Category Archives: Genetic Engineering

NEW YORK, Jan. 06, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, provided an update today from the ongoing Phase 1 clinical trial of INB-200, an autologous DeltEx drug resistant immunotherapy (DRI). DeltEx DRI consists of gamma-delta T cells that have been genetically engineered to be chemotherapy resistant, allowing them to be administered concurrently with alkylating chemotherapeutic agents, including temozolomide (TMZ). This clinical trial, conducted in patients newly diagnosed with glioblastoma multiforme (GBM), is the first and most clinically advanced trial to use genetically modified gamma-delta T cells and includes a multi-dose escalation regimen.

Cohort 1 accrual and treatment is complete with three patients having received a single dose of DeltEx DRI via intracranial infusion concurrent with maintenance TMZ administration. Cohort 2 is currently recruiting and treating patients, with one patient having completed all three doses administered intracranially at 28-day intervals concurrent with maintenance TMZ. The Phase 1 clinical trial of INB-200 (NCT04165941) and the progress reported here constitute the first single- and multiple-dosed patients with genetically modified gamma-delta T cells in any indication.

INB-200 has had a manageable safety profile in all four patients treated to date, with no DLTs, CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) or treatment-related serious adverse events (SAEs). The data to-date indicate promising PFS and OS, which will continue to be assessed on an on-going basis, with additional data anticipated at medical meetings later this year along with comprehensive biological correlative data.

Patients with GBM have poor prognoses with a median survival of 14.6 to 16.6 months and PFS of approximately 4 to 6.9 months. The data reported today suggest that INB-200 may have the potential to extend both progression-free and overall survival compared with standard-of-care in the front-line setting, said Trishna Goswami, MD, Chief Medical Officer at IN8bio. We believe that the combination of our DRI technology and the potential to administer multiple doses of INB-200 could lead to improved efficacy results by making our gamma-delta T cells resistant to chemotherapy induced cell death, potentially permitting prolonged and more efficient tumor killing. This approach may overcome the limited efficacy observed in clinical trials of other cellular therapies in patients with solid tumors.

We are pleased to see that INB-200 has continued to be well-tolerated in both the single and multiple-dose treated patients to-date, said principal investigator, L. Burt Nabors, MD at the ONeal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB). GBM is one of the most difficult cancers to treat, with an urgent need for new therapies. One of the significant hurdles to the use of cellular therapies in solid tumors is the impact of chemotherapies on immune cells, which has been uniquely addressed in the engineering of the DeltEx DRI cells.

Four patients have been treated to-date. In cohort 1, all have exceeded their expected PFS interval, with an encouraging trend in OS based on standard-of-care for their respective age and methylguanine-DNA methyltransferase (MGMT) status1-3. One of these patients remains alive at 17 months post-treatment, having exceeded their expected PFS and OS. As previously reported, a second patient survived for 15.6 months, with a PFS of 8.3 months, and died from an unrelated medical event without further progression. The third patient in cohort 1 exceeded predicted PFS and died at 9.6 months due to progression. In cohort 2, the first patient to complete all three doses has stable disease at 6.9 months and remains in follow-up. An earlier patient enrolled in cohort 2 completed two doses of INB-200 but died due to an acute cardio-pulmonary event without further disease progression. This was reviewed by the data safety monitoring board (DSMB) and the FDA who deemed the event unlikely to be related to therapy, and the study was allowed to continue uninterrupted. Neither patient dosed in cohort 2 experienced any infusion reactions, CRS, DLTs, or ICANS. Patient recruitment and treatment are ongoing with anticipated completion of enrollment in 2022.

INB-200 is an investigator initiated, open-label Phase 1 clinical trial evaluating IN8bios DeltEx DRI therapy in newly diagnosed GBM patients. Patients in cohort 1 received a single dose of INB-200, while patients in cohort 2 receive three doses at 28-day intervals and patients in cohort 3 are planned to receive six doses at 28-day intervals. All doses are given concurrently with maintenance TMZ and are intended to eliminate residual cancer during the vulnerable period of chemotherapy-induced tumor injury, when immune stress ligand expression is upregulated. The primary endpoints of this Phase 1 trial are safety and tolerability, with secondary endpoints based on biologic response, progression free and overall survival.

References1 NEJM 2005;352:987-996. DOI: 10.1056/NEJMoa0433302 NEJM 2005;352997-1003. DOI: 10.1056/NEJMoa0433313 NEJM 2017;376:1027-1037 DOI: 10.1056/NEJMoa1611977

About IN8bioIN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue.

The proprietary IN8bio DeltEx platform is designed to overcome many of the challenges associated with the expansion, genetic engineering, and scalable manufacturing of gamma-delta T cells. The DeltEx platform employs allogeneic, autologous, and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells. This approach allows us to expand the cells ex vivo to administer a potentially therapeutic dose to patients, harnessing the unique properties of gamma-delta T cells, including their ability to broadly recognize cellular stress signals on tumor cells. We have used the DeltEx platform to create our deep pipeline of innovative allogeneic, autologous and/or genetically modified product candidates designed to effectively target and potentially eradicate disease and improve patient outcomes.

IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.

For more information about IN8bio and its programs, please visitwww.IN8bio.com.

