Im sure youve seen it when youve gone to the beach on the weekend, he said. So, bright line, easy to enforce. Parks are closed.

Hawaii Department of Health Director Bruce Anderson said officials believe large outdoor gatherings may be contributing to the rise of cases, although he didnt cite any specific clusters.

We think thats one of the most likely sources of exposure for a lot of the cases where we arent able to identify other sources, he said.

The federal Centers for Disease Control and Prevention say the risk of COVID-19 transmission is much higher when indoors where space is tighter and ventilation is limited.

But some indoor businesses on Oahu will be allowed to stay open. Gyms, where contact tracers have identified COVID-19 spread, can continue to operate except for group classes, Caldwell said.

Restaurants can remain open, although staff members, including those in the kitchens, must wear masks. Hair salons, massage parlors, tattoo shops, spiritual services, museums, art galleries and movie theaters can stay open. Golf courses and the Koko Head Shooting complex will remain open, Caldwell said.

Whats open are things that we can control, Caldwell said. Where there is compliance and not uncontrolled gatherings, we feel we should not punish those folks and crack down where the problem resides.

Oahus new wave of closures follows last weeks shutdown of Oahus bars for three weeks. They had just reopened on June 19. Caldwell added that the city will shutter bars that are posing as restaurants.

The most important part of the order is enforcement, Caldwell said.

Honolulu has created a COVID enforcement team of 160 sworn police officers who will respond to reports of violations and patrol islandwide seven days a week, said Police Chief Susan Ballard, who also spoke at the press conference. Starting Sunday at 10 a.m., people can report violations to a new hotline at 808-723-3900 or online at HPDCOVIDenforce@honolulu.gov.

At this point, were probably going to do very few warnings, she said. Its going to be either citations or arrests.

Im just begging you, please, Ballard said.

We need to get our island open, she said. We need to get back to normal.

The chief noted that homeless people are not exempt from most of the mayors order. Anyone found in a closed city park can be ticketed or arrested, she said. A review of emergency proclamation citation data by Hawaii News Now found that prosecutors have been dismissing thousands of citations given to homeless people during the pandemic.

Nonetheless, Ballard said her officers will continue to issue them.

If theyre in the parks and theyre not supposed to be, they could get cited and possibly arrested, she said.

Ige said the new wave of restrictions is necessary so that COVID-19 patients dont flood the islands hospitals.

While our health care system has managed and can manage the current level of cases, the hospitals have warned that if the trend continues, we will begin to reach a critical point that can overwhelm the health care system, he said.

Department of Health Director Bruce Anderson said more COVID-19 deaths and hospitalizations are inevitable.

Cory Lum/Civil Beat

Anderson said it is alarming to see the spike in cases, including two deaths on Wednesday and 152 new cases Thursday. With the new cases come more hospitalizations and more patients in intensive care, he said.

We are approaching a health care crisis and bold measures are needed now to stem the increase and the spread of COVID-19 in Hawaii, he said. The current situation is actually much more serious than we projected when we anticipated increases as the state reopened.

Hilton Raethel, president and CEO of Healthcare Association of Hawaii, said Oahu hospitals are poised to run out of ICU bed capacity by the end of this month, a dire situation he said the state has never faced before.

Hawaii hospitals have contingency plans for dealing with a major health crisis. They include converting acute care beds which are usually used for people recovering from surgery or disease into ICU beds, which are designed for complex, specialized care. But no Hawaii hospital has ever had to put one of these plans in effect, Raethel said.

The problem is if the infection rate continues to grow we will not only exceed our current capacity, but we will blow through our expansion capacity as well, he said.

Then we will run the risk of facing those incredibly difficult challenges of who gets a bed, who gets a ventilator, who gets the drugs, who gets the care. We do not want to get to that point where we are literally facing life or death decisions about who gets care and who doesnt get care.

People gather near the Kapahulu Groin in Waikiki on Thursday. Beaches and parks as well as other outdoor venues will be closed beginning Saturday morning for the next four weeks in an effort to control the spread of the coronavirus.

Cory Lum/Civil Beat

All the ICU beds at Kaiser Permanentes Moanalua Medical Center were full yesterday, according to Raethel. The only way to turn this trajectory around is for the public to work together to slow down the infection rate, he said.

Efforts to hamper the spread of the virus will not yield lower hospitalization rates for another two weeks because of the time it takes for symptoms to develop. Neighbor islands are not in such dire circumstances right now because the infection rate is much lower, Raethel said. But he noted that the public health resources on neighbor islands are more limited.

As of Thursday, 117 people were hospitalized with COVID-19 in Hawaii 115 of them on Oahu and 54% of ICU beds are filled, Anderson said. About 10% of overall cases end up in the hospital, according to Anderson.

Community spread of the coronavirus on Oahu has already stressed public health infrastructure, including contract tracing efforts, Anderson said.

There will be more deaths and more hospitalizations in the weeks to come because of gatherings and other activities from crowding that occurred in previous weeks, he said.

Anderson noted it is especially tough to limit the spread of the virus in large, multigenerational households where its hard for people to isolate and stay home from work when theyre sick.

The governor did not provide any clarity on the plan to reopen schools or the University of Hawaii saying only that officials are working through the details.

We are looking at a number of things, he said.

Board of Education Chairwoman Catherine Payne said Thursday she expects more clarity in the next few days or by early next week about how the increase in COVID-19 case numbers will impact schools, particularly on Oahu.

The new school year is set to begin Aug. 17, through a mix of virtual learning and in-person instruction across the state. Teachers reported back to work on July 29.

I do not think we can afford to shorten learning any more, Payne said. Even if we do not have a perfect setup for distance learning for all students.

Civil Beat reporters Brittany Lyte and Suevon Lee contributed to this story.

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The Interisland Travel Quarantine Is Coming Back, Oahu Beaches And - Honolulu Civil Beat

The Jobs Recovery Is Not Yet Half-Way as Progress Slows – TheStreet

The BLS Employment Report for July shows employmentrose by 1.8 million in July following a gain of 4.8million in June, and 2.7 million in May. The unemployment rate fell slightly to 10.2%.

Initial Reaction

The Bloomberg Econoday consensus jobs estimate was +1.677 million and the unemployment rate consensus was 10.5%.

The BLS said that errors that plagued the household survey since March was not as bad this month.

BLS Error Rate

For March through June, BLS published an estimate of what the unemploymentrate would have been had misclassified workers been included. Repeating thissame approach, the overall July unemployment rate would have been about 1percentage point higher than reported. However, this represents the upperbound of our estimate of misclassification and probably overstates the sizeof the misclassification error.

According to usual practice, the data from the household survey are acceptedas recorded. To maintain data integrity, no ad hoc actions are taken toreclassify survey responses.

Add 1 percentage to unemployment rate for a better estimate.

Job Revisions

The change in total nonfarm payroll employment for May was revised up by 26,000, from +2,699,000 to +2,725,000, and the change for June was revised down by 9,000, from+4,800,000 to +4,791,000. With these revisions, employment in May and June combinedwas 17,000 higher than previously reported. (Monthly revisions result from additionalreports received from businesses and government agencies since the last publishedestimates and from the recalculation of seasonal factors.)

BLS Jobs Statistics at a Glance

Part-Time Jobs

Don't try to make sense of those numbers as they never add up. I list them as reported.

BLS Employment Report Statement

Total nonfarm payroll employment rose by 4.8 million in June, and the unemployment rate declined to 11.1 percent, the U.S. Bureau of Labor Statistics reported today. These improvements in the labor market reflected the continued resumption of economic activity that had been curtailed in March and April due to the coronavirus (COVID-19) pandemic and efforts to contain it. In June, employment in leisure and hospitality rose sharply. Notable job gains also occurred in retail trade, education and health services, other services, manufacturing, and professional and business services.

Unemployment Rate Seasonally Adjusted

The above Unemployment Rate Chart is from the BLS. Click on the link for an interactive chart.

Month-Over-Month Changes By Job Type

Hours and Wages

Average weekly hours of all private employees declined 0.1 hours to 34.5 hours. Average weekly hours of all private service-providing employees decline 0.1 hours to 33.5 hours. Average weekly hours of manufacturers rose 0.7 hours to at 39.7 hours.

Average Hourly Earnings of All Nonfarm Workers rose $0.07 to $29.39.

Year-over-year, wages rose from $28.05 to $29.39. That's a gain of 4.7%.

The month-to-month and especially year-over-year gains are very distorted because more higher-paid workers kept their jobs than lower-paid employees.

Average hourly earnings of Production and Supervisory Workers fell $0.11 to $24.63.

The decline is a good thing in that reflects more people returning to work.

Year-over-year, wages rose from $23.54 to $24.63. That's a gain of 4.6%.

For a discussion of income distribution, please see Whats Really Behind Gross Inequalities In Income Distribution?

Birth Death Model

Starting January 2014, I dropped the Birth/Death Model charts from this report.

For those who follow the numbers, I retain this caution: Do not subtract the reported Birth-Death number from the reported headline number. That approach is statistically invalid.

BLS Covid-19 Statement on the Birth-Death Model

The widespread disruption to labor markets due to the COVID-19 pandemic and the potential impact to the birth-death model have prompted BLS to both revisit research conducted in the aftermath of the Great Recession (2008-2009) and incorporate new ideas to account for changes in the number of business openings and closings. Two areas of research have been implemented to improve the accuracy of our birth-death model in the CES estimates. These adjustments will better reflect the net effect of the contribution of business births and deaths to the estimates. These two methodological changes are the following:

1: A portion of both reported zeros and returns from zero in the current month from the sample were used in estimation to better account for the fact that business births and deaths will not offset.

2: Current sample growth rates were included in the net birth-death forecasting model to better account for the changing relationships between business openings and closings.

BLS will determine on a monthly basis if the adjusted birth-death model described here continues to be necessary. We will disclose these changes each month in the Employment Situation news release. All months in the tables of net birth-death forecasts on this page include footnotes for any month in which a regressor was used to supplement the forecasts.

The Birth-Death model is essentially garbage but we likely will not find how distorted this is until the annual revisions next year.

Table 15 BLS Alternative Measures of Unemployment

Table A-15 is where one can find a better approximation of what the unemployment rate really is.

The official unemployment rate is 10.2%. However, if you start counting all the people who want a job but gave up, all the people with part-time jobs that want a full-time job, all the people who dropped off the unemployment rolls because their unemployment benefits ran out, etc., you get a closer picture of what the unemployment rate is. That number is in the last row labeled U-6.

U-6 is much higher at 16.5%. Both numbers would be way higher still, were it not for millions dropping out of the labor force over the past few years.

Some of those dropping out of the labor force retired because they wanted to retire. The rest is disability fraud, forced retirement, discouraged workers, and kids moving back home because they cannot find a job.

Strength is Relative

Its important to put the jobs numbers into proper perspective.

In the household survey, if you work as little as 1 hour a week, even selling trinkets on eBay, you are considered employed.

In the household survey, if you work three part-time jobs, 12 hours each, the BLS considers you a full-time employee.

In the payroll survey, three part-time jobs count as three jobs. The BLS attempts to factor this in, but they do not weed out duplicate Social Security numbers. The potential for double-counting jobs in the payroll survey is large.

Household Survey vs. Payroll Survey

The payroll survey (sometimes called the establishment survey) is the headline jobs number, generally released the first Friday of every month. It is based on employer reporting.

The household survey is a phone survey conducted by the BLS. It measures unemployment and many other factors.

If you work one hour, you are employed. If you dont have a job and fail to look for one, you are not considered unemployed, rather, you drop out of the labor force.

Looking for jobs on Monster does not count as looking for a job. You need an actual interview or send out a resume.

These distortions artificially lower the unemployment rate, artificially boost full-time employment, and artificially increase the payroll jobs report every month.

Seasonal Adjustments

The report this month is weaker than it looks. Huge seasonal adjustments were in play as were temporary Census jobs.

