Scientists captured video of a rare squid with tentacles as long as a human – Business Insider – Business Insider

The squid was dragging long, spaghetti-like tentacles and using fins like elephant ears to propel itself through the dark waters.

Marine scientist Deborah Osterhage spotted it in footage collected from cameras on remotely operated vehicles that had scoured Australia's Great Bight a bay off the continent's southern coast. The creature was swimming 2 miles under the surface.

"I recognized it immediately, with its distinctive large fins and extremely long and slender arms and tentacles, which were bent a little like an elbow," Osterhage told Business Insider.

The animal was a bigfin squid, or magnapinnidae: a camera-shy cephalopod rarely seen by humans. It had never been spotted in Australian waters before.

In a study published last week in the journal PLOS One, Osterhage and her team describe how they captured footage of five of these rare squid in Australia, and what the sightings reveal about the creatures' anatomy.

The videos enabled the researchers to make an unprecedentedly accurate measurement of the squid's body and tentacles.

"The fact that they have been rarely observed makes these sightings very special. Up until now, only around a dozen have been filmed over a period of 30 years, so seeing five in the Great Australian Bight is very exciting," Osterhage said.

Osterhage's team, part of Australia's Commonwealth Scientific and Industrial Research Organization, wasn't specifically looking for bigfin squid. They were simply trying collect footage of the Bight's thousands of marine species by towing underwater cameras behind a research vessel.

Then two squid showed up in the footage.

So the team organized a second voyage to the Bight, this time using remotely operated vehicles (ROVs). That way, they could better control what the cameras filmed and pause if they found a species on their "critter hotlist," Osterhage said.

That research revealed three more bigfin squid.

Although the encounters lasted only minutes, that was long enough for the researchers to measure one of the animals using two laser pointers mounted on the ROV. It measured more than 5.9 feet (1.8 meters) long, with its body making up just 6 inches of that total.

"The arms and tentacles were around 11 times the mantle length, which is not what is typically seen in squid," Osterhage said.

By contrast, the giant squid has a mantle, or body, around 8 feet (2.5 meters) with tentacles four times that length.

A bigfin squid missing three tentacles seen in the waters of the Great Bight. Courtesy of Deborah Osterhage/CSIRO

Bigfin squid get their name from the bulbous fins that jut out from their bodies. The fins are about as wide as the body is long, according to Osterhage. But it's the body-to-tentacle proportion that makes these squid unique.

Another neat feature: the squid like to flex.

Most cephalopods' tentacles dangle below their mantles, but a bigfin's bend that's why Osterhage was able to spot the animal so easily in the footage.

All told, Osterhage's team collected 40 hours of underwater footage at depths between 0.6 miles and 2 miles (946 meters and 3,258 meters).

The five squid were all spotted in about the same place: "They were clustered in close proximity of each other in time and space," Osterhage said.

The study authors confirmed, though, that they'd seen five different squid, not the same one. That was a deviation from previous sightings, which had mostly involved individual squid.

"Clustering like this could indicate habitat preference, a gathering for reproduction, or even effects of currents," Osterhage said, adding, "further sightings will help us figure out this puzzle."

Bigfin squid filmed by underwater cameras in Australia's Great Bight. Courtesy of Deborah Osterhage/CSIRO

Given the paucity of bigfin squid sightings, researchers still don't know how they reproduce or feed none have deigned to nosh on camera.

"Because their long arms and tentacles are retractable and sticky, some scientists believe they may use them to 'fish' for their food, possibly plankton," Osterholm said.

French scientists reported the first-ever bigfin sighting nearly 120 years ago, when a fisherman caught one near the Azores. The squid weren't caught on camera in their deep-sea habitat until 1988, when researchers encountered one 2.9 miles underwater, off Brazil's northern coast.

A bigfin squid spotted on the ocean floor of the Great Bight, more than a mile below the surface. Courtesy of Deborah Osterhage/CSIRO

According to Osterhage, the squid can be found at depths of more than 3 miles. So far, they've been spotted in the southern Caribbean,Indian Ocean, Gulf of Mexico, Pacific Ocean near Hawaii, and off the shores of western Africa.

Of the 12 or so bigfin squid ever seen, the largest was 23 feet (7 meters) long.