Forward Looking StatementsCertain statements herein concerning the Companys future expectations, plans and prospects, including without limitation, the Companys current expectations regarding the advancement of its product candidates through preclinical studies and clinical trials and the prospects for such candidates and underlying technology, including the ability of INB-200 to treat GBM, constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The use of words such as may, might, will, should, expect, plan, anticipate, believe, estimate, project, intend, future, potential, or continue, the negative of these and other similar expressions are intended to identify such forward looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Companys control. Consequently, actual future results may differ materially from the anticipated results expressed in such statements. Specific risks which could cause actual results to differ materially from the Companys current expectations include: scientific, regulatory, technical and clinical developments; failure to demonstrate safety, tolerability and efficacy; final and quality controlled verification of data and the related analyses; expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration; the impact of the ongoing COVID-19 pandemic on the Companys clinical trials; and the Companys reliance on third parties, including licensors and clinical research organizations. Do not place undue reliance on any forward-looking statements included herein, which speak only as of the date hereof and which the Company is under no obligation to update or revise as a result of any event, circumstances or otherwise, unless required by applicable law.

ContactsIN8bio, Inc.Charles Butler+1 646.600.6GDT (6438)cbutler@IN8bio.com

Investors:Solebury TroutDavid Buck+ 1 646.378.2927dbuck@soleburytrout.com

Media:Burns McClellan, Inc.Robert Flamm, Ph.D. / Katie Larchrflamm@burnsmc.com/klarch@burnsmc.com

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IN8bio Announces Clinical Updates from the Phase 1 Clinical Trial of its Genetically Modified Gamma-Delta T Cell Therapy in Newly Diagnosed...

An agile attorney-general should be anticipating online challenges. Van Badhams QAnon and On dives down the rabbit hole of conspiracy theories and finds more than a few mad hatters. An Ugly Truth: Inside Facebooks Battle for Domination, by US journalists Sheera Frenkel and Cecilia Kang, investigates the misbehaviour of the worlds largest social network eerily anticipating the recent revelations of whistle-blower Frances Haugen.

For an outlook on the Australian economy, John Edwards Reconstruction and Ross Garnauts Reset paint starkly different pictures. Edwards is sanguine about the strength of the economy in the 2010s, and optimistic about the future, provided we can repair relations with China. Garnaut is pessimistic, noting that from 2013 to 2019, Australias output per person grew more slowly than Japan. Edwards would have the Treasurer make some tweaks; Garnaut believes a transformation is required.

Far be it from me to tell the Minister for Women what to read, but in a year when thousands marched to protest against sexual harassment, I found a plethora of insights in new books by women who have served in the House of Representatives.

Julia Banks detailed the culture of the Liberal Party in her book.Credit:Simon Schluter

In Power Play, Julia Banks details the culture of the modern Liberal Party, drawing insights from her experiences in corporate Australia. In Enough Is Enough, Jenny Macklin and Kate Thwaites reflect on the Labor Party and how it has evolved. In Sex, Lies and Question Time, Kate Ellis interviews women from across the political spectrum and offers a suite of reforms that would improve the culture of Parliament.

As Curtin knew, a great education isnt just about imparting facts but building understanding and a deep love of learning. My English teacher, Judith Anderson, might not have approved but John McWhorters Nine Nasty Words brings the talent of a great linguist to the topic of profanity. Did you know that our taboo swear words have evolved from religion to bodily functions to identity groups? Its f---ing fascinating.

And what maths student couldnt be captivated by Jordan Ellenbergs Shape: The Hidden Geometry of Absolutely Everything? In our family, it led to a lively dinner table debate over one of Ellenbergs quirky questions: how many holes are there in a pair of pants one, two or three?

Finally, if the Education Minister wants a sophisticated analysis of academic freedom in universities, Carolyn Evans and Adrienne Stones Open Minds is it.

This year, the author who has most shaped how I think about the world is Cal Newport. Over the past two decades, Newport has evolved from writing advice books for students (How to Be a High School Superstar, How to Win at College) to writing advice books for professionals seeking to make an impact on the world (So Good They Cant Ignore You, Deep Work) to critiquing the way that social media and email are undermining our ability to truly connect with our friends and produce high-quality work.

His latest books, Digital Minimalism and A World Without Email, go beyond advice to critique the systems themselves. The next productivity revolution, Newport says, will come from companies that free their employees from multitasking madness and create space for people to do great uninterrupted work.

Im yet to fully implement Newports philosophy, but Im excited by its implications. Social media has its place, but a full life also involves bushwalks and picnics, craft projects and ocean swims. Living well also means books glorious books that enrich our souls, challenge our beliefs, and help us empathise with people in different times and places. What Curtin missed in formal education, he made up by immersing himself in books for the rest of his life. Leaders should be readers, and a life of books is a life well lived.

Andrew Leigh is a member of the Australian Parliament. His most recent book, Whats the Worst That Could Happen? Existential Risk and Extreme Politics, is published by MIT Press.

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What books should our leaders be reading ... and why - Sydney Morning Herald

Writing in Applied Physics Reviews the researchers outlined how silk's unique and versatile properties present many possibilities for future technologies in the food supply chain both as a crop booster and a food protective coating.