I discussed this yesterday evening in Seasonal Adjustments Likely to Boost Friday's Job Numbers

Recovery Will Take Years

Last month I notedThe Fed Promotes a Quickening that Takes Many Years

This report provides evidence. The recovery has slowed. Huge headwinds remain and the reopenings reversed in July.

The economy has added about 9.5 million jobs since the April lows.

However, jobs remain nearly 13 million jobs below the February 2020 peak. Millions of those jobs will not return.

Mish

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The Jobs Recovery Is Not Yet Half-Way as Progress Slows - TheStreet

Kanye Shares Inspirations, Works in Progress and Unreleased YEEZY Footwear Designs – HYPEBEAST

Taking a break from his controversial political efforts, Kanye West recently took to Twitter to offer a look into his creative mind. Being heavily active on the social media platform over the last few months, Ye posted an array of images accompanied by brief musings that highlight the weight of each image.

Sharing, inspirations, works in progress and unreleased YEEZY footwear designs, Kanye revealed just how many elements of the culture he currently has his hands in. Standing out amongst the string of tweets are the looks at early YEEZY footwear designs include a top-down image of circles made up of unreleased colorways, a closer look at a yellow-focused adidas YEEZY BOOST 700 model, progressive slip-on models and what Ye claims is an upcoming Derrick Rose sneaker.

Aside from sharing inspirations from Herzog & de Meuron and James Turrell, Ye also offered a look at some of his progressive architecture designs. Building on the contemporary nature of his ideas, the creative looks to now be focusing on underwater homes with boulder doors inspired by Indiana Jones. Riddled throughout the stream of images are color studies that often deal with iridescent tones and weathered workwear.

Rounding up the Twitter spree is a look at a giant YEEZY model inflatable that is coming soon, a look at a Japanese mecha model, wholesome image of Kanye and his mother during their time in China and a notable jacket from Virgil Ablohs Louis Vuitton Spring/Summer 2021 collection.

Catch Kanye Wests latest Twitter spree below.

In case you missed it, ENG and Onelove look to bring archive fashion to China.

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Kanye Shares Inspirations, Works in Progress and Unreleased YEEZY Footwear Designs - HYPEBEAST

Pelosi Cites Progress on Stimulus With Two Sides Still Far Apart – Bloomberg

House Speaker Nancy Pelosi said negotiations on a new virus relief package are making progress, but the two sides remained at an impasse on major issues with their self-imposed Friday deadline for an agreement looming.

With no deal immediately in the offing, President Donald Trump said Thursday he is ready to sign orders extending enhanced unemployment benefits for the jobless and imposing a payroll tax holiday for employers and workers.

Pelosi and Senate Democratic leader Chuck Schumer are scheduled to meet again Thursday with Treasury Secretary Steven Mnuchin and White House Chief of Staff Mark Meadows for another round of negotiations to try to bridge the gap between them on the cost and breadth of another stimulus plan.

We have been making some progress, proceeding in a positive way, Pelosi said at a news conference. Were not there yet.

With progress slow, Senate Majority Leader Mitch McConnell on the Senate floor accused the two Democrats of stonewalling in the talks.

But Pelosi faulted McConnell for waiting until last week -- after earlier rescue measures expired -- to make a counteroffer to the $3.5 trillion stimulus plan that the House passed in May.

The fact is, when they showed up last week, it was already too late to prevent a lapse of extra unemployment insurance benefits, Pelosi said.

Staff members from each team were working on various proposals ahead of the negotiating session among the four principals scheduled for 5 p.m. in Washington.

Neither side indicated it would walk away if an agreement cant be reached by Friday. But Mnuchin and Meadows said that unless some compromise can be found soon, more talks may be fruitless.

Our objective is to try to reach an understanding of the major issues by Friday, Mnuchin told reporters after Wednesdays meeting with Pelosi and Schumer. If we cant reach an agreement on the major issues, its going to be hard to complete a deal.

Meadows said the two sides are still trillions of dollars apart on a compromise.

Meadows also said the administration and Republicans have already given more ground than Democrats in talks. He said the administration has been looking at legal issues with the president using his executive authority to take steps, that also include extending a moratorium on evictions and forbearance on student loans.

The administration is looking at the possibility of using money from the $2 trillion stimulus passed in March that hasnt been spent to extend the supplemental unemployment benefits, according to a person familiar with the matter. But there are are potential legal hurdles to redirecting the money.

I dont think they know what theyre talking about, Pelosi said about the White House redirecting money.

She said she supported the president extending the eviction moratorium, though more money will be needed to help those behind on rent catch up.

The talks take on added urgency as time passes. The November general election is 89 days away and economic data show signs that the economy is still hobbling along. The Labor Department reported that applications for unemployment benefits fell more than expected, to the lowest since the pandemic started. But with claims still exceeding 1 million on a weekly basis, the job market has a long road to fully recovering.

Senate Appropriations Committee Chairman Richard Shelby said negotiations were at an impasse right now.

Theres optimism and then theres pessimism, the Alabama Republican said. Sometimes theyre far apart and get close together on some things. We might not get a deal.

Meantime, McConnell is officially postponing the Senates scheduled August break, which was to begin on Friday. He said senators can return home, but will be called back if theres a vote on a relief bill. The House is on break, but lawmakers there have been told they could be recalled to Washington on 24 hours notice.

With assistance by Steven T. Dennis, Saleha Mohsin, and Skylar Woodhouse

(Updates with Trump preparing orders on stimulus in second paragraph)

Before it's here, it's on the Bloomberg Terminal.

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Pelosi Cites Progress on Stimulus With Two Sides Still Far Apart - Bloomberg

COVID-19 in Africa: Dampening the storm? – Science

Coronavirus disease 2019 (COVID-19) has spread rapidly and extensively to most countries in the world, resulting in considerable mortality in Europe and the United States, as well as in numerous upper-middle-income countries in South America and Asia. Experts predicted millions of COVID-19 deaths in Africa because many countries in the continent rank poorly on the United Nations Development Programme's Human Development Index. However, more than 4 months after the first cases in Africa were detected, prevalence and mortality are still low. It remains unclear if Africa is really spared from substantial cases and deaths. However, differences between Africa and the most affected countries in reliable reporting and death registration, lockdown stringency, demography, sociocultural aspects, environmental exposures, genetics, and the immune system could help to explain the experience of COVID-19 in Africa.

Africa faces major health and socioeconomic challenges that should have allowed rapid transmission of COVID-19. These include a weak health system (per capita health expenditure of <$50 in most West African countries compared with >$2500 in Europe and the United States), population crowding, poverty, and unhygienic conditions (1). Population densities are very high in most African capital cities such as Dakar (12,617 persons/km2), Abidjan (11,155 persons/km2), or Lagos (13,909 persons/km2), whereas New York City has 7101 persons/km2. However, although community transmission was reported in many major African cities months ago, the predicted number of cases and deaths has not yet been observed (see the figure). Low case numbers are often attributed to insufficient testing. However, many African countries implemented testing early on, and, based on the Our World in Data database (2), more tests per the number of cases were carried out than in other countries at similar phases of the epidemic (see the figure). Regarding the number of deaths, few functional civil registration services and thus statistics exist on the continent, raising questions about the reliability of mortality data. Potential underreporting of COVID-19associated deaths would not be specific to Africa, but the margin of error could be wider. To date, African countries have not indicated acute health emergencies; however, reliable age-stratified data are needed to fully grasp the COVID-19 situation in Africa to allow appropriate measures to be taken.

Measures such as travel restrictions, curfews, and school closures were implemented early in Africa compared with other continents, often before an African country had detected a case (fig. S1). These early responses might have resulted in fewer imported cases and reduced intracountry transmission, allowing sufficient time to prepare the constrained health systems for diagnosis and to prepare strategies for quarantine, contact tracing, and social distancing on a continent that already has experience in such practices to control epidemics such as Lassa fever and Ebola. Although it is likely that the early lockdown in Africa contributed to the slow spread, containment measures are not fully respected in many countries. Most people work in the informal business sector, such as in traditional markets, making strict lockdown measures impossible to implement. Recently, some African governments have been pressured to relax lockdown measures, for example, to carry out congregational prayers in mosques in Senegal. It remains unknown whether relaxation of containment measures will result in increased cases or if other factors are at play.

The majority of COVID-19associated deaths occur in older people. Africa has a comparatively young population, with a median population age of 19.7 years for the continent versus 38.6 years for the United States. Africa's youthful population is reflected in the structure of age-stratified cases (fig. S2). Based on global age-specific case fatality rates for COVID-19 and the age demographics of Africa, COVID-19 deaths would be expected to be only four times (3), rather than the observed 40 times, lower than in Europe or the United States. However, no aggregated data on age-specific case or death rates are available for the continent. There is substantial intergenerational mixing in Africa, and, with more cases of subclinical infections in the young, it could be a matter of time before expansive numbers of cases and deaths are recorded. Alternatively, a more rapid development of herd immunity among the youthful population might lead to fewer severe cases. Data from antibody tests (serosurveys) should clarify if transmission was more widespread with a high rate of asymptomatic and mild cases in African countries than in other countries.

The genetic characteristics of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and human genetics may be among the reasons for low incidence of severe COVID-19 in Africa. Although the relative contribution from Africa to the SARS-CoV-2 GISAID (Global Initiative on Sharing All Influenza Data) sequence database is small, the isolates found in Africa are representative of the different clades of SARS-CoV-2 found on other continents (fig. S3). Thus, it is unlikely that strains of SARS-CoV-2 in Africa have reduced virulence. Moreover, African-Americans constitute a disproportionate burden of deaths in the United States, so it seems unlikely that the lower mortality from COVID-19 in Africa is due to genetic factors. Nonetheless, the COVID Human Genetic Effort consortium aims to elucidate whether genetics can play a role in the patterns of disease worldwide.

SARS-CoV-2 infection leads to a heterogeneous outcome. About 80% of symptomatic cases are mild to moderate, whereas 20% can develop severe respiratory disease and display high rates of mortality (4). The development of an effective adaptive immune response can limit viral infection, whereas uncontrolled activation of innate immune cells leads to a cytokine storm and hyperinflammation in the lungs, ultimately leading to acute respiratory distress syndrome (ARDS) and multiorgan failure (4, 5). Being able to suppress viral infection early or to temper excessive inflammatory responses are likely complementary mechanisms to prevent severe disease.

Most convalescent symptomatic COVID-19 patients develop virus-specific neutralizing antibodies as well as specific CD4+ and CD8+ T cell responses (5). The efficiency and adequacy of these adaptive responses to clear viral infections depends on multiple factors, including past or concurrent infections with other pathogens. For example, antibodies directed to the four human coronaviruses that cause common colds could cross-react and neutralize SARS-CoV-2 in humans (6), and preexisting cross-reactive T cells can be found in individuals that have not been exposed to SARS-CoV-2 (7), suggesting previous exposure to related human coronaviruses could generate immunological cross-reactivity (7).

There are considerable differences in environmental exposures in Africa, compared with Europe or the United States. Noncommunicable diseases (NCDs)such as cardiovascular diseases, obesity, and type 2 diabetesare risk factors for severe COVID-19. These environmentally and behaviorally driven conditions are increasingly recognized in urban centers in Africa, and most COVID-19 deaths in Africa have been in older people with NCDs. However, infectious diseases such as HIV, tuberculosis, malaria, and other respiratory infections or those caused by helminths (parasitic worms) are prevalent in Africa, but there is currently little information on whether, or how, these infections affect COVID-19 disease progression.

The distribution of coronavirus disease 2019 (COVID-19) cases and deaths per 1 million inhabitants per continent reveals surprisingly low rates in Africa (left). This is despite comparable levels of testing per confirmed cases across continents (right). The dotted lines show the number of tests performed per number of detected cases. Data are from European Centre for Disease Prevention and Control COVID-19 situation updates, United Nations World Population Prospects 2019, and Our World in Data (2).