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Scientists captured video of a rare squid with tentacles as long as a human - Business Insider - Business Insider

How the IVF lab influences the chance of implantation after embryo transfer – ESHRE

A well attended online Campus meeting in November considered implantation from clinical, embryological and endometrial perspectives, but also focused on the day-to-day working of the IVF lab.

An online Campus meeting in November, with more than 250 remotely registered, reviewed the latest on successful and failed implantation from the perspectives of the meetings three organising SIGs (Embryology, Stem Cells and Implantation & Early Pregnancy). But what was also high on the meetings agenda were the effects which everyday laboratory practices might have on the fate of the embryo after transfer.

Barcelona embryologist Gemma Arroyo noted chromosomal testing and culture conditions as prominent factors but also added quality management systems, lab design and location, ambient conditions (lighting, air quality), biosecurity and culture equipment as important in the optimisation of embryo viability. For example, air conditioning, she said, should have air recycling at least 15 times per hour, with control of circulating particles and air pressure.(1) Similarly, she advised that oxygen concentrations during incubation would affect outcome, noting a Cochrane review supporting embryo culture with low oxygen concentrations for improved success rates in IVF and ICSI.(2) However, a recent study in which oxygen levels were reduced from 5% (low) to 2% (ultra low) found no added benefit.(3) Similarly, fluctuations in pH concentrations have been evident in blastulation rate reduction and alterations in gene expression (raised pH) and in fetal weight (lower pH).

While the introduction of time-lapse systems has allowed labs to maintain consistent and controlled culture environments, no such consistency is yet evident in the culture media single-step or sequential - behind the huge global shift to blastocyst transfer. Arroyo described several studies meta-analyses and RCTs reflecting inconsistent comparative results in blastulation and outcome. For example, a systematic review performed by ESHREs SIG Embryology co-ordinator Ioannis Sfontouris and colleagues found insufficient evidence to identify either one as superior, despite the practical advantages of single-step and higher blastocyst formation rates.(4) Similarly, Ubaldis group in Rome found no differences in cumulative delivery rates between the two approaches.(5)

While acknowledging the no-touch stability which time-lapse systems provide, Arroyo nevertheless recommended that their routine adoption should remain an experimental strategy. She noted that no single morphokinetic parameter has so far been consistently shown to predict implantation - indeed, with considerable disagreement over which parameters are even useful, normal or abnormal. This echoed the conclusions of ESHREs recent recommendations on time-lapse, that a clear clinical benefit of its use, an increase in IVF success rates, remains to be proven.(6) However, as the recommendations also noted, hopes of an outcome advantage are not lost.

So, as Ioannis Sfontouris asked of the lab, are we better than nature? Well, nature is certainly not perfect, as Johannes Ott emphasised before his presentation on routine office hysteroscopy before IVF. Citing a recent meta-analysis, he reported that reproductive failure is more common than success, and that embryo quality is implicated in many of these failures.(7) So is embryo culture, and notably extended culture, responsible for compromising embryo quality, asked Sfontouris. He reviewed the pros and cons of embryo transfer from day 1 to day 7 and concluded that, despite the potential for extended culture to trigger epigenetic changes, blastocyst transfer is associated with a higher pregnancy and live birth in the fresh cycle (though similar rates in cumulative cycles), a shorter time to pregnancy, and a more pronounced benefit in good-prognosis patients (while poor prognosis patients may benefit from cleavage-stage transfer.

Abha Maheshwari from the Aberdeen Fertility Centre in Scotland also found a distinction between the effect of ovarian stimulation in the fresh and frozen cycle, indicating that supraphysiological estrogen doses may affect implantation via the uterus. Describing ovarian stimulation as the most important thing in ART, and recognising the shift in defined success from pregnancy per cycle to cumulative healthy delivery, she urged the need of a very delicate balance between generating an adequate number of eggs while not impairing uterine receptivity.