Silk has recently come to the forefront of sustainability research. It is made in nature and can be reprocessed from recycled or discarded clothing and other textiles.

Silk fibroin is an ideal candidate as a method to preserve crop freshness, minimize food loss and ensure food safety, said author Giulia Guidetti. Once applied as a coating, it is edible, tasteless, odourless, transparent, biodegradable, and possesses outstanding mechanical properties as well as low permeability to oxygen and water vapours.

"We are continuing to improve the integration between different disciplines," she continued. "For example, we can use silk as a biomedical device for drug delivery but also include an optical response in that same device. This same process could be used someday in the food supply chain. Imagine having a coating which preserves the food but also tells you when the food is spoiled."

In a 2016 Tuftsstudy, silk fibroin was applied as an edible coating on strawberries and bananas by dipping the fruits in a silk fibroin suspension. The coatings were able to extend the shelf life of both kinds of fruit, decreasing the respiration rate, weight loss, water vapor and oxygen diffusion, preserving firmness and colour, and delaying ripening of bananas compared to uncoated control during 14 and 9days of storage for strawberries and bananas, respectively.

Silk's use has also been investigated as a crop booster. In this context, silk fibroin was used in combination with sugar additive trehalose to develop a seed coating that boosted seed germination and mitigated abiotic stressors by encapsulating, preserving, and releasing biofertilizers in the soil.

However, a few challenges remain unsolved and partially hinder silk's use as a ubiquitous material both at the laboratory scale and at the industrial level, cautioned the researchers.

Silk is versatile and often superior to more traditional materials, because it can be easily chemically modified and tuned for certain properties or assembled into a specific form depending on its final use. However, controlling and optimizing these aspects depends on understanding the material's origin.

The bottom-up assembly of silk by silkworms has been studied for a long time, but a full picture of its construction is still lacking. The team emphasized the importance of understanding these processes, because it could allow them to fabricate the material more effectively and with more control over the final function.

"One big challenge is that nature is very good at doing things, like making silk, but it covers an enormous dimensional parameter space," said author Fiorenzo Omenetto. "For technology, we want to make something with repeatability, which requires being able to control a process that has inherent variability and has been perfected over thousands of years."

As with all natural materials, the silk fibroins is dependent on environmental factors. This will require the development of dedicated, monitored, and automated large-scale production approaches to mitigate batch to batch variability, external contaminants, and environmental influence, explained Guidetti.

Genetic engineering techniques could help to achieve higher protein yields, she added, ultimately leading to silk proteins with new capabilities and, in the future, more economically competitive products. Genome editing, indeed, could enable the advancement of silk-based devices with finely tuned physicochemical properties along with advanced functionalities, wrote Guidetti, while broadening the manufacturing capacity as a result of a robust control on genomic sequence, protein size, and homogeneity, as well as degradation rate, thereby generating responsive materials.

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Silk lauded as future solution in food waste and preservation - FoodNavigator.com

Who rules and how they rule, manage people and economies, is cause for deep global concern but those who create, innovate and invent are the opposite theyre cause for great delight and optimism. That about sums up Ivo Vegters outlook for 2022 in the Daily Friend which initially invokes depression and a sinking heart but dont stop reading; its ultimately uplifting and hopeful. From America and the UKs bumbling leaders to China and Russias expansionist ambitions, the world is full of dangerous, cunning, greedy and/or clumsy presidents and prime ministers. Yet it has an equal share of amazingly creative people (a disproportionate number South African-born) transforming earth and space travel, energy and communication and solving problems and creating stuff in nano seconds, using artificial intelligence. Were all living longer, (until some despot leader goes too far), healthier and more virus-resistant lives thanks to ground-breaking bio-medical developments, and we have more economic freedom the list goes on. Pick your view the glass is either half empty or half full; your happiness quotient probably depends on it. Chris Bateman

By Ivo Vegter*

Every new year, I try to write a piece to remind us (and perhaps reassure myself) of reasons for being satisfied with the present and remaining optimistic for the future. It isnt always easy.

Reasons to be pessimistic I can recite at length.

Russia will likely invade the Ukraine this year, as Vladimir Putin continues to flex his tsarist ambitions. The North Atlantic Treaty Organisation (NATO) will wag fingers and scold Vlad the Great, but beyond sanctions it will do nothing. And Vlad the Impalers territorial hunger will not end with the Ukraine.

China will probably invade Taiwan, taking advantage of the geopolitical instability created by its northern neighbour. Once again, the West will feign outrage, but be unwilling to get into a shooting war over what is essentially a large microchip factory. After all, they might as well buy those chips from Red China. Chinas territorial ambitions will not end there, either.

So, on a geopolitical level, the world appears to be getting more dangerous.

In South Africa, someone just waltzed into Parliament and set the joint on fire. Nobody cared enough to make sure the place was guarded, or that the sprinkler system worked.

All economic indicators continue to point in the wrong direction. Unemployment is unsustainably high, and still rising. The number of working municipalities is dwindling. The number of functional SOEs is at or near zero. Government debt to GDP has turned exponential.