It is increasingly recognized that the immune system is shaped not only by genetics but also by environmental factors, such as exposure to microorganisms and parasites. This educates the immune system to protect against invading pathogens not only specifically but also nonspecifically through, for example, trained immunity, which involves the reprogramming of innate cells that, on secondary encounter with a pathogen, can show a stronger response (8) or virtual memory (9). Virtual memory T cells (TVM cells) expand in response to cytokines such as helminth-induced interleukin-4 (IL-4), rather than through pathogen-specific antigens, leading to enhanced antiviral effector functions (9). Thus, it can be envisaged that TVM cells are more prevalent in people in Africa owing to the higher exposure to such pathogens. This could contribute to the control of SARS-CoV-2. Additionally, as postulated by the hygiene hypothesis, early and chronic exposure to pathogens leading to relentless immune cell activation in harsh environments induces a strong regulatory immune response to counteract excessive inflammation (10).

The ability to prevent excessive inflammation could be a critical parameter that is associated with COVID-19 outcome. Recent data suggest that inflammatory alveolar macrophages (AMs), which can arise from differentiation of recruited monocytes upon infection, are increased in the lungs of patients with severe COVID-19 (11). It is unclear whether these monocyte-derived AMs are an important source of the cytokine-release syndrome observed during SARS-CoV-2 infection or whether they are involved in the pathogenesis of ARDS. However, monocyte and macrophage inflammatory cytokines, such as IL-6, have been repeatedly observed to be a marker of severe COVID-19, and myeloid cells are thus likely to be associated with the hyperinflammation. Monocytes from African individuals with high exposure to pathogens can be less proinflammatory (12). Thus, their recruitment into the lungs might prevent high cytokine production and therefore lead to better outcomes of COVID-19. Moreover, the airway microbiota, as well as more distal gut microbiota, could play important roles in preventing or potentiating respiratory tract infections and modulating virus-induced inflammation, as has been shown for several respiratory viruses (13). The known variations in microbiota across geographical areas could thus also participate in modulating disease severity and should be studied.

Africa should be part of the roadmap for COVID-19 research. Although there are no available data on the immune responses in African COVID-19 patients, studies show clear differences in the activation, proinflammatory, and memory profiles of the immune cells not only in Africans versus Europeans but also among Africans with high and low exposure to microorganisms and parasites (14) (fig. S4). Does the difference in immunological profiles matter for the outcome of COVID-19 in Africa? This needs further investigation, and the pattern of COVID-19 in urban and rural Africa could be informative.

There are differences in opinion about whether the pattern of SARS-CoV-2 spread is different in Africa compared with that in the United States and Europe. So far, despite a paucity of data, it appears that the virus is spreading differently and potentially with an attenuated outcome in Africa. There has been limited testing of asymptomatic cases or of antibody titers. Therefore, it is unknown whether early interventions were successful in preventing transmission or whether there are differences in susceptibility between populations of different regions. Perhaps the COVID-19 pandemic can emphasize the need for widespread implementation of public health tools, such as high-quality data, accurate diagnostics for track and trace, good communication, and an effective vaccine. Early testing of vaccines in different regions of Africa is essential because the high degree of exposure to pathogens can limit some vaccine responses (15). The first COVID-19 vaccine testing is starting in South Africa (Ox1Cov-19 Vaccine VIDA-Trial), and others are planned. Hopefully, this will stimulate the full participation of Africa in research into the critical factors that hold the key to innovative solutions in the fight against the pandemic.

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COVID-19 in Africa: Dampening the storm? - Science

Pacific Biosciences and Asuragen Collaborate to Develop Assays for Carrier Screening and other Applications Based on SMRT Sequencing Technology and…

AUSTIN, Texas & MENLO PARK, Calif.--(BUSINESS WIRE)--Pacific Biosciences of California, Inc. (Nasdaq:PACB), a leading provider of high-quality sequencing of genomes, transcriptomes and epigenomes, and Asuragen, a molecular diagnostics company delivering easy-to-use products for complex testing in genetics and oncology, today announced their clinical research collaboration aimed at developing molecular assays based on PacBios Single Molecule, Real-Time (SMRT) Sequencing technology. The initial focus of the collaboration will be on research in support of assay development for the carrier screening market.

Several of the most common carrier genes for autosomal recessive and X-linked conditions are either technically challenging or inaccessible to amplify and sequence, leading to incomplete coverage and convoluted workflows spread over multiple platforms. Through this collaboration, Asuragen scientists will develop assays that combine the companys AmplideX PCR technology for enriching hard-to-amplify sequences with PacBio SMRT Sequencing, a highly accurate long-read sequencing platform with a unique ability to represent all regions of the genome and to detect any kind of structural or other variation.

Innovative amplification and sequencing technologies have each been instrumental in discovering and characterizing challenging disease-causing structural variants, such as indels, copy number changes, and repeat expansions, said Gary J. Latham, PhD, Senior Vice President of Research and Development at Asuragen. We are excited to work with PacBio to combine the best of both technologies to build assays that can uniformly resolve simple and complex forms of genetic variation for research and clinical applications.

Scientists at Asuragen will develop assays for PacBios Sequel Systems using Asuragens AmplideX PCR technology. AmplideX products are designed to solve testing needs in inherited genetic disorders through easy-to-run assays and optimized workflows that deliver best-in-class performance. Assays will make use of PacBios HiFi long reads, an approach incorporating multiple passes of the same molecule to create a highly accurate consensus sequence.

We are honored to partner with Asuragen, a leader in molecular diagnostics, to apply the unique value of SMRT Sequencing for clinical research, said Jonas Korlach, PhD, Chief Scientific Officer of Pacific Biosciences. Scientists have shown that PacBios long-read sequencing systems offer a high-resolution view of the human genome that is simply not possible with any other sequencing technology. We look forward to working with Asuragen to design assays capable of interrogating challenging genomic regions and identifying the full breadth of natural human genetic variation.

About Asuragen

Asuragen is a molecular diagnostic product company changing the way patients are treated in genetics and oncology. Asuragens diagnostic systems, composed of proprietary chemistry and software, deliver powerful answers using broadly installed instrument platforms. They are simple to adopt and expand the ability to serve patients. Asuragen is a product foundry rapidly and efficiently addressing current and emerging clinical needs, including cancer diagnosis and monitoring, reproductive health and aging, serving laboratories across a patients lifespan with its best in class diagnostic tests. For more information, visit http://www.asuragen.com.

About Pacific Biosciences

Pacific Biosciences of California, Inc. (NASDAQ:PACB), is empowering life scientists with highly accurate long-read sequencing. The companys innovative instruments are based on Single Molecule, Real-Time (SMRT) Sequencing technology, which delivers a comprehensive view of genomes, transcriptomes, and epigenomes, enabling access to the full spectrum of genetic variation in any organism. Cited in thousands of peer-reviewed publications, PacBio sequencing systems are in use by scientists around the world to drive discovery in human biomedical research, plant and animal sciences, and microbiology. For Research Use Only. Not for use in diagnostic procedures. For more information please visit http://www.pacb.com and follow @PacBio.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to market leadership, uses, accuracy, quality or performance of, or benefits of using, our products or technologies, including SMRT technology, the suitability or utility of our methods, products or technologies for particular applications or projects, the expected benefits of the research collaboration with Asuragen, the ability of the Company to be successful in reaching its technological and commercial potential, and other future events. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, changes in circumstances and other factors that are, in some cases, beyond Pacific Biosciences control and could cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Factors that could materially affect actual results can be found in Pacific Biosciences most recent filings with the Securities and Exchange Commission, including Pacific Biosciences most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption Risk Factors. Pacific Biosciences undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available.

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Pacific Biosciences and Asuragen Collaborate to Develop Assays for Carrier Screening and other Applications Based on SMRT Sequencing Technology and...

Kazia Therapeutics hits A$1 on grant of Rare Pediatric Disease Designation to paxalisib for DIPG – Proactive Investors USA & Canada

The US FDA has awarded RPDD to paxalisib for the treatment of Diffuse Intrinsic Pontine Glioma, a rare and highly aggressive childhood brain cancer.

() () has surged on being granted Rare Pediatric Disease Designation (RPDD) by the US FDA for its paxalisib for the treatment of DIPG, a rare and highly aggressive childhood brain cancer.

With RPDD granted, Kazia may now be eligible to receive a rare pediatric disease priority review voucher (PRV) if paxalisib is approved for Diffuse Intrinsic Pontine Glioma (DIPG).

A PRV grants the holder an expedited six-month review of a new drug application by FDA.

PRVs can be sold to other companies and have historically commanded prices between US$68 million and US$350 million.

Shares have been more than 78% higher in early trade to a new 3.5 year high of A$1.00.

Kazia CEO Dr James Garner said: Although glioblastoma remains our primary focus for paxalisib, we have been devoting increasing energy to developing the drug in childhood brain cancer as well.

"For patients diagnosed with DIPG, there are currently no FDA-approved drug treatments, and the average survival from diagnosis is around 9.5 months.

Garner said: "The granting of RPDD by the FDA recognises our efforts and achievements so far and leaves us well placed to move paxalisib forward as a potential therapy for DIPG.

"We continue to be inspired by the dedication of our collaborators in this field and are committed to understanding whether paxalisib may be able to help in this enormously challenging paediatric disease.

RPDD has been awarded following positive emerging preclinical data in DIPG and with initial clinical efficacy data expected in the current half-year, positive clinical data may substantially enhance the likelihood of a potential future PRV.

The US Food and Drug Administrations (FDA) RPDD program is intended to advance the development of drugs and biologics for certain serious and life-threatening rare pediatric diseases by providing incentives to industry.

Most significant among these incentives is the potential access of a priority review voucher at the time of a marketing authorisation for the rare pediatric disease.

RPDD may be granted to drugs in development for diseases which primarily affect children under the age of 18, have an incidence of less than 200,000 new cases per annum in the US and which are serious or life-threatening.

In October 2018, St Jude Childrens Research Hospital in Memphis, Tennessee, began a phase I clinical trial of paxalisib in DIPG (NCT03696355).

This study reported favourable top-line safety data in September 2019 and established 27 mg/m2 as the maximum tolerated dose for paediatric use.

The study has completed recruitment and initial efficacy data is anticipated during the second half of 2020.

This data will be used to guide future development of paxalisib (formerly GDC-0084) in this disease.

Dr Matt Dun and colleagues at the University of Newcastle, Australia have conducted extensive laboratory research with paxalisib, focused on phosphoproteomic analysis of its activity in DIPG cell lines.

Phosphoproteomics is a new approach in cancer research that attempts to discern how complex signalling pathways are modified in tumours.

Work at the Dun laboratory has shown paxalisib to be broadly active in DIPG and has identified a number of potential combination strategies which may enhance its activity.

Initial data was presented at the Society for Neuro-Oncology (SNO) Pediatric Neuro-Oncology Basic and Translational Research Conference in San Francisco, CA, in May 2019.

Further ongoing work in animal models is expected to provide additional insight.

In parallel, related laboratory research is underway in the DMG Research Center at the University of Zurich, Switzerland, under the leadership of Dr Javad Nazarian.

Dr Nazarian is also the principal investigator at Center for Genetic Medicine within the Childrens National Medical Center, Washington DC with a focus on DIPG.

Laboratory research is also being conducted at St Jude Childrens Research Hospital by Dr Chris Tinkle and Dr Suzanne Baker and colleagues, in parallel to the ongoing phase I clinical trial at that centre.

Read more from the original source:

Kazia Therapeutics hits A$1 on grant of Rare Pediatric Disease Designation to paxalisib for DIPG - Proactive Investors USA & Canada

Treatment Considerations for Prostate Cancer Progressing After Combination Therapy for mCSPC – UroToday

(UroToday.com) In conjunction with the Scientific Congress held as part of the American Society of Clinical Oncologys (ASCO) Annual Meeting in May 2020, an Educational Symposium was convened on August 8 to 10th. In a session entitled Sorting Through the Maze of Treatment Options for Metastatic Castration-Sensitive Prostate Cancer, Dr. Alicia Morgans from Northwestern University presented a plenary talk discussing the treatment considerations for patients who received combination therapy for metastatic castration sensitive prostate cancer (mCSPC). This followed prior presentations from Dr. Carmel Pezaro and Dr. Neal Shore regarding the role of chemotherapy and novel androgen axis inhibitors in patients with mCSPC.