1. Mortimer D, Cohen J, Mortimer ST, et al. Cairo consensus on the IVF laboratory environment and air quality: report of an expert meeting. Reprod Biomed Online 2018; 36: 658-674. doi:10.1016/j.rbmo.2018.02.005.2. Bontekoe S, Mantikou E, van Wely M, et al. Low oxygen concentrations for embryo culture in assisted reproductive technologies. Cochrane Database Syst Re 2012; CD008950. doi:10.1002/14651858.CD008950.pub2.3. De Munck D, Janssens R, Segers I, et al. Influence of ultra-low oxygen (2%) tension on in-vitro human embryo development. Hum Reprod 2019; 34: 228-234. doi:10.1093/humrep/dey370.4. Sfontouris IA, Martins WP, Nastri CO, et al. Blastocyst culture using single versus sequential media in clinical IVF: a systematic review and meta-analysis of randomized controlled trials. J Assist Reprod Genet 2016; 33: 12611272. doi:10.1007/s10815-016-0774-5.5. Cimadomo D, Scarica C, Maggiulli R, et al. Continuous embryo culture elicits higher blastulation but similar cumulative delivery rates than sequential: a large prospective study. J Assist Reprod Genet 2018; 35: 1329-1338. doi:10.1007/s10815-018-1195-4.6. ESHRE working group on time-lapse technology. Good practice recommendations for the use of time-lapse technology. Hum Reprod Open 2020; 2: doi.org/10.1093/hropen/hoaa0086. Craciunas L, Gallos I, Chu J, et al. Conventional and modern markers of endometrial receptivity: a systematic review and meta-analysis. Hum Reprod Update 2019; 25: 202-223. doi:10.1093/humupd/dmy044.

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How the IVF lab influences the chance of implantation after embryo transfer - ESHRE

‘It’s a huge source of stress’: Women going abroad for IVF hit out at mixed messages over travel restrictions – TheJournal.ie

THE GOVERNMENTS MIXED messaging on travel abroad has been criticised by people who need to travel overseas for fertility treatment.

Many people choose to travel to elsewhere in Europe for treatment because the process can be thousands of euro cheaper than in Ireland.

However, people are concerned about the impact Covid-19 travel restrictions, and flights being cancelled, could have on their treatment.

Some people are missing appointments or choosing to delay their treatment, but this is not an option for others particularly if age is an issue.

There has also been a lack of clarity on what is deemed essential medical treatment for travel purposes, and how long a person has to restrict their movements for when they return to Ireland after undergoing a medical procedure abroad.

Emma*, who lives in Dublin, began IVF treatment in Prague in the Czech Republic during the week. She said the process of undergoing fertility treatment is stressful enough without the added worry of travel restrictions and lack of clarity on what people should do.

She believes IVF is an essential journey, but said the governments messaging on travel has been lacking.

Im on a few social media groups for people getting IVF and everyone seems really confused.

We are allowed to travel abroad, but what is not clear and seems to be causing a lot of confusion for people, is the phase of restriction of movement.

Do we still have to restrict our movements when returning from treatment? My reading of [the guidelines] would be that if I was an essential worker like a high-level engineer, I would not have to restrict movements coming into Ireland, so is it the same for us?

Emma is currently taking two weeks of unpaid leave from work so she can self-isolate as a precaution.

TheJournal.ie asked Chief Medical Officer Dr Tony Holohan at Thursdays Covid-19 briefing if IVF is deemed an essential medical reason to travel, and how long people should restrict their movements for when they return to Ireland.

He replied: I would hope that anybody in that situation is under the care and direction of a consultant or clinician in this country who would be perfectly well able to understand not just the public health advice, but how it should apply to a particular individual in a particular clinical context.

And if an individual is worried or concerned about what advice they should be following they should speak to their own consultants.

Holohan said clinicians in Ireland will understand and interpret public health advice and provide that to an individual who need individualised advice about their specific circumstances.

So anybody in this situation, who is seeking treatment outside of the country, I would hope thats under the direction of a clinician in this country, to whom they should speak about how best to protect themselves and manage the risks that might arise for them.

Many of the people who undergo fertility treatment abroad, including Emma, are not under the care of a consultant here.

TheJournal.ie sought further clarification from the Department of Health and the Department of Transport on the issue.

A DOH spokesperson said this: Decisions as to what constitutes essential reasons for medical travel have to be judged on an individual clinical basis. If an individual is concerned about what advice they should be following, they should speak to their own consultants.

The governments latest travel advice can be read here.

PCR test

It was confirmed during the week that from midnight on 29 November, under new guidelines, travellers arriving into Ireland from so-called red regions in the EU (most European countries) can move freely once they pass a PCR Covid-19 test five days following their arrival.