President Cyril Ramaphosas new dawn has been a damp squib;as I wrote days after his installation as president: Cyril Ramaphosa will not be South Africas saviour. He will lead it further into the mire of socialism. It is easy to oppose evil that blatantly appears to be evil. Even a child can do that. The far more dangerous evil is that committed by a person who is intelligent and well-educated, who appears well-meaning, and who expresses his intentions with charm and charisma. That, in essence, is the difference between Jacob Zuma and Cyril Ramaphosa.

As expected, he had neither the political strength, nor the appetite, for sweeping action against corruption. A few scapegoats will be hanged in the town square, perhaps, but the majority of the ANC will march on hopefully to defeat at the hands of the electorate.

In the third quarter of last year, GDP was the same as it was in the first quarter of 2016, meaning that in the last five and a half years, South Africa has achieved zero GDP growth.

Yet inflation is higher than it was before the pandemic, at 5.5%. Food inflation runs even higher. The fuel price is astronomical, having broken the R20/litre barrier. Electricity tariffs are going through the roof, while 2021 was the worst year for blackouts yet.

South Africa has one of the highest tax burdens in Africa and in the world, which is why nobody wants to invest here, and people with the ability to do so are fleeing the country in droves.

Those of us who arent leaving are getting poorer.

Business confidence has been dismal since 2008, and although it has recovered from the lockdown lows, it remains at about half of what it was at the height of the Mbeki era.

Consumer confidence likewise has recovered from its pandemic dip, but remains negative. After a brief spike of excitement when Saint Cyril became our daddy, consumer confidence has returned to levels last seen in the darkest days of the Zuma administration.

Violent protest and lawlessness is on the rise; the police powerless against it. Trust in the government is at an all-time low.

Worldwide, central banks are printing more money than ever before, and government officials are shocked (shocked!) that inflation is no longer confined to pushing up the value of the properties and stocks that they own, but is starting to run out of control in consumer prices, too. (Buy Bitcoin, if youre not shocked.)

The rampant crony-capitalism of the green technology sector is making vast new fortunes for investors, but at the cost of spiralling energy prices for consumers.

Meanwhile, popular movements are pushing to redirect trillions into futile efforts to modify the climate, instead of allowing poor countries to get prosperous so they can pay for weatherproofing just like rich countries do.

Politically, both the left and the right are getting more radical.

A new generation with no memory of the deadly legacy of socialism is openly calling for a new era of socialism, and clamouring for governments to save us from everything from bad language to bad weather.

A new generation with no memory of the catastrophic consequences of xenophobia and protectionism is calling for a new era of right-wing nationalism, and clamouring for governments to save us from everything from hard-working immigrants to hard-working foreigners.

The choice the younger generation offers us is not one of freedom versus tyranny, its which tyranny you prefer.

Nowhere is this political divide more clear than in the idiocracy that elected first a clown and then a dotard to its highest office. Whos next? Oprah Winfrey? Alex Jones? Alexandria Ocasio-Cortez? Marjorie Taylor Greene? Dr. Oz? Milo Yiannopoulos? Ken Ham? The ghost of Bernie Sanders?

This is the country that invented jazz and where people fly to space for fun, but they cannot find a remotely competent and respectable person to place in high office.

And I havent even scratched the surface of reasons to be pessimistic. At leastbeing pessimistic can be good for you.

Yet, while the future looks bleak, it probably isnt. There are many reasons to remain optimistic, even in the face of inevitable setbacks.

Out of the pandemic comes the first reason: mRNA vaccines. These things are awesome.

Vaccines were already among the wonders of 20thcentury medicine. Along with antibiotics, sanitation and clean drinking water, they have been instrumental in the dramatic decline in death and suffering from infectious disease, and save millions of lives every year.

Now, the idea that you can simply script a vaccine to produce whatever proteins you want, is ground-breaking. Instead of taking months or years to develop, this technology reduces the speed of vaccine development to days or hours. Already, the platform is being turned towards previously intractable diseases such as rabies, influenza, malaria, Zika, HIV and cancer.

This will revolutionise preventative healthcare in the 21stcentury, albeit only for the smart people who are in favour of preventing disease. I expect theres a Nobel Prize in it, probably forKatalin Karik and Drew Weissman(andnot for Robert Malone).

More broadly, genetic engineering is earning a place in the sun. Gene therapy is already proving to be successful in treating a range of diseases, and the ability to edit geneswill change everything, forever.

Even more broadly than biotechnology, the march of technology has not slowed down, as many had fearedas Moores Lawbeginsto reach its physical limits. Just the other day, we witnessed the launch of a long-delayed, heavily over-budget new space telescope. It is a glorious piece of engineering that promises amazing insights and will dethrone Hubble as the desktop wallpaper-maker of choice.

Elon Musk, for all his obnoxious personality, is doing amazing things at SpaceX, finally revitalising a sector that has been unproductive and mismanaged by governments since the end of the Apollo programme.

The promise of a commercial space industry, ranging from tourism to scientific research to exploration to mining extraterrestrial resources, is huge.

Musk is also in the vanguard although followed by many competitors in the electric vehicle market, which will, eventually, revolutionise transport for all of us, and have spin-off benefits for an all-electric future.