Dr. Morgans began by highlighting that, as per National Comprehensive Cancer Network (NCCN) guidelines, combination therapy with androgen deprivation therapy and another agent (apalutamide, abiraterone, docetaxel, or enzalutamide) is recommended.

While there are a number of treatment options for patients with mCSPC, there is an even greater plethora of treatment options for patients with metastatic castration-resistant prostate cancer (mCRPC), with no less than seven different agents available on the basis of prior therapies received, patient characteristics, and tumor characteristics.

Clearly, prior lines of therapy (including those used in the mCSPC space) influence future treatment choices when the patient progresses to mCRPC. In the mCRPC disease space, treatment choices may be guided by the following factors, among others:

1. prior treatment received, with a preference for novel mechanisms of action2. treatment availability in practice setting/location3. presence of visceral metastasis or restriction to bone-only metastasis4. candidacy for chemotherapy, on the basis of patient comorbidity and frailty5. histologic characteristics, including the presence of small cell/neuroendocrine differentiation6. targetable genetic or genomic characteristics including actionable DNA damage repair mutations or presence of microsatellite instability high status7. availability of clinical trials

Dr. Morgans highlighted that resistance mechanisms can spread through metastasis-to-metastasis seeding and similar resistance patterns are often seen in geographic proximity suggesting an element of interclonal cooperativity. As a result, at the time of disease progression, the use of therapy with a novel treatment mechanism is necessary to counter to acquired resistance.

As a general principle, Dr. Morgans outlined that sequencing of androgen axis inhibitors (including abiraterone acetate, enzalutamide, apalutamide, and darolutamide) is generally poorly effective. To drive home this point, Dr. Morgans reviewed data from the CARD trial which randomized patients who had progression on one androgen axis targeting agent to a switch or to cabazitaxel. Only 14% of patients who switched to the other androgen axis targeting agent had a PSA response of 50% or more and median progression-free survival was only 2.7 months (95% confidence interval 2.4 to 2.8 months) in contrast to median progression-free survival of 4.4 months (95% confidence interval 3.6 to 5.4 months) among those randomized to cabazitaxel (hazard ratio 0.52, 95% confidence interval 0.40 to 0.68). Similarly, in PROfound, patients who had disease progression on a novel androgen axis inhibitor were randomized to physicians choice of therapy (often including a switch to another androgen axis inhibitor) or Olaparib. As with the CARD trial, patients randomized to a second androgen axis inhibitor had median progression-free survival of 3.55 months (hazard ratio 0.34, 95% confidence interval 0.25 to 0.47).

Apart from these randomized data, there are a number of other studies that have assessed response rates for sequencing of androgen axis targeting agents demonstrates generally short progression-free survival.

Dr. Morgans then highlighted data that may guide specific treatment considerations in particular populations. First, she reviewed data from the PROCEED observational registry of patients treated with sipuleucel-T. In a prostate-specific antigen (PSA) matched analysis, median overall survival was significantly longer for African American men (35.3 months) as compared to Caucasian men (25.8 months) (hazard ratio 0.70, 95% confidence interval 0.57 to 0.86). Further, baseline PSA at the time of initiating sipuleucel-T therapy was associated with survival patients with PSA below the median (29.5 ng/mL) had improved survival (hazard ratio 0.52, 95% confidence interval 0.37 to 0.72).

In an international early access program, observational data suggested that asymptomatic patients receiving radium-223 had significantly improved overall survival compared to those who were symptomatic at the initiation of therapy (hazard ratio 0.49, 95% confidence interval 0.33 to 0.73).

Beyond clinicodemographic factors, Dr. Morgans discussed genetic and genomically targeted approaches. She first examined data from TRITON2 in which patients with mCRPC and deleterious mutations in DNA defect repair (DDR) genes who had progressed on androgen axis targeting agents received rucaparib in a single-arm design. The vast preponderance of patients had a beneficial PSA response. Subsequently, the PROfound study reported a randomized comparison of Olaparib versus physicians choice among a similar patient population. They demonstrated significantly improved radiographic progression-free survival among those receiving olaparib (median 5.8 months) versus physicians choice of therapy (median 3.5 months; hazard ratio 0.49, 95% confidence interval 0.38 to 0.63). Great detail regarding the data for PARP inhibitors in prostate cancer is provided in a UroToday Center of Excellence article.

On the basis of these data, rucaparib has been approved for men with BRCA1/2 mutations who have progressed following androgen receptor-targeted therapy and taxane chemotherapy while olaparib has been approved for men with Homologous Recombination Repair (HRR) mutations following androgen receptor-targeted therapy, with or without prior taxane treatment.

Beyondpoly ADP ribose polymerase (PARP) inhibitors, pembrolizumab is another targeted option for men with advanced prostate cancer. In this case, patients must have microsatellite instability-high status to be eligible, as the United States Federal Drug Administration (FDA) has approved pembrolizumab in a tissue agnostic fashion for patients with microsatellite instability-high tumors. Dr. Morgans reported that approximately 2-3% of men with prostate cancer will have microsatellite instability-high tumors, and are therefore expected to have radiographic responses to pembrolizumab.

Dr. Morgans closed by highlighting the importance of shared decision making for patients with advanced prostate cancer. This is particularly important where there are so many treatment options. Patient preferences may be driven by home or work obligations, by past or vicarious experiences or fears, by insurance restrictions, and other factors.

Moving forward, Dr. Morgans highlighted the potential for theranostics, including the therapeutic role of Lutetium-177-prostate-specific membrane antigen (LuPSMA). A number of ongoing trials will assess the role of Lu-PSMA, including in a comparison against cabazitaxel in patients who have progressed following docetaxel and in comparison against best supportive or standard of care in patients who have progressed following both taxane chemotherapy and an androgen axis inhibitor.

Presented by: Alicia Morgans, MD, MPH, Associate Professor of Medicine in the Division of Hematology/Oncology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois

Written by:Christopher J.D. Wallis, Urologic Oncology Fellow, Vanderbilt University Medical Center,@WallisCJD on Twitteratthe ASCO20 Virtual Education Program, #ASCO20, August 8-10, 2020.

More here:

Treatment Considerations for Prostate Cancer Progressing After Combination Therapy for mCSPC - UroToday

Edited Transcript of PSNL.OQ earnings conference call or presentation 6-Aug-20 9:00pm GMT – Yahoo Finance

MENLO PARK Aug 8, 2020 (Thomson StreetEvents) -- Edited Transcript of Personalis Inc earnings conference call or presentation Thursday, August 6, 2020 at 9:00:00pm GMT

* Aaron L. Tachibana

Personalis, Inc. - CFO

Personalis, Inc. - Co-Founder, CEO, President & Director

Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst

* Subhalaxmi T. Nambi

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Caroline V. Corner

Good afternoon. My name is Jerome, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Personalis Q2 2020 Earnings Conference Call. (Operator Instructions)

Thank you. I would now like to turn the call over to Ms. Caroline Corner. Please go ahead.

Caroline V. Corner, Westwicke Partners, LLC - MD [2]

Thank you, operator. Welcome to Personalis' Second Quarter 2020 Earnings Call. Joining me on today's call are John West, President and Chief Executive Officer; and Aaron Tachibana, Chief Financial Officer.

This call will include forward-looking statements, including statements regarding the markets in which we operate, including potential market sizes; trends and expectations for products, services and technology; trends and demand for our products; Personalis' expected financial performance, expenses and position in the market; and the impact of the COVID-19 pandemic on our operations and our customers' operations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our most recent filings with the SEC, particularly the risk factors described in our 10-K filing for fiscal year 2019 and in our 10-Q filing for our second quarter ended June 30, 2020.

The forward-looking statements we provide during this call, including expectations for future performance, are based on our reasonable beliefs and expectations as of today. Personalis undertakes no obligation to update these statements, except as required by applicable law.

Our press release with our second quarter 2020 results is available on our website, http://www.personalis.com under the Investors section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5:00 p.m. Pacific Time today.

Now I'd like to turn the call over to John for his comments on second quarter 2020 business highlights.

John Stephen West, Personalis, Inc. - Co-Founder, CEO, President & Director [3]

Thank you, Caroline. Personalis has been responding to COVID-19 in -- began responding to COVID-19 in Q1 before government's shelter orders. That early response helped us have a record quarter in Q1. Our continued response and execution has now led us to another record in Q2.

In April, we coordinated with the VA MVP program to take the largest shipment of samples from them that we have ever had just before their lab in Massachusetts was closed in response to the pandemic. The automation that we've put in place over the last 3 years then allowed us to efficiently maintain our whole genome sequencing work, even when we had a reduced workforce in our lab as a result of operational changes we implemented to comply with state and local orders related to COVID-19 and to protect the health and safety of our employees. As a result, in Q2, we were again able to sequence about 14,000 whole human genomes, up 70% from Q2 last year and matching the Personalis population sequencing revenue record we had set in Q1.

On the oncology side of our business, we also had to adapt rapidly. Some prospective clinical trials that our biotech customers are involved with were either slowed or stoped due to the pandemic. And also revenue from our leading biobank customer fell 98% from Q1. We were able to overcome these challenges by beginning to ramp revenue from our next platform. This allowed us to achieve a sequential revenue increase for biopharma and all other customers. Most of our biopharma business is for retrospective projects, which have been resilient during this pandemic. Over the last 4 quarters, biopharma customer orders have significantly exceeded revenue, driven by adoption of our NeXT platform and predominantly by large pharmaceutical customers. As we saw in Q2, these orders are now beginning to convert to revenue.

Another challenge we faced during the quarter was the timing of biopharma sample receipts. Many were delivered to us later in the quarter than expected so we were not able to process all of them for revenue. This does, however, put us in a good position heading into Q3.

Our laboratory operations team executed well during Q2 and carefully arranged the sample processing schedules to focus on VA MVP samples early within the quarter when labor capacity was lower due to shelter-in-place guidelines. That allowed us to utilize more capacity later in the quarter for biopharma sample processing. As a result, our revenue from pharmaceutical customers increased by more than 20% sequentially. This more than offset the dip in revenue from biobank and biotech customers and helped us achieve quarter-on-quarter growth in our oncology-focused business.

Driven by this growth of NeXT, our overall revenue increased for a 16th consecutive quarter to $19.5 million, up 23% from Q2 last year. All of this was accomplished, while more than 80% of our employees were working from home.

Shifting focus to our progress this quarter, there are several factors which give us confidence in the long-term growth of our business. In the month of June, we were able to bring our liquid biopsy development team members back into the lab. You may have seen our recent press release launching NeXT Liquid Biopsy, which is now available for customer orders. Both our tissue and liquid biopsy-based products have been designed specifically to meet the needs of our pharmaceutical customers and provide data on all 20,000 human genes. With the addition of our liquid biopsy product, we expect to enable comprehensive monitoring of patients across 20,000 genes at multiple time points.

Many new cancer drugs extend the lives of patients but do not eradicate the disease. So a growing segment of the cancer survivor population consists of patients who are still undergoing active disease management. Our first liquid biopsy product tracks the evolution of what can be hundreds or even thousands of cancer mutations in a single tumor. Importantly, we can also detect new mutations as they emerge under therapeutic pressure. Note that some cancer patients develop a second genetically independent cancer while being treated for the first. Our liquid biopsy product's ability to see new mutations may also provide early detection of some so-called second cancers.

I'm extremely proud of our team. We pulled together during this challenging time to get this exciting product into the marketplace. We expect to receive first orders in the coming months. And while we expect that liquid biopsy revenues will be modest initially, we think this new product puts us in an even stronger competitive position as we go forward.