This provision will also be available to arrivals from orange regions who may not have availed of a pre-departure test. You can read more about the traffic light system here.

Obviously, the new guidelines this week were welcome but they wont apply to me this time. What Covid brings to everyone is uncertainty and that includes those of us doing IVF, Emma said.

When she has to revisit Prague in a few months, Emma said she will try to get a PCR test when she returns but, even if it is negative, her employers have said she will likely be unable to work as she deals with the public every day so they dont want to take that risk. She works as a contractor and will need to take more unpaid leave.

File photo Source: Shutterstock/Africa Studio

Helen Browne, co-founder of the National Infertility Support and Information Group (NISIG), said other women are in the same position as Emma.

Its very very tough on people at the moment with Covid-19, she told TheJournal.ie.

Browne said some people will want to keep the fact they are undergoing fertility treatment abroad private, but those who are upfront with their boss often have to take unpaid leave.

Some women will be able to use holiday leave, but this isnt always an option.

Its very difficult to get paid leave, the employer will probably say it has to be unpaid leave, rather than giving them paid leave, Browne said.

They have two weeks of wage or salary not given to them, an added expense on top of everything that theyre going through.

Some women who undergo fertility treatment abroad attend a clinic that is linked to a clinic in Ireland, but many do not have a clinician based here.

A lot of them go independently, she said, so they cant consult with a doctor here about what they should do in terms of restricting their movements.

Browne said people want more clarity on the right thing to do.

She said shes aware of women having to stay abroad for longer than they typically would because of reduced flights.

They now have to stay for about a week, rather than two or three days, because of the reduced flights. Theyre actually having to pay more money for accommodation.

Normally if theyre going abroad for a few days, their partner would go with them. But now because the partner cant take a week off, most likely cant take two weeks off, they cant go with them. Its really tough all round, theyre all on their own over there as well.

Time is a factor

Its hard to get an accurate figure of how many people from Ireland travel abroad for fertility treatment each year but its believed to be in the hundreds.

Most people choose to go to the Czech Republic, Browne noted, but others go to countries such as Spain.

She said some people have chosen to delay their treatment but that this is not an option for everyone.

Unfortunately, some people that go abroad for treatments are told that their ovarian reserve is dropping, and they feel now that they can go.

By the time they get a chance to go, theyll have no choice but to go for donor egg. Whereas they would like to have the opportunity of using their own eggs before they embark on donor eggs if they have to.

If somebody said to me, Im 39 now and by the time I get to go Ill be 40, by the time I had my baby, if Im lucky, Ill be 41. Thats two years added on.

The older a woman is when she becomes pregnant, the higher the risk in terms of complications, and many people need more than one round of IVF to become pregnant.

Its a huge undertaking

During IVF, mature eggs are collected from ovaries and fertilised by sperm in a lab. The fertilised egg or eggs are transferred into the uterus.

One full cycle of IVF takes about three weeks, but can take longer. It may take several rounds of IVF sometimes over the course of years and costing tens of thousands of euro for a person to become pregnant, if its successful.

When you decide to do IVF at all its a huge undertaking, physically, emotionally and of course financially, Emma told us.

She said she made the decision to undergo IVF before the Covid-19 pandemic and, over the course of the first lockdown, decided to go abroad for financial reasons.

We decided to do IVF earlier this year but could not get over the cost of it in Ireland. While saving for a house it just seemed completely out of reach financially.

Emma did some research online and joined a number of social media support groups, and found out that Prague seemed to be a place that was affordable and also offered a good medical service.

We knew it would be a risk and would mean I would be travelling alone a lot of the time, but when your heart is set on starting a family, youll push and push until you find a way.

Emma said the Irish government should fund fertility treatment so people like her dont have to travel abroad.

We are a modern country with an advanced healthcare system and so many more people going for IVF. Its just prohibitive in its cost as it stands.

Cancelled flights

Emma was in Prague for her first round of treatment during the week. She said the service was great but the overall experience was stressful.

Ive just had my first trip to Prague to a great clinic there, but the added layer of having to book flights, presuming they werent going to be cancelled, then constantly watching the government advice on international travel and Covid isolation periods was a huge source of stress.

Im back now but I have to take two weeks off work to isolate and thats a tricky thing to do.

Emma is concerned that if increased restrictions are introduced early next year, she may be unable to travel to Prague.