The internet really came to the party during the pandemic, dragging reluctant technophobes into the brave new world of video conferencing and instant messaging.

Dont be put off by Zuckerbergs creepy metaverse vision. Dont be put off by the Chinese Communist Partys global surveillance network, TikTok, which becamethe most-visited website in the worldin 2021, beating the Five Eyes global surveillance network, Google.

The early internet was also a shitshow of walled gardens, animated gifs, unencrypted network connections, viruses and trojans. Somehow, smart people tamed it and made it work for everyone.

Ubiquitous computing power, ubiquitous high-speed connectivity, ever-evolving artificial intelligence, and robotics, while scary at times, will continue to change our lives, as the internet and smartphones have done in only a few short decades.

Up until the pandemic broke out,economic freedomwas, on average, rising in the world:

There will undoubtedly be a dip as a result of the draconian lockdowns, but the long-term trend should revert to the mean in due course.

The reason this is important is that economic freedom correlates strongly and I believe causally with a host of indicators of wellbeing, including higher income per capita, a higher income share for the poor, a higher nominal income level for the poor, lower poverty rates, improved life expectancy, reduced infant mortality rates, higher school enrolment, a higher score on the UN World Happiness Index, better gender equality, and improved environmental performance.

Although the UNs Intergovernmental Panel on Climate Change persists with its apocalyptic warnings, itsmost scary predictions are also the most unlikely. Contrary to the alarming images in the news, natural disasters used to be far more deadly than they are today:

That economic freedom is on the rise is alsogood news for the climate. In contrast with government-led top-down control (such as the measures imposed to deal with Covid-19),free markets are the best and fastest wayto address the challenges posed by a changing climate.

And although the nuclear fission industry has been hamstrung by irrational public fears and dishonest but successful lobbying by its competitors both in fossil fuels and renewable energy, there is growingexcitement about, and investment in, nuclear fusion, which if successful will be transformational for both civilisation and the environment.

Thanks to the pandemic, global death rates have increased, and thanks to the lockdowns imposed in a vain attempt to slow the pandemic down,half a billion people have been thrust into extreme poverty. This is a great tragedy. However, the pandemic response did not kill the poverty-eradication project. It merelysetitback bya decade or so. It need not be a long-term catastrophe, unless we accede to a new normal of socialist redistribution,or a Great Reset.

Although things might look grim, todays circumstances are not uniquely dreadful. In fact, they remain better than living conditions have been for the vast majority of human history.

If we steadfastly continue to advocate for private and secure technology, public accountability, classically liberal political principles and free markets, the long arc of human development will continue tomake the world a better place.

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How we view the world Ivo Vegter - BizNews

I spent part of my workday on Wednesday watching a rerun. It was of a Virtual Town Hall meeting entitled Gene Editing: The Future of the Produce Industry?, by the Produce Marketing Association BB #:153708, originally broadcast July 28.

PMA broadcast it again because of its popularity.

It answered one of the proverbial dumb questions that journalists, if no one else, should ask. In this case, whats the difference between genetic engineering and gene editing?

A rigorous answer to this question would depend on your location because various nations define (and regulate) the two differently.

This is essentially the difference: if an organism has been modified by the insertion of foreign DNA, its genetically modified (a GMO, for short).

Gene editing, on the other hand, is modifying genes in a way that could be achieved by plant breeding, except gene editing takes much less time. (For details, see here).

The United States regulates the two methods differently.

USDA issued this statement in March 2018: USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests. This includes a set of new techniques that are increasingly being used by plant breeders to produce new plant varieties that are indistinguishable from those developed through traditional breeding methods.

As an example of gene editing, panelist Haven Baker, cofounder and chief business officer of Pairwise, points to one of his companys current projects: the pitless cherry.

With conventional breeding, it would take 150 years, he remarks. But his company is three years into the project. He predicts that pitless cherries will be on the market by the end of the decade.

Seedless blackberries are further along: Baker estimates they will be available in a couple of years.

Another item: a watermelon that produces a natural zero-calorie sweetener, which panelist Fayaz Khazi, CEO of Bio Life Systems, says is producing to scale now.

Gene editing, panelist Gilad Gershon, CEO of Tropic Biosciences, says, is very specific. You maybe only change one nutrient, or disease resistance.

One example is TR4 Fusarium wilt, which afflicts Cavendish bananas and, if not checked, can destroy the world banana industry as it is now known.

We try to identify genes that affect Fusarium resistance, and try to fit them to consumer needs, Khazi says.

The panel kept returning to one major theme: the importance of consumer wants in gene editing crops. We try not to guess what the market needs, stresses Khazi.

Indeed, the disconnect between real and perceived consumer needs is the biggest bottleneck, Khazi adds. Surprisingly, the biology of the plant is never the bottleneck.

Currently, no produce items are on the market in this country that are products of gene editing, the panelists noted, although Japan has introduced a tomato with a high GABA content that is available there.

Eventually, Khazi predicts, the two categories of GMO and gene editing will merge.

In any case, gene editing is part of the produce industrys present and will become an increasingly important element of its future. Think of it as plant breeding on fast forward.

And never forget to ask dumb questions.