Our liquid biopsy product is designed to be used together with our tissue biopsy product, not instead of it. We expect initial sales to be to customers using our tissue-based testing, who are also seeking liquid biopsy capabilities to monitor the same patients over time. We believe that our capabilities to offer both tissue and liquid biopsy-based products and to leverage the synergy between them, positions us favorably relative to companies who only offer one or the other.

In the future, we will be broadening our liquid biopsy product line to include personalized tests designed for a specific patient's tumors. The team is hard at work here and barring any COVID-19-related interruptions or other unexpected delays, we expect to launch this additional offering in 2021.

We have continued to gain traction with biopharma customers, realizing strong order levels once again in Q2. To frame the pace of customer orders in a different way, in the first half of 2020, we received about the same dollar value of biopharma orders as we received for the full year of 2019. As we've explained before, it takes time for orders to convert to revenue and the actual revenue recognized from an order may be less than expected due to failure of individual customer samples to meet our sample quality requirements and other factors. But this growth in orders gives us confidence in our future revenue stream.

We are winning business based on the value proposition of our NeXT platform. Our NeXT platform can identify biomarkers, including neoantigens across all types of cancer, providing comprehensive data across all 20,000 human genes, all from a small tissue sample.

Our customer base has also grown substantially over the last year. While we can't disclose all of our customer names, I can tell you that we have now received orders from a majority of the top 10 oncology-focused pharma companies. As of the end of Q2, we had 32 different customers who have placed orders for NeXT, up from 26 at the end of Q1. In addition, you may recall that new customers typically evaluate or run a small pilot before growing into larger contracts. Up until the last few quarters, a pilot order could be around $50,000. But with our recent progress, we are now receiving initial orders that can be several hundred thousands of dollars. And in a few cases, approaching $1 million. We believe that this growing adoption of NeXT further highlights the power of our platform and that the comprehensiveness of our platform is important to our customers.

In June, we announced a research collaboration with Sarepta Therapeutics, a leader in precision genetic medicine for rare disease. As part of the collaboration, Sarepta is working with us to characterize immune response precision genetic therapeutics, utilizing our advanced proprietary neoantigen analytics. We are excited that the value of our platform is now being recognized in areas beyond cancer.

We also announced in June that we are establishing a lab and commercial operations in the People's Republic of China. Several global pharmaceutical companies have asked us about China, underscoring our belief that it's a good time to expand there.

Additionally, we recently announced a partnership with Berry Genomics, a Chinese company focused on the development and commercialization of genetic test technologies in clinical applications with approximately 1,500 employees and 7 different clinical laboratories. We believe that our partnership with Berry Genomics will be complementary since our customer focus is pharma and theirs is clinics and hospitals.

We have continued to expand our commercial team in both the U.S. and Europe. In particular, we have added business development staff with extensive commercial experience in companion diagnostic development. And as a result, we are now engaging with an increasing number of biopharma companies for potential companion diagnostic development programs. We've also expanded our quality and regulatory team to support these efforts. And in June, we had our first FDA pre-submission meeting for a single-site PMA for NeXT, which went well.

I'd now like to update you on the population sequencing part of our business, which is sometimes referred to in the field as population genomics. As you may have seen in our June press release, our population sequencing business hit a big milestone with the 75,000th full human genome sample sequence, and we are well on track to reach 100,000 by the end of this calendar year. This could make Personalis the first for-profit company ever to sequence 100,000 whole human genomes in the United States, and we are really looking forward to achieving this milestone.

Our work with the VA MVP represents the largest population sequencing effort within the United States. The VA now targets enrollment of 2 million veterans and over 825,000 veterans have enrolled so far. Personalis has been contracted so far to sequence over 116,000 VA MVP samples, with approximately 41,000 remaining to be sequenced.

Having already received population sequencing orders totaling over $145 million from the VA MVP, we are now expanding our commercial team to address and extend our reach into what is projected to be a multibillion-dollar population health market. We expect our unparalleled experience with the VA MVP program to position us well for new opportunities in population sequencing. Given our clinical experience and work with pharma, we also see an opportunity to help transition population research to population health and to involve pharma in the future.

Our population sequencing and biopharma businesses share a unifying theme in the comprehensive and large-scale genomic characterization of human samples. Both our whole genome sequencing and our NeXT platform cover all 20,000 human genes. Because of their shared underlying technologies and operational implementation, we achieved considerable synergy between the 2 businesses.

I would now like to expand on the synergy between the population sequencing and oncology parts of our business, in particular, synergies that go beyond the operational and cost synergies already achieved. Our extensive experience with whole genome sequencing, combined with our deep expertise in cancer, has allowed us to launch whole genome sequencing from cancer samples. We believe that this will be increasingly important in the future, particularly in cancers such as breast and prostate, which have relatively low mutational burdens.

Using our cancer whole genome technology will identify up to 20x somatic variants to serve as the basis for personalized cancer assays. We believe this will let us achieve high sensitivity, even in cancers which have low mutation rates, which have been surgically resected or which had relatively low amounts of cell-free DNA into the blood. We believe this can be a leading technology in some very large market opportunities, and we'll have more to say about this as these product developments progress.

Before I wrap up, I'd like to give you an update on another pipeline product. As many of you know, we have been working for over 3 years on a combined laboratory and informatics project to advance our neoantigen characterization capabilities. We believe that neoantigens are the crucial centerpiece of a new generation of companion diagnostic biomarkers. We expect our biopharma customers will apply this capability to mainstream cancer drugs such as checkpoint inhibitors and also to experimental personalized cancer therapies, which explicitly target neoantigens.

Our new advanced capability may also be used for development of drugs that are designed for use outside of cancer, such as gene therapies. This Personalis R&D project has required multiple proprietary technologies, including genetic engineering of proprietary human cell lines, mass spectrometry to identify and quantify peptides binding to HLA and the training of novel machine learning algorithms. Our data shows that this project has achieved a leapfrog advance in this field. We expect to launch this capability as part of our NeXT platform in the fourth quarter of this year.

In summary, I'm very proud that our combined business has shown strong resilience throughout the pandemic. Customer adoption for NeXT has been excellent, and our pipeline of compelling new products is rich. We believe these factors, among others, put us in a strong position for long-term growth.

With that, I will now hand it over to Aaron for our financial results.

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Aaron L. Tachibana, Personalis, Inc. - CFO [4]

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Thank you, John, and good afternoon, everyone. Revenues for the second quarter of 2020 were $19.5 million, up 2% from $19.2 million for the prior quarter and up 23% from $15.8 million for the same period of the prior year. The $19.5 million was a new record high for quarterly revenues. The quarter-on-quarter revenue growth was driven by an increase in volume for genomic testing services provided to biopharma customers. Biopharma and all other customers accounted for revenues of $4.7 million for the second quarter, an increase of 8% from last quarter.

In the second quarter, revenues from our NeXT platform began to ramp and exceeded $2 million. Also to note, the revenue increase from NeXT more than offset the sequential decline of over $1 million from both our biobank customer that had sample collection and shipment delays due to the pandemic and also biotech customers that were impacted by the slowdown of clinical trials.

For the second quarter, the VA MVP revenue of $14.8 million was flat from last quarter and was 73% higher compared with $8.5 million for the same period of the prior year. The VA MVP unfulfilled orders at the end of the second quarter were $39.3 million and based upon current estimates, we expect the unfulfilled orders to convert to revenue over approximately the next 2 to 3 quarters. The balance of the unfulfilled orders will decline from the fourth quarter of the prior year through the second quarter of the current year since the annual new order is typically received late in the third quarter.

Gross margin was 24% for the second quarter compared with 21.1% for the prior quarter. The VA MVP gross margins continued to be solid and once again were higher than the corporate gross margin reported for the second quarter. The VA MVP being higher volume and a single-service offering has been automated and does not require a significant amount of labor and has a very efficient sample test process.

In the second quarter, the negative impact to gross margin from COVID-19 was approximately 80 basis points from higher labor costs related to overtime pay. Also, we had a 100 basis point impact from higher facility costs related to an increase in lease rates. As a reminder, we may see gross margin variability in the future as there are a few moving parts, such as sample receipt linearity from customers, the mix of customer projects and capacity utilization of labor and equipment.

During our last conference call, we mentioned our initiative to build out a lab operation in China this year, which will add start-up expenses beginning in 2020, and most of these expenses will be classified as SG&A this year. We expect revenue from China to begin ramping throughout 2021. And during this ramp-up period, we expect to have gross margin headwinds from the under-absorbed labor and overhead.

Operating expenses were $14.2 million in the second quarter compared with $10 million for the same period of the prior year. R&D expense was $6.5 million for the second quarter compared with $4.5 million for the same period last year, and SG&A expense was $7.7 million in the second quarter compared with $5.5 million for the same period last year.

Net loss for the second quarter was $9.3 million compared with a net loss of $5.9 million for the same period of the prior year. The net loss per share for the second quarter was $0.29, and the weighted average basic and diluted share count was 31.7 million compared with a net loss per share of $0.89 and a weighted average basic and diluted share count of 6.6 million for the same period of the prior year.

Now on to the balance sheet. We exited the second quarter with a strong balance sheet with cash and short-term investments of $105.2 million. Second quarter cash flow from operations was a usage of approximately $15 million, primarily due to the net loss and working capital needs. During the quarter, we maintained our buffer inventory level of approximately $1.5 million to help mitigate potential supply chain disruption.

Now for discussion about our guidance. During our May conference call, we did not provide any 2020 revenue guidance due to the uncertainty from the pandemic. And although we had a solid second quarter, too much uncertainty remains about whether or not work conditions for us, our customers and suppliers will remain the same as today or change in the near future. Potential changes could have an adverse effect on our financial results. And therefore, we are not providing revenue guidance for fiscal 2020 at this time. We plan to provide an update to this information during our next earnings call.

Now I will turn the call back over to the operator, Jerome, to begin the Q&A session. Operator?

================================================================================

Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from the line of Doug Schenkel from Cowen.

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Subhalaxmi T. Nambi, Cowen and Company, LLC, Research Division - Research Associate [2]

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This is Subbu on for Doug Schenkel. You posted a great update intra-quarter on the VA update. Given that you're on track to complete the project, how long -- so most of the database, given that you're on track to finish 100 case sequences, most often, we notice that database that has integrated electronic health record data has more value. Do you envision that to happen with the VA MVP project?

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John Stephen West, Personalis, Inc. - Co-Founder, CEO, President & Director [3]

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Yes. This is John West. I'm happy to answer that. Actually, a part of -- key part of the advantage that the Million Veterans Program has is that veterans have all been on the same electronic medical record system for years. And so they already have that in electronic format. And unlike other population sequencing efforts, they don't have to try to harmonize results from many different electronic medical record systems. All of the patients that are handled by the VA MVP are patients who would be -- have been on the same electronic medical record system during their time as patients with the VA. So it's actually really a major advantage that they have. I would also say that we're coming up on the 100,000 patients. That's nowhere near finishing the project. The project is the sequence -- to enroll 2 million patients. There are actually 825,000 samples that have already been collected. So actually, we're just beginning to scratch the surface of the project. We've been contracted to sequence 116,000, and we anticipate that there can be an additional order still this year that will extend the program even further.

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Subhalaxmi T. Nambi, Cowen and Company, LLC, Research Division - Research Associate [4]

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So you -- so if I heard it right, you're already doing that. You already have data with the -- the electronic health record data of all these individuals. Or do you plan to do that in the future?

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Aaron L. Tachibana, Personalis, Inc. - CFO [5]

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Let's see, our customer already has that information in the VA. They're the ones who have that health record data. They're the ones sharing it. It will be their database. They're the ones paying for it. But they do already have all of that health record data.

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Subhalaxmi T. Nambi, Cowen and Company, LLC, Research Division - Research Associate [6]

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Got it. And you recently partnered with Berry Genomics, and you also said that, that will serve as your local subsidiary opportunity. How do you plan to strategize that, given that NGS testing has just begun gaining traction there, and there are already a few high-profile local players? So what would be the key advantage? Would you call it your core technology? Or is there some other strategy that you're working on?