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This is what really worries me. It will be another few months before I go back for the next round of treatment and Im really worried that international travel will be banned, we might be in a strict lockdown or the same thing could be happening in Prague.

What if I have appointments and flights booked and I have to cancel? Its a hugely stressful time as you have to follow strict hormone protocols for this kind of treatment, so Covid is a very unwelcome complication.

Publicly-funded IVF in Ireland

Health Minister Stephen Donnelly spoke about plans for a publicly-funded IVF system in Ireland, as set out in the Programme for Government, in the Dil earlier this month.

This model of care will ensure that infertility issues will be addressed through the public health system at the lowest level of clinical intervention necessary, Donnelly said.

He noted that the plan will comprise three stages, starting in primary care (GPs) and extending into secondary care (regional fertility hubs) and then, where necessary, tertiary care (IVF and other advanced assisted human reproduction (AHR) treatments).

Structured referral pathways will be put in place and patients will be referred onwards for further investigations or treatment as required and as clinically appropriate. It is intended that, in line with available resources, this model of care for infertility will be rolled out on a phased basis over the course of the coming years, Donnelly said.

The implementation of the model of care will help to ensure the provision of safe, effective and accessible infertility services at all levels of the public health system as part of the full range of services available in obstetrics and gynaecology, he added.

Browne believes it will take quite a few years for publicly funded fertility treatment to be available in Ireland making it too late for many people.

She said a part-funded model is more likely where investigations and blood tests may be paid for by the State.

I personally cannot see the model in the UK, or in other countries where they will fund for two or three IVF cycles, here. I dont know, maybe way down the line.

Guidelines in the UK recommend that IVF is offered on the NHS to women under the age of 40 who have not conceived after two years of regular unprotected sex, or who have had 12 cycles of artificial insemination. These women should be offered three full cycles of IVF, the guidelines say.

In women aged 4042 years, the guidelines say they should be offered one full cycle of IVF, once certain criteria is met.

Advice and support can be found on the NISIGs website.

*Emmas name has been changed to protect her identity.

With reporting by Michelle Hennessy

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'It's a huge source of stress': Women going abroad for IVF hit out at mixed messages over travel restrictions - TheJournal.ie

Schistosomiasis and climate change – The BMJ

Giulio A De Leo and colleagues consider the effect of changing climates and human activity on schistosomiasis transmission and potential solutions to contain its spread

In 2014, a group of German and French tourists with no history of travel to tropical or subtropical countries were diagnosed with urogenital schistosomiasis, a debilitating parasitic disease that affects more than 200 million people in South America, Asia, and particularly sub-Saharan Africa. The European Centre for Disease Prevention and Control eventually tracked 120 cases of Schistosoma infection that were acquired in summer 2013 (and seven more, between 2015 and 2016) by people swimming in the Cavu River in Corsica. This French Mediterranean island is a popular summer destination for tourists from all over Europe. Until then, Corsica had been considered outside the geographic range of schistosomiasis transmission because of the near freezing temperatures of inland waters in the winter.

Genetic analyses showed that the parasites isolated in Corsica originated in the lower basin of the Senegal River, where schistosomiasis is hyperendemic. Its temporary establishment on Corsica was thought to have been caused by human movement and subsequent contamination of the river by parasite eggs that established locally in susceptible intermediate host snails and circulated for several seasons.1 Interruption of disease transmission during Corsicas cold winters probably contributed to the natural gradual death of the parasite, and no cases of human schistosomiasis have been reported in the island since 2017. However, a small and short outbreak in this new territory raises concerns about the potential expansion of the range of schistosomiasis as the world becomes warmer.

Schistosomiasis is a tropical and subtropical disease (fig 1) caused by infection with parasitic blood flukes of the genus Schistosoma (fig 2), which use freshwater snails as necessary intermediate hosts. The schistosomiasis pathology results mainly from inflammatory processes caused by parasites eggs in the human body, which may lead to several conditions such as abdominal pain, diarrhea, chronic anemia, cognitive impairment in children, growth stunting, infertility, a higher risk of contracting HIV in women, and death from liver failure or bladder cancer in cases of intense and chronic infection. These effects, combined with poverty and a lack of access to clean water, improved sanitation and hygiene make schistosomiasis one of the worlds most important, but also most neglected, human diseases. The intermediate host snails of schistosome parasites are poikilothermthat is, their body temperature changes depending on the environment. As a result, reproduction, survival, and dispersal are strongly influenced by ambient temperature, as is parasite development inside the snail. Therefore, rising water temperatures and altered precipitation associated with climate change could considerably alter the distribution and abundance of the intermediate host snail and its schistosome parasites, resulting in a shift in disease dynamics and transmission to people. Assessing the impact of global warming and its compounded effect with change in land use are important challenges that will face global health soon.