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Editing the produce gene - Produce Blue Book

The UAE the most-vaccinated country in the world against Covid-19 has approved another vaccine from Chinas Sinopharm, to be used as a booster.

As reported in The National, the Ministry of Health and Prevention gave emergency approval this week for the recombinant protein-based vaccine before a roll-out set to begin next month.

State news agency Wam said that clinical trials in the Emirates showed the vaccine stimulated an immune response and did not result in side effects.

Among those involved in the trials were people who had previously received two doses of the Sinopharm inactivated vaccine, which has been widely used in the Emirates.

Here we take a look at the new Sinopharm shot.

The UAE has approved a new vaccine to be used as a booster for anyone who has received two doses of Sinopharm. Pawan Singh / The National

The word recombinant refers to the fact that genetic engineering has been used to produce the new Sinopharm vaccine.

Typically this involves genetic material from the pathogen being inserted into the genetic material of another organism, such as a yeast or a bacterium.

This causes the genetically engineered organism to produce, in this case, coronavirus proteins, which are extracted and purified, and included as part of the active ingredient of the vaccine.

When the vaccine is injected, the immune system recognises the coronavirus proteins -which are antigens as foreign and responds by producing antibodies and other substances to use against them.

If the vaccine recipient is subsequently infected with the coronavirus, the earlier immune response to the vaccine means the immune system is prepared and should be better able to mount a defence against the pathogen.

Unlike messenger RNA (mRNA) vaccines, such as the Moderna and Pfizer-BioNTech shots, recombinant protein-based vaccines were already being given to people before the coronavirus emerged.

The first vaccine based on recombinant DNA methods was one against Hepatitis B, that was approved by the US Food and Drug Administration in 1986.

For this vaccine, the antigen is produced by yeast cells that have had genes for the Hepatitis B surface antigen (HbsAg) inserted into their genetic material.

Some influenza (flu) vaccines are also produced using recombinant technology.

In this case, host cells produce haemagglutinin, an influenza surface protein.

There are other, older forms of technology used to produce vaccines. Inactivated vaccines, for example, have been used for more than a century.

These are often created by producing large numbers of virus particles before they are inactivated with chemicals, heat or radiation. The vaccine may contain the whole virus or just components of it.

Recombinant protein-based vaccines have been extremely useful and extremely innovative, according to Prof John Oxford, emeritus professor of virology at Queen Mary University of London and co-author of the textbook Human Virology.

Ive got nothing but admiration for the whole technology, he said.

Ive got respect for Sinopharm and the other companies in China. Theyre well established.

He added that it was good that vaccines based on several types of technology including mRNA vaccines, inactivated vaccines and recombinant protein-based vaccines, among others had been produced to combat Covid-19.

We dont know all the ins and outs of these different vaccines against Covid, he said.

Some may produce a quick immune response, some a slow immune response.

Some [may produce a] very broad [response], including T cells [a type of immune cell] as well as B cells [which produce antibodies], others a slow but longer-lived response. There are so many variations on the theme. Until the playing field levels, we will not be able to see which is best.

Some influenza (flu) vaccines are also produced using recombinant technology. PA

Sinopharm, the trading name of China National Pharmaceutical Group Corporation (CNPGC), has been one of the key producers of Covid-19 vaccines.

It has two inactivated Covid-19 vaccines, one of which, BBIBP-CorV (sometimes written simply as BIBP), was assessed during clinical trials in the UAE and other countries.

With this vaccine, large numbers of coronavirus particles are produced using vero cells, a type of lab-grown cell line, before the virus particles are rendered harmless or inactivated by chemical treatment.

Many people in the UAE who received this vaccine in the UAE were subsequently given a dose of the Pfizer-BioNTech mRNA vaccine as a booster.

In April media reported that China National Biotec Group Company, a Sinopharm subsidiary, had received approval to begin human trials of its protein-based coronavirus vaccine.

Five months later, in September, Sinopharm unveiled four second-generation Covid-19 vaccines designed to be more effective against the Beta and Delta coronavirus variants.

These four vaccines were of three types: inactivated virus, mRNA and recombinant protein-based, the last of which is the technology behind the vaccine being rolled out in the UAE.

Hayat Biotech is a joint venture between Sinopharm and G42, an Abu Dhabi-based technology company. Photo: G42 Healthcare

As reported in The National, the new Sinopharm vaccine, which will be used from January 2022, is being produced by Hayat Biotech.

Hayat Biotech Hayat is the Arabic word for life is a joint venture between Sinopharm and G42, an Abu Dhabi-based technology company.

In 2020 G42 teamed up with Sinopharm to help administer clinical trials of the BBIBP-CorV vaccine in the UAE.

The two companies joint venture this year began production of BBIBP-CorV in the UAE under the name Hayat-Vax. This made the UAE the first Arab nation to manufacture Covid-19 shots.

Production started in a pharmaceutical plant in Ras Al Khaimah run by Gulf Pharmaceutical Industries PSC (Julphar), before the expected transfer to a new Hayat Biotech facility in Abu Dhabi capable of producing 200 million doses per year.

Updated: December 29th 2021, 3:00 AM

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What is the new UAE-approved Sinopharm vaccine and how does it work? - The National

A researcher in the Madurai Kamaraj University (MKU) has come up with a diagnostic kit to detect COVID-19 infection in 12 seconds. The kit has been patented in India and the researcher has applied for patent at Geneva as well.