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John Stephen West, Personalis, Inc. - Co-Founder, CEO, President & Director [7]

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Yes. So thank you for the question. So the key reason that we are expanding to China is that there are international pharmaceutical companies that we already work with in the U.S. and Europe who are conducting international clinical trials. And so they have patients who are being enrolled into those clinical trials from China now in addition to other countries. And we've already been sequencing samples from patients that are from countries outside of China, but our pharmaceutical customers came to us and said, we're not allowed to export the samples of patients from China. We can't send them to you in California. They have to be sequenced inside China because of the regulations of China. And so they've asked us to set up this additional capability using our proprietary technology, our NeXT platform, to be able to run that inside China.

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Operator [8]

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Your next question comes from the line of Kevin DeGeeter from Oppenheimer.

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Kevin Michael DeGeeter, Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst [9]

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Congrats on a really nice quarter. Can you just talk a little bit about the recently launched liquid biopsy program? Specifically, in addition to breadth of coverage, how else do you envision differentiating the product in the market, at least initially? And then in terms of the, what I'll call, incremental or second-generation product that would provide additional functionality for really kind of personalized precision oncology programs, just kind of walk us through the development steps that may be necessary to have that functionality.

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John Stephen West, Personalis, Inc. - Co-Founder, CEO, President & Director [10]

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Read the original here:

Edited Transcript of PSNL.OQ earnings conference call or presentation 6-Aug-20 9:00pm GMT - Yahoo Finance

Ovid and Angelini partner on treating Angelman syndrome in Europe – Pharmaceutical Technology

]]]]]]>]]]]>]]> Verona will use the financing to support further development of its nebulised COPD drug ensifentrine. Credit: Shutterstock.

Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.

Chronic obstructive pulmonary disease (COPD) specialist Verona Pharma has closed an oversubscribed private placement and subscription with $200m raised from existing and new investors.

Once agency fees and other expenses are dealt with, the net proceeds of the placement are estimated to be around $183m.

The financing was led by new investors RA Capital Management, Access Biotechnology, Perceptive Advisors, Acorn Bioventures, PBM Capital, Samsara BioCapital, Foresite Capital, Sphera, Fairmount and Soleus Capital. Novo Holdings, Vivo Capital and other existing investors also participated in the placement.

Commenting on this financing, Verona CEO David Zaccardelli says: It is great to retain this expertise and to expand on it by adding additional support from new investors who also have deep knowledge of investing in drug development.

Verona is a public company listed on Nasdaq and the London Stock Exchanges AIM, which means it is more typical to raise funds through private placements of debt or stock, rather than through series rounds, explains Zaccardelli. He adds that the company is very pleased to have raised almost four times its market capitalisation, and calls this raise unprecedented.

Zaccardelli links the oversubscribed nature of this private placement to investors seeing value in our compelling and comprehensive data package for lead product ensifentrine for COPD, compared to placebo. Attracting such support provides a validation ofVeronaPharmas team, strategy and the potential opportunity for ensifentrine in respiratory disease, he adds.

Ensifentrine is a first-in-class drug, which combines a bronchodilator and anti-inflammatory agent into one molecule. Verona believes it has the potential to revolutionise COPD treatment, which currently involves dual or triple therapy with long-acting muscarinic antagonists (LAMAs), long-acting beta adrenoceptor agonists (LABAs) and inhaled corticosteroids, explains Zaccardelli. Not only is this approach burdensome on the patient, the combination fails to relieve the symptoms of millions of COPD patients.

New therapeutic options are urgently needed since the World Health Organization estimates the incidence of COPD is growing, and the lung disease is likely to be the third biggest killer in the world by 2030.

Verona is planning to use this $200m financing to fund Phase III trials of ensifentrine in COPD. These trials are expected to start later this year, and the funding will support the studies through to 2023. One of the trials will focus on ensifentrine as a monotherapy, and another will assess its efficacy as an add-on to either a LAMA or a LABA.

Zaccardelli concludes: The financing is a significant milestone and brings us closer to our goal of ensuring ensifentrine is available for the millions of COPD patients who urgently need better treatments.

Veronas Phase III programme for ensifentrine known as ENHANCE is being launched on the back of very promising results for ensifentrine in a Phase II programme that involved 16 clinical trials in a total of 1,300 patients.

In a statement, Zaccardelli noted: We continue to be very encouraged by the Phase II results that have demonstrated ensifentrines effects on lung function, COPD symptoms and quality of life as well as its favourable safety profile.

Although Verona has focused on studying ensifentrine in a nebulised formulation so far and this will be focus of the ENHANCE trials the company recognises patients may prefer handheld inhaler formats. Therefore, it has developed formulations of ensifentrine in dry powder inhaler and pressurised metered dose inhaler formats, according to Zaccardelli.

Verona has undertaken two successful Phase II trials of both dry power inhaler and pressurised metered dose inhaler formulations of ensifentrine in the last year. Following the publication of interim results in March 2020, the second half of the pressurised metered dose formulation trial has been postponed due to the Covid-19 pandemic.

To date, there have been no announcements from Verona about progressing these two formulations into Phase III studies.

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Ovid and Angelini partner on treating Angelman syndrome in Europe - Pharmaceutical Technology

Doctoral Student/Research Assistant in Mitochondrial Biology and Signalling job with UNIVERSITY OF HELSINKI | 218596 – Times Higher Education (THE)

The University of Helsinki as research-oriented university offers a stimulating and international environment. The Faculty of Medicine of the University of Helsinki, together with Helsinki University Central Hospital, The Helsinki Institute of Life Science, and the Institute for Molecular Medicine Finland forms the Academic Medical Center Helsinki. This medical campus ranks among the 10 best medical centers at European level and the 50 best centers in the world. More info on the Faculty or Medicine and AMCH can be found here:

https://www.helsinki.fi/en/faculty-of-medicinehttps://www.helsinki.fi/en/meilahti-campus

Faculty of Medicine, Jackson laboratory, invites applications for a position of Doctoral Student / Research Assistant in mitochondrial biology and signalling for a fixed-term

The focus of the lab is to unravel fundamental signalling pathways and mechanisms controlling mitochondrial function. We are particularly interested in how mitochondria adapt signalling to metabolic cues in models of dysfunction including primary mitochondrial patient cell lines, cancer and associated disorders. We aim to exploit this knowledge on basic principles of mitochondrial signalling and subsequent metabolic susceptibilities in cellular models to help devise novel treatments of diseases that stem from misregulated mitochondrial function.

In this role the candidate will have the unique opportunity to drive an exciting project addressing limiting metabolic pathways in models of mitochondrial dysfunction by genome-wide CRISPR screening and mitochondrial structural analysis. The successful candidate will have access to a wide range of methodologies with work consisting in preparation of cell models, construction of libraries, and analysis of metabolic, proteomic and microscopic data at the cellular level.

We are looking for a highly motivated independent researcher with prime analytical skills driven by a passion for science. We expect you to formulate your own hypotheses, propose experimental design to address them, and take advantage of the laboratory and research communitys intellectual and skill resources to advance the knowledge of the field. The appointee is expected to publish in top-level international peer reviewed scientific journals. In addition, she/he is also expected to potentially take part on the other research tasks such as ones related to ongoing studies and preparation of grant applications. The specific responsibilities will vary according to the level of expertise of the candidate.

The ideal candidate has an extensive background in standard molecular cell biological methods, ideally encompassing genetic and microscopic techniques and/or bioinformatics (NGS data). Expertise in biochemistry and molecular biology is a pre-requisite for this position. Additional expertise for research projects involving human subjects, primary cell culture would be highly desirable. The ideal candidate is an adaptable team-player and has excellent communication and organizational skills and a strong command in written and spoken English and should be familiar with the constraints related to translational research.

This position will provide multiple opportunities for collaborations with potential lab visits abroad and cross-disciplinary scientific exchange, where the candidate will receive extensive training in cutting-edge technology. An aptitude to drive and maintain intra and inter team collaborations will be highly appreciated. In return, the candidate is offered access to an extensive variety of methodology and advanced techniques, appropriate supervision and help in career development.

More information about the lab, including the latest research and news, can be found here:http://www.jacksonlab.org

The position is initially limited to 2 years with a possibility of extension starting from September 2020. The contract of employment includes a probationary period of 6 months. Salary will be based on the Universities salary scheme for teaching and research personnel composed of both task specific and personal performance components.

The position will remain open until a suitable candidate will be recruited.

Please submit: CV, list of publications, motivation letter including a description of your research interests, and the names and telephone numbers of at least two referees.

Please submit your application, together with the required attachments, through the University of Helsinki electronic recruitment system by clicking on the Apply for job button. Internal applicants (i.e., current employees of the University of Helsinki) submit their applications through the SAP HR portal.

For further information, please contact Christopher B. Jackson, Ph.D., docent:christopher.jackson@helsinki.fi

Due date

31.08.2020 23:59 EEST

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Doctoral Student/Research Assistant in Mitochondrial Biology and Signalling job with UNIVERSITY OF HELSINKI | 218596 - Times Higher Education (THE)

Simpler COVID-19 test could provide results in hours from saliva – University of Wisconsin-Madison

Associate research specialist Miranda Stauss and senior scientist Roger Wiseman process small vials of spit collected from volunteers.

At far right, Tom Friedrich, professor in the UW School of Veterinary Medicine, explains a consent form as his colleague Matt Reynolds, center, assistant professor in the UW School of Veterinary Medicine, hands a volunteer small vial for collecting spit as part of a trial of a new COVID-19 saliva test.

A volunteer spits in a small vial as part of a trial of a new COVID-19 saliva test.

A vial with saliva is processed as part of a trial of a new COVID-19 saliva test.

Wearing an N95 face masks, associate research specialist Miranda Stauss and senior scientist Roger Wiseman process small vials of spit collected from volunteers as part of a trial.

Researchers sort small vials of spit collected from volunteers.

Stauss processes small vials of spit.

Vials of spit are collected from volunteers as part of the trial.

Volunteers at four sites in Madison are being tested for the virus that causes COVID-19 by spitting in a vial, which may prove faster, cheaper and less complicated than other common tests, according to University of WisconsinMadison researchers.

Scientists from UWMadisons AIDS Vaccine Research Laboratory, a team that in recent years has also turned its attention to COVID-19 and Zika virus outbreaks as need arose, have tuned a relatively simple genetic testing process to find evidence of the novel coronavirus in saliva.

With support from a National Institutes of Health grant program that hopes to expand testing in the United States by fall, the researchers have collected hundreds of samples from volunteers at three UWMadison sites and a local elementary school. The tests were completed in hours, a stark contrast to common wait times of several days or even weeks for results from other kinds of COVID-19 tests.

Tom Friedrich, professor in the UW School of Veterinary Medicine, explains a consent form and the process of volunteers spitting in a small vial as part of a trial of a new COVID-19 saliva test.

This sort of testing, if it is successful and can be expanded, offers hope that schools and workplaces could receive rapid turnaround testing to assist in the complex decision of managing education during the outbreak with a test that is still sensitive enough to catch the people who are contagious, but exceptional in terms of accessibility, cost, and turnaround time says David OConnor, professor at the UW School of Medicine and Public Health.

They made their early findings available in late July in a brief study posted on medRxiv, a website for health sciences research that has not yet been peer-reviewed and published in a scientific journal. The test has not been approved for clinical diagnosis. The UWMadison researchers are studying whether this type of test can be administered frequently and efficiently.

Recent studies show that frequent, repeated testing is key to detecting infected people quickly, says Tom Friedrich, professor in the UW School of Veterinary Medicine. Because people can be contagious before they show symptoms of COVID-19, rapid testing can allow them to isolate and protect others before they even realize they are infected.

The project started in February even before the first COVID-19 cases appeared in Madison when OConnor and Friedrich were working with UW Hospital and Clinics to see if recent flu-like illnesses were actually the new virus.

We were interested in knowing whether there was silent spread of the virus in Madison, says OConnor. Fortunately, diagnostic testing became available very quickly. We shifted gears to adapting an alternative type of nucleic acid testing.

Most testing for SARS-CoV-2, the virus that causes COVID-19, uses a chemical process called polymerase chain reaction, or PCR, to make copies of the genetic material in a small sample so they are easier to identify. The Madison group employs a different method, called reverse-transcriptase loop-mediated isothermal amplification (RT-LAMP) to amplify the identifiable parts of virus available in saliva samples.

The advantage of RT-LAMP is that it is easier to set up than PCR, and doesnt require specialized instrumentation, OConnor says. We realized that this sort of testing might be more appropriate for places like workplaces, schools and nursing homes that might require on-site, frequent, repeated testing.

RT-LAMP also uses different chemicals than the PCR process, which has become so vital to pandemic testing that supply chains and manufacturing capacity have been stretched thin. And RT-LAMP requires fewer steps, using simpler and less expensive instrumentation than PCR.

I set up an (RT-LAMP kit) one Saturday afternoon and confirmed that indeed we could do the assay, says AVRL scientist Dawn Dudley. However, it soon became clear that this technique was not as sensitive as PCR especially in its easiest form.

Both PCR and RT-LAMP processes work better if the genetic material the nucleic acids that make up DNA and RNA are separated from the rest of the stuff in saliva, but the simplest version of RT-LAMP skipped that step. David Beebe, a UWMadison pathology professor with experience in putting lab tests on small, reproducible chips, and Salus, the Madison-based spinoff company he helped create in 2013, joined the group to design and produce an extraction process that would work outside lab settings and make the RT-LAMP test much more accurate with a small saliva sample.

Dudley and scientist Christina Newman spent months adapting the test for saliva, because the group expected people would get pretty tired of the common sampling method, a swab (now also in short supply) run sometimes deep into the nose.

Scientists Roger Wiseman and Miranda Stauss process small vials of spit collected from volunteers.

Collection is more comfortable, which is especially important if you are getting tested twice a week and important for children, Dudley says. Swabs can be quite invasive and somewhat damaging over time. Spitting into a tube? Not so bad.

Newman also set up the testing sites including AVRL and the Wisconsin National Primate Research Center where the researchers unload their gear from a minivan twice a week and collect samples across a folding table from as many as 60 people on some days.

Basically, people come, sign the consent, and spit into a tube that is left in a cooler, Dudley says. It takes less than five minutes.

With small groups, processing can be finished, results read via a color change in the test tube and delivered in a matter of hours and probably without a team of lab-trained scientists.

Other groups are also testing the effectiveness of the new test. Chris Mason, a UWMadison alum who is now a professor at Cornell University, is running a trial of his labs LAMP-based test with city workers in Racine, Wisconsin, where the collecting and processing is done mostly by firefighters. Salus is working on a commercial version of the test that can be deployed in small, mobile labs that Newman says could be straightforward enough to be operated by people without lengthy lab science training.

The researchers have run more than 400 tests, finding two positive cases and one that may be a false positive. Each result positive and negative, save the potential false positive has been confirmed laterby checking the saliva sample with the clinical-lab-standard PCR testing. Because the RT-LAMP test is not yet approved for clinical diagnosis of COVID-19 infection, the researchers have UW Hospital and Clinics doctors contact volunteers who tested positive and advise them to get a PCR test as soon as possible.

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Simpler COVID-19 test could provide results in hours from saliva - University of Wisconsin-Madison

The 1st edition of Independent Iraqi Film Festival to kick off from August 21-28 – Egypttoday

File: Independent Iraqi Film Festival.

CAIRO - 7 August 2020: The first edition of Independent Iraqi Film Festival to kick off fromAugust 21-28

This is Iraqs first independent film festival. Iraqi Independent Film Festival (IIFF) is a community-driven platform dedicated to supporting films from and about Iraq, facilitated by four Iraqi volunteers working in the creative industry.

With over 80 submissions from Iraqi filmmakers, the festival programme aims to empower directors, actors, screen- writers, producers, designers, sound artists and other creatives to tell their stories.

Sharing the most exciting work by emerging and established Iraqi filmmakers, the festival aims to showcase the diversity and resilience of our people, as well as the breadth of our culture to a global audience.

The festival will be online and free, featuring shorts programmes, feature films and Q&As.

Our festival opens with Iraqi auteur filmmaker Mohammed Al-Daradjis documentary War, Love, God & Madness (2008).

Like many of Iraqs documentaries, it highlights the difficulty of filmmaking in Iraq and the grassroots nature of the Iraqi film industry.

The film highlights how film teams in the middle of the war overcome violent creative oppression, driven by a passion for cinema so strong that makes it worth risking it all. Also filmed in Baghdad, our second feature screening is Oday Rasheeds Qaran- tina (2010). A subtle and beautifully shot drama that follows the story of a broken family in Baghdad who takes in a mysterious lodger.

Intentional framing leaves the audience tied to the characters with a sense of imprisonment as the events unfold.

Our two other feature films are shot by diasporic filmmakers, exiled from their homeland due to the threat of their creativity as perceived by Iraqs dictatorship at the time. Samirs latest narrative feature Baghdad in my Shadow (2019) is a gripping thriller about Iraqis haunted by their political pasts, set in a fictional Iraqi Communist cafe in the heart of West London.

The screening will be followed by a Q&A with Samir, where we will be discussing how Baghdad is creatively rendered in postcolonial, exilic and Western imagination. Kasim Abids Mirrors of Diaspora (2018) explores themes of exile, creativity and war told through the lives of seven Iraqi artists living outside their homeland for close to half a cen- tury. The central question the film asks: what are the consequences of spending most of ones life in exile? At a time of unprecedented global migration, this documentary sheds a nuanced understanding of one of the defining issues of our time.The first shorts programme in the festival, Tracking Iraq: New Wave Cinema, explores life within Iraq from the vantage points of its diverse communities, as well as the innovative techniques of filmmak- ing throughout the country. Dhyaa Jodas Sabeya (2019) documents a Yazidi woman in the valley ofa mountain in northern Iraq. Hussein Al-Assadis She Was Not Alone (2019) also sheds light on the resilience of rural Iraqi women, documenting an amusing woman living alone in the marshes of south- ern Iraq, who has an interesting way of living with her animals. Conversely, Usaima Alshaibis experi- mental short film Baba Boom Boom (2016) takes us to the heart of the city, where we listen to folkloric music from Iraq performed by Alshaibis characterful father and meditate on the rich oral traditions within Iraqi culture. Haidar Jehads Talking Heads (2016) takes us to Basra, where it sheds light on the ambitions and desires of young men as they dream of a better life.

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The 1st edition of Independent Iraqi Film Festival to kick off from August 21-28 - Egypttoday

Virtual meetings offer tips, strategies to cope with Covid-19 – thelandonline.com

HAMPTON, Iowa Sometimes too much of a good thing can be stressful. Due to the continuing Covid-19 pandemic, couples and families may be facing a surplus of quality time. So what can couples do to manage all of this togetherness?

Iowa State University Extension and Outreach will be providing a series of short virtual meetings over eight weeks with information and suggestions to help couples thrive in this new reality. The information presented will be based on ELEVATE a relationship education curriculum developed by the National Extension Relationship and Marriage Education Network.

Human sciences specialists and staff with ISU Extension and Outreach will be leading meetings every Wednesday, beginning Aug. 19 through Oct. 7, from 12:30 p.m. to 1 p.m. During each meeting, the specialists will review a different tool couples can immediately use to improve their relationship during this challenging time. Each 30-minute training will be offered through Zoom.

The following topics will be discussed.

Aug. 19: Introduction This session will reinforce some things you likely already do for your relationship and learn about and practice new skills which can further enrich the quality of your relationship.

Aug. 26: Empower By taking care of your physical, emotional and spiritual needs, you can better care for the relationship with your partner.

Sept. 2: Lay the Foundation Relationships require nourishing in a consistent and conscientious manner. Even during COVID-19 challenges, what makes the difference are the intentional choices each partner in the relationship makes every day.

Sept. 9: Enlighten Being enlightened requires couples to be in the know with each other. This is an ongoing process.

Sept. 16: Value Showing you value your partner means you focus on the positives of your partner and the relationship. Expressing the positives is like making deposits in your partners emotional 'bank account.'

Sept. 23: Attach Research shows couples who interact in loving ways and maintain these efforts do much better over time in their relationships. Essentially, it is the couple sharing of themselves, with each other, and together that contributes to the wellbeing of their relationship as a couple. Because of COVID-19 many couples are finding they now have more physical time with each other. Couples can use this time to develop a close friendship, nurture positive interactions with each other, build a meaningful sense of couple identity and spend meaningful time in each others presence.

Sept. 30: Tame Its not the conflict thats the problem, its the way the couple manages the conflict that is related to couple satisfaction and stability. How couples manage negative emotions, soothe physiological responses, create positivity in the relationship, accept differences, use forgiveness, adopt a willingness to accept influence, empathize and work together can lead to successful and effective conflict management.

Oct. 7: Engage Being connected is an essential part of a healthy relationship in normal circumstances, but during COVID-19 this need has become even more prominent. During this time couples can learn to draw strength from others, look for meaning and purpose, and reach out to others and their communities, albeit virtually in many cases. In doing so they can help themselves, their relationship, and their communities to be resilient.

To register, visit https://www.extension.iastate.edu/humansciences/elevate. Information about access to a unique Zoom room will be emailed to registered participants prior to each program.

Other resources available include Iowa Concern, offered by ISU Extension and Outreach, provides confidential access to stress counselors and an attorney for legal education, as well as information and referral services for a wide variety of topics. With a toll-free phone number, live chat capabilities and a website, Iowa Concern services are available 24 hours a day, seven days per week at no charge. To reach Iowa Concern, call (800) 447-1985; or visit the website, https://www.extension.iastate.edu/iowaconcern/, to live chat with a stress counselor one-on-one in a secure environment.

211 is a free, comprehensive information and referral line linking Iowa residents to health and human service programs, community services, disaster services and governmental programs. This service is collaborating with the Iowa Department of Public Health to provide confidential assistance, stress counseling, education and referral services related to Covid-19 concerns.

This article was submitted by Iowa State University Extension and Outreach.

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Virtual meetings offer tips, strategies to cope with Covid-19 - thelandonline.com

Governor Whitmer signs executive directive recognizing racism as a public health crisis WBKB 11 – WBKB-TV

lANSING, Mich. Governor Gretchen Whitmer has signed Executive Order 2020-163, which creates the Black Leadership Advisory Council. The governor also signed Executive Directive 2020-9, recognizing racism as a public health crisis and taking initial steps to address it within state government. Under the Executive Directive, the governor asked MDHHS to make health equity a major goal, as well as required implicit bias training for all state employees.

Since I was sworn in as governor, I have made it a top priority to include more people of color, more women, and more members of the LGBTQ+ community at the table. Weve been able to build a more inclusive state government, but there is more work to do, said Whitmer.

The COVID-19 pandemic has revealed, confirmed, and highlighted the deadly nature of pre-existing inequities caused by systemic racism. For example, in cases where race and ethnicity is known, the rate of reported COVID-19 cases for Black/African American Michigan residents is 14,703 per 1,000,000, compared with 4,160 per 1,000,000 for white residents, more than three times higher. And the rate of reported COVID-19 deaths for Black/African American Michigan residents is 1,624 per 1,000,000 compared with 399 per 1,000,000 for White residents, more than four times higher.

These past several months have been difficult for all of us, but they have been especially tough for Black and Brown people who for generations have battled the harms caused by a system steeped in persistent inequalities. These are the same inequities that have motivated so many Americans of every background to confront the legacy of systemic racism that has been a stain on our state and nation from the beginning, said Lt. Governor Garlin Gilchrist II. That is why, today, we take the much-needed and long-overdue step ofrecognizing racism as a public health crisis. It is only after we have fully defined the injustice that we can begin to take steps to replace it with a greater system of justice that enables all Michiganders to pursue their fullest dreams and potential.