T. Arokiyadoss, Assistant Professor and in-charge head of the Department of Physics at the Directorate of Distance Education, developed the diagnostic kit based on lab-on-a-chip technology.

The research team included B. Ashokkumar, Associate Professor, Genetic Engineering Department, and P. Varalakshmi, Assistant Professor in the Molecular Microbiology Department in the School of Biotechnology. The then Vice-Chancellor of the university, M. Krishnan, partly funded the research.

The RT-PCR kit requires 30 minutes to do the test. Our kit can perform the same in just 12 seconds. The kit directly interacts with the virus. When the virus enters the body, it attaches itself to ACE2 (antigen converting enzyme 2) and multiplies. Out kit takes the mRNA from the virus, amplifies and quantifies the virus, explained Mr. Arokiyadoss.

The researchers then sought the support of Madurai Medical College officials, including the then Dean J. Shangumani, and the colleges Viral Research and Diagnostic Laboratory, Institute of Microbiology, to test the kit. The college formed an ethical clearance board to approve the proposal.

We took 200 swab samples from COVID-19 infected patients to assess the performance of the kit. We were given 3 ml from the sample while another 3 ml went for the RT-PCR test. The results from both kits were similar, he said.

Mr. Arokiyadoss filed for a patent for his technology in India as well as in Patent Cooperation Treaty (PCT), Geneva. The PCT patent is pending approval. He has now signed an agreement with a Hyderabad-based private company that makes molecular diagnostics kits for manufacture and commercialisation of the device.

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Madurai Kamaraj University researcher develops kit to diagnose COVID-19 in 12 seconds - The Hindu

GAITHERSBURG, Md. and PUNE, India, Dec. 28, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announcedthat the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The vaccine will be manufactured and marketed in India by SII under the brand name Covovax.

"No one is safe until everyone is safe, and today's authorization marks a vital step for India, where additional vaccine options and millions of doses are needed in the country's ongoing efforts to control the pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Novavax and SII will not rest in our partnership to deliver our vaccine to those in India and across the globe, as we work to protect the health of people everywhere."

Because the vaccine is stored with standard refrigeration at 2 to 8 Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas.

"The approval of Covovax in India marks a significant milestonein strengthening our immunization efforts across India and LMICs," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "We are proud to deliver a protein-based COVID-19 vaccine, based on Phase 3 clinical data demonstrating more than 90% efficacy and a favorable safety profile, to our nation."

The Novavax/SII vaccine recently received EUA inIndonesiaand the Philippines, as well as Emergency Use Listing (EUL) with theWorld Health Organization(WHO). Novavax was also granted Conditional Marketing Authorization by the European Commission and EUL with the WHO for its vaccine, which will be marketed by Novavax as NuvaxovidTM. Novavax has also announced regulatory filings for its vaccine in multiple countries worldwide, while partners SK bioscience and Takeda have submitted regulatory filings inSouth Koreaand Japan, respectively.Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

For additional information on Covovax, please visit the following websites in the coming days:

Authorized Use of Novavax' Covid-19 Vaccine in India

The Drugs Controller General of India (DCGI) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcgto induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.

Authorization in the U.S.

NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. FDA.

Important Safety Information

Covovax is contraindicated in persons who have hypersensitivity to the active substance or to any of the excipients of this vaccine.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. The current assigned shelf-life of the vaccine is 9 months.

Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide.

About the NVX-CoV2373 Phase 3 trials

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.

A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in theNew England Journal of Medicine(NEJM).

PREVENT-19, a trial in the U.S. andMexico, with 25,452 participants, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response in both studies. Full results of the trial were published inNEJM.

About Matrix-M Adjuvant

Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19 vaccine, received Conditional Marketing Authorization from the European Commission, Emergency Use Listing from the World Health Organization, Emergency Use Authorization inIndia, Indonesiaandthe Philippines, and has been submitted for regulatory authorization in multiple markets globally. NanoFlu, the company's quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Novavax is currently evaluating a COVID-NanoFlu combination vaccine in a Phase 1/2 clinical trial, which combines the company's NVX-CoV2373 and NanoFlu vaccine candidates. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visitwww.novavax.comand connect with us on Twitter,LinkedIn, Instagram and Facebook.

About Serum Institute of India Pvt. Ltd.

Driven by the philanthropic philosophy of affordable vaccines,Serum Institute of India Pvt, Ltd.is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses), supplying the world's least expensive and WHO-accredited vaccines to as many as 170 countries. It was founded in 1966 with the aim of manufacturing lifesaving immunobiological drugs including vaccines worldwide. With a strong commitment towards global health, the institute's objective has been proliferated by bringing down the prices of newer vaccines such as such as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. SII is credited with bringing world-class technology toIndia, through its state-of-the-art equipped multifunctional production facility in Manjari,Pune; association with Zipline and government agencies to transform emergency medicine and critical care along with spearheading the race of vaccine development against the COVID-19 pandemic.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373 and its partnerships, the scope, timing and outcome of future regulatory filings and actions, the role that COVOVAX may play in helping to increase vaccination rates and to control the COVID-19 pandemic in India and across the globe, Novavax' and SII's continued efforts to deliver COVOVAX to those in India and across the globe, and COVOVAX's potential to increase vaccination access in hard-to-reach areas are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov and http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors

Novavax, Inc.