The Black Leadership Advisory Council will be included among a set of diverse ethnic commissions within the state of Michigan. Although African Americans are the largest racial minority in the state, this Council is the first of its kind in Michigan to elevate Black leaders and representatives.

The Council will act in an advisory capacity to the governor and develop, review, and recommend policies and actions designed to eradicate and prevent discrimination and racial inequity in Michigan. To accomplish this goal, the Council is charged with:

During my time as a state legislator, it has struck me as odd that no ethnic commission existed for Michigans largest minority population in our state the Black community. Working with a diverse group of people from across our diaspora, my colleagues and I last month introduced Senate Bill 1034 to create such a commission housed within the Michigan Department of Civil Rights, but it was sadly sent to the Senate Committee on Government Operations to languish, Senator Erika Geiss said. Governor Whitmer recognizes the importance of this issue as well and has taken executive action to create the Black Leadership Advisory Council, which I am proud to support. I look forward to seeing this commission come to fruition and ensuring its statutory status as with other ethnic commissions, so that our state can continue to tackle the issues that impact our Black brothers and sisters long into the future.

Housed within the Michigan Department of Labor and Economic Opportunity, the Black Leadership Advisory Council will consist of 16 voting members representing Black leadership in economics, public policy, health and wellness, technology, the environment, agriculture, arts and culture, and more. It will also product an annual report on its activities.

The negative impacts of racism have put the lives of countless people of color at risk. To this day, racism perpetuates inequitable outcomes in the criminal justice system, achievement gaps in education, disproportionate results in health and infant mortality, and job and housing discrimination. Governor Whitmer joined the American Public Health Association, the American Medical Association, the American Academy of Pediatrics, and the American College of Emergency Physicians in declaring institutional racism an urgent public health issue.

Executive Directive 2020-9 directs MDHHS to work with other state departments to examine data, develop and plan policies, and engage, communicate and advocate for communities of color. The governor has directed that all state employees be required to take implicit bias training to understand the unconscious preferences we experience without intentional control and how it can impact others. The training is required for existing employees and must be completed within 60 days for newly hired employees.

Implicit, unconscious bias exists within each of us, and as public servants we have a duty to understand how our bias can impact the lives of others, said Governor Whitmer. I am committed to leading by example and making sure state government is a model for equality, understanding, and fairness.

Under Executive Directive 2020-9, data documenting differences in health outcomes among racial and ethnic groups in Michigan must be collected, analyzed, and made publicly available to help leaders implement equitable policies. Additionally, departments must understand how racial disparities in societal, environmental, and behavioral factors intersect to affect access to resources like good jobs, access to healthy and affordable food and housing, equitable transportation options, and quality public education.

The Michigan Coronavirus Task Force on Racial Disparities will work in partnership with departments to develop a plan that details how Michigan will eliminate the root causes of the inequities that cause disparities in health outcomes for our residents.

MDHHS has introduced an Equity Impact Assessment (EIA) tool to help prevent implicit bias from affecting the policies and practices the department develops to serve the community. The EIA guides leaders to think through the full implications of their decisions on minority populations and is proven to decrease systematic disparities and inequities in marginalized populations.

To apply to the Black Leadership Advisory Council visit Michigan.gov/appointments and click Black Leaders Advisory Council from the drop menu of the application. Applications are due by Wednesday, August 19th.

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Governor Whitmer signs executive directive recognizing racism as a public health crisis WBKB 11 - WBKB-TV

In the face of COVID-19, cell and gene therapy space shows ‘remarkable resilience:’ report – FierceBiotech

In the early days of COVID-19, the Alliance for Regenerative Medicine (ARM) was unsure how the pandemic and its accompanying economic downturn would affect the cell and gene therapy space.

It was a really specific time when the world and the markets were clearly reeling from the first appreciation for the seriousness of COVID-19, Janet Lambert, the organizations CEO said.

Now, the numbers are inand theyre better than ever. In the first half of 2020, the regenerative medicine sector raised $10.7 billion, more than the total capital raised in 2019 and a 120% jump over the first half of 2019, ARM found in a new report titled, Innovation in the Time of COVID-19. The proceeds were shared pretty evenly between cell therapy companies ($7.5 billion) and gene and gene-modified cell therapy companies ($7.9 billion), with companies focused on tissue engineering reeling in $84 million.

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RELATED: Biotech IPO bonanza: Legend's $350M offering as Repare, Forma get in on the action

That $10.7 billion was driven by a couple of outsize deals and includes $1.4 billion raised in five IPOs, $1.6 billion in follow-on offerings and $3 billion in venture capital. Chinese CAR-T player Legend Biotech led the pack with its mammoth $487 million Wall Street debut in June, but its peers netted considerable sums too. That same month, gene therapy companies Generation Bio and Akouos raised $230 million and $244 million, respectively. In February, another gene therapy outfit, Passage Bio, raised $284 million and gene-editing biotech Beam Therapeutics bagged $207 million.

On the venture side, Sana Biotechnology scored $700 millionalmost as much as the five next largest private rounds raised by Orca Bio Elevate Bio, Legend, Freeline Therapeutics and Poseida, the report found. Like Legend, Generation Bio and Akouos also completed sizable private rounds the same year they went public.

RELATED: 'The silver lining': Biotech IPOs in the time of coronavirus

All this enthusiasm for this sector right now is evidenced by these really astonishing financing numbers I think the drivers of that enthusiasm remain in place and make me optimistic for the second half of 2020, Lambert said. We continue to see really promising clinical results. We continue to see products making it to market. We continue to see patient, regulator and payer enthusiasm for these products.

Part of that enthusiasm stems from an appreciation for the biotech sector generally, Lambert said.

Attention is being paid to what the biopharma sector can do for us all as we try to weather and get out of the pandemic, she said, echoing the sentiments of venture capitalists whove managed to raise life sciences funds in spite of the pandemic.

The other side of the equation is the nature of biotechbecause the drug development cycle is long, biotech investors arent looking for quarter-to-quarter returns, but at milestone readouts that can come more than a year after IPO, Jordan Saxe, head of healthcare listings at Nasdaq, said in a previous interview.

Biotech is actually fairly well positioned to weather these kinds of events because youre not relying on day-to-day consumer spending. Youre relying on meaningful clinical catalysts at the end of the day to really generate value, and thats still going to be there in this environment, said Jason Pitts, Ph.D., a principal at Sofinnova, in ARMs report.

RELATED: Flagship raises $1.1B to create biotechs for post-pandemic world

All this gas in the tank isnt just bankrolling existing cell and gene therapies, but also driving company formation, Lambert said. For the first time, ARM counts more than 1,000 companies working in the sector, with more than 1,000 clinical trials going on worldwide. More than half of those studies are in phase 2, with just over a third in phase 1 and the remainder in phase 3.

Of those studies, 11 are testing regenerative medicine approaches against COVID-19, with several academic research centers and biopharma companies working on new treatments to treat the disease in the short and long term.

Most of them are using cell therapies to address ARDS, or acute respiratory distress syndrome, which is a consequence of COVID-19, Lambert said. Unlike other prospects in the pipeline, such as antibodies, which could potentially be used to prevent infection as well as treat it, regenerative treatments focus on repairing damage to the lungs or other organs that patients can suffer as part of COVID-19.

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In the face of COVID-19, cell and gene therapy space shows 'remarkable resilience:' report - FierceBiotech

Gene Therapy Promising in BCG-Unresponsive Bladder Cancer – Medscape

More than half the patients with high-grade bacillus Calmette-Gurin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC) treated with nadofaragene firadenovec (Instiladrin), an investigational intravesical viral gene therapy, achieved a clinical response at 3 months in a phase3 trial.

The results "provide a significant efficacy benefit that, pending regulatory approval, might offer patients with a difficult-to-treat bladder cancer a bladder-sparing alternative," said Neal Shore, MD, medical director for the Carolina Urologic Research Center in Myrtle Beach, South Carolina.

There is clearly an unmet need for new bladder-sparing treatments in these patients, said Fred Witjes, MD, from the Radboud Institute for Molecular Life Science in Nijmegen, the Netherlands, who discussed trial findings during the virtual European Association of Urology 2020 Congress.

"The drugs that we have are old and there is a limited availability for both MMC [mitomycin-C] and BCG. We need some alternatives for initial adjuvant therapy," he explained. "The unmet need is, of course, especially there in BCG-unresponsive patients or BCG-unresponsive CIS [carcinoma insitu]."

"Clinically appropriate patients with BCG-unresponsive NMIBC are currently faced with radical cystectomy," Shore explained during his presentation at the congress.

Nadofaragene firadenovec is a viral-based gene therapy that consists of a replication-deficient adenovirus that delivers the gene for interferon alpha-2b (IFN2b). When administered with the polyamide compound Syn3, the viral vector can deliver the IFN2b gene to the epithelial lining of the bladder. The gene is subsequently incorporated into cellular DNA, meaning that large amounts of the IFN2b protein can be produced locally.

For their open-label, randomized trial, Shore and his colleagues looked at 157 patients with a mean age around70 years. All participants had carcinoma insitu or high-grade Ta (noninvasive) or T1 (invasive) papillary disease with or without carcinoma insitu, and all had been unresponsive to standard intravesical treatment with BCG in the previous 12 months.

Nadofaragene firadenovec was administered once every 3 months, for up to four doses in the first year. If patients showed no signs of high-grade disease recurrence at 12 months, they were offered continued treatment.

For patients with high-grade carcinoma insitu, the complete response rate was 53.4% at 3 months and 24.3% at 12 months. For patients with papillary tumors, the response rate was 73.0% at 3 months and 44% at 12 months.

The majority of study participants (72%) received two or three courses of BCG overall; that rate was 68.3% for those with carcinoma insitu and 80.0% for those with papillary disease. Just over half the patients with carcinoma insitu were refractory to BCG, as were 70% of those with papillary disease.

Almost one third of patients will not respond to BCG, and more than 50% will experience recurrence and progression during long-term follow-up, according to results from the phase2 study of nadofaragene firadenovec, which Shore was involved in.

In that trial of 40 patients, the response rate was 30% at 12 months for those with carcinoma insitu, and durable responses were seen out to 36 months. Investigators reported no dose-limiting toxicities or immune toxicity.

In the phase3 study, treatment-emergent adverse events were experienced by 93% of participants, but the vast majority were transient and grade1 or 2 events; approximately 17% were grade3. There was one grade4 event, but this was not related to the study treatment.

The most common treatment-emergent adverse events were instillation-site discharge, reported by 33.1% of the patients; fatigue, reported by 23.6%; bladder spasm, reported by 19.7%; micturition urgency, reported by 17.8%; and hematuria, reported by 16.6%.

"Follow-up and treatment of these patients is ongoing in an extension study," Shore said.

"We do really need something new in nonmuscle invasive bladder cancer," Witjes observed. "There has to be an alternative to cystectomy and, fortunately, news is coming."

"There is a highly unmet need, but we have to realize that there is a lot in the pipeline," he explained. "We have trials with immune checkpoint blockade, vaccines, genetic therapy, and drug-delivery systems."

Nadofaragene firadenovec creates "adaptive immunity that may be lifelong," Witjes reported. "Instiladrin has a good basis, has consistent, good results, and it has a good safety profile. In light of current developments, I think this certainly is an interesting option."

The study was sponsored by FKD Therapies Oy and conducted in collaboration with the Society of Urologic Oncology Clinical Trials Consortium. Shore reports receiving research and consulting fees from Amgen, Astellas, Bayer, BMS, Dendreon, Fergene, Ferring, Janssen, Merck, Myovant, Nymox, Pacific Edge, Nucleix, Pfizer, Sanofi-Genzyme, Sun Pharma, and Tolmar. Witjtes reports receiving advisory or lecturer fees from multiple companies, but none relevant to his comments.

European Association of Urology (EAU) 2020 Congress. Presented July17, 2020.

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Gene Therapy Promising in BCG-Unresponsive Bladder Cancer - Medscape