Erika Schultz | 240-268-2022

ir@novavax.com

Solebury Trout

Alexandra Roy | 617-221-9197

aroy@soleburytrout.com

Media

Ali Chartan | 240-720-7804

Laura Keenan Lindsey | 202-709-7521

media@novavax.com

Serum Institute of India

Mayank Sen | +919867974055

mayank.sen@seruminstitute.com

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Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India - KPVI News 6

In the Charles Dickens novel A Christmas Carol, Ebenezer Scrooges final transformation from miser to philanthropist is marked by the big juicy turkey that he orders for the struggling Cratchit family and which has inspired Christmas menus across Britain and North America ever since.

A family-sized turkey with all the trimmings, including mashed potatoes and stuffing, made for an impressive Christmas dinner centrepiece in Victorian households. Turkeys were also largely within economic reach for those on modest incomes compared with the grander cuts of venison and beef enjoyed by the upper classes meaning festive feasting could be celebrated by all.

Depending on your own personal traditions, it might be hard to imagine Christmas without a turkey. Yet festive menus in the UK looked very different before the 19th century. They often included a variety of meats, cakes and liquors, and there was little to distinguish Christmas food from that of other celebrations and holidays.

Two hundred years on from the Dickensian turkey boom, it seems our festive favourites might be due for another radical rethink. Slaughter-free meat and soilless vegetables are just some of the innovations that are predicted to revolutionise food production. Many of these technologies have emerged in response to turbulent times for traditional agriculture.

In the UK, turkey farmers are currently battling Brexit and COVID disruptions, plus a highly contagious outbreak of avian flu. Globally, meat and dairy producers face mounting pressures from the climate crisis, rising antimicrobial resistance and the growing popularity of plant-based alternatives. Even Christmas vegetables are threatened by drought, floods and the loss of agricultural land to soil erosion.

Weve watched enough sci-fi films to know that predicting exactly what the future will look like is a pretty futile task. Instead, weve served up a menu of possible food futures based on technologies that are currently in development.

According to culinary historian Cathy Kaufman, one of the legacies of A Christmas Carol was an awful slaughter of Christmas turkeys. Now, slaughter-free meat also known as cultured or cultivated meat is under development.

This approach uses animal cells to grow flesh outside the body in bioreactors (artificial systems supporting biological environments). Techniques like precision fermentation and genetic engineering are also being used to reprogramme yeast and bacteria cells to create cow-free milk and chicken-free eggs.

Cell-cultured turkeys probably wont be at the centre of Christmas tables for some time. The first cultured meat product to hit the market was a hybrid chicken nugget, made of a mixture of cultured cells and plant-based ingredients, in 2020. But we dont yet have the technical ability to create the more complex structures of larger joints of meat, though a lot of money is currently being thrown at this challenge.

Were already growing some of our fruit and veg in artificial, sustainable environments using soil-free hydroponic farms its a safe bet that the tomatoes in your fridge were grown hydroponically. This trend is set to continue, with brassicas like broccoli and Brussels sprouts now being grown without soil.

Yet many uncertainties remain over whether these technologies will be able to compete with industrial livestock production, or to deliver on the environmental and ethical leaps their advocates have promised.

Hybrid meat substitutes can offer meaty tastes and textures with a potentially smaller environmental footprint than conventional animal-based products. For a festive example, think hybrid pigs in blankets made from cultured pork and fat cells with added soy or pea proteins.

Hybrid products like these represent incremental steps in meat reduction rather than an immediate radical overhaul of the food system. Yet whether they provide a gateway for a long-term shift away from meat, or simply add to consumers options, remains to be seen.

If theres an overall reduction of meat production and consumption across the worlds biggest meat-eating nations like the UK and US, then high-quality real meat from smaller, climate-conscious producers could be reserved for celebratory occasions like Christmas. For the rest of the year, we could follow a menu of plant-based foods and meat alternatives. But a key challenge is whether people are willing to reduce meat to this extent.

The turkey dinner is, of course, only one version of many seasonal menus enjoyed by different cultures around the world meaning that we dont necessarily have to follow its formula when imagining future Christmas feasts.

We might be dining on insect-based Christmas pies with robot-harvested algae on the side, consuming festive-flavoured nutrient drinks, or eating imitation meats made from air-fed microbes.

Alternatively, we might ultimately reject conventional meat and ultra-processed protein products and embrace a meatless menu of vegetables and legumes as already enjoyed in some Christmas traditions across the world.

Many of these scenarios have far-reaching implications for the future of food and farming from changing agricultural livelihoods and landscapes, to deciding which industries are in control of our food systems.

While turkeys may vote for many of these options, its important to understand who else is set to benefit or lose in each case and what other solutions might be missing from the table. Change in food systems is nothing new. Considering how that change is made is, however, essential if we are to serve up the most sustainable and equitable futures for all.

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What will your Christmas dinner look like in 2050? - The Conversation UK

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