Schistosomiasis life cycle (central panel) and pathways by which climate change, land use change, agricultural expansion, and development of water management infrastructure may affect disease transmission and human health. The red panels indicate an expected increase in transmission risk for schistosomiasis. The green panels indicate an expected decrease in transmission risk

Predicting the effect of global climate change on schistosomiasis is a complex task,23 because how the disease responds to climate varies with the specific ecology of many different snails and parasite species (table 1) as well as the geographic context that may respond differently to rising temperatures and changes in precipitation (fig 1). We discuss potential effects of climate change on schistosomiasis, its interactions with other determinants of disease transmission, and considerations for schistosomiasis control and elimination in a changing world.

Geographic distribution of schistosomiasis and associated parasite and snail species

The past decade has seen increasing attention paid to the effects of climate change on schistosomiasis in Africa, where an estimated 90% of all human cases are concentrated. Whereas some studies predict that schistosomiasis infection risk may increase by up to 20% in eastern Africa,3 others present a more complex pathogenic landscape, with decreases as well as increases in schistosomiasis transmission risk.24 For example, a continental scale study predicted a 14% reduction in the total geographic area suitable for Schistosoma mansoni transmission in sub-Saharan Africa in 2061-2080 (fig 3a) as temperatures exceed the maximum thermal tolerance for the main intermediate host snail, Biomphalaria pfeifferi.5 However, the same study also showed that other known intermediate host snail species tolerate increasing temperatures better, highlighting the importance of specific snail-parasite ecologies when developing prediction models.5

Top panel: Predicted changes in the risk area for intestinal schistosomiasis transmission in 2061-2080 compared with present baseline in Africa. Blue color indicates predicted shrinking areas as the temperature becomes unsuitable for the intermediate host Biomphalaria pfeifferi (adapted from Stensgaard et al).5 Bottom: Predicted changes in risk area for urogenital schistosomiasis in 2021-2050 compared with present baseline in Africa and Middle East. Suitability ranges from zero (not suitable conditions) to 10 (most suitable). Blue color indicates shrinking areas for schistosomiasis as the temperature becomes unsuitable for the parasite to persist (modified from Yang and Bergquist).6

A similar modeling approach was used to map the predicted change in risk of S. haematobium for 2021-2050.6 The model highlighted potential emerging, as well as contracting, areas in Africa, the Middle East, and southern parts of Europe (fig 3b). A different approach based on data from laboratory and field experiments was used to develop a simulation model to predict the effect of rising temperatures on S haematobium and its intermediate host snail Bulinusglobosus.7 This model predicted that snail abundance and production of cercariaethe free living stage of the parasite shed by infected snailsmay decrease by up to 14% and 8%, respectively, for each 1C rise in ambient temperature. These results agree with the findings of other studies that suitable places for S haematobium in Africa near the equator will decrease under future climatic conditions.2

Yet concern is growing that urogenital schistosomiasis may further expand into areas with colder climates, such as South Africa and the Ethiopian highlands, where the presence of the suitable snail species, lack of access to clean water, and limited or no active surveillance may put an immunologically naive population at risk of infection. Given that many sub-Saharan African countries have limited capacity to adapt to the negative effects of climate change, increased investment in schistosomiasis surveillance and control is a public health priority.

S japonicum occurs in China, the Philippines, and the Indonesian island of Celebes. Unlike the schistosome parasites in the African continent, S japonicum is transmitted through a unique amphibian snail intermediate host, Oncomelania hupensis. Adult parasites can inhabit more than 40 vertebrate definitive hosts, including cattle, goats, water buffalo, and many rodent species; this many reservoir hosts makes control and elimination of schistosomiasis difficult.

Historical data suggest that average monthly temperatures below 0C have prevented northward spread of O hupensis, but climate change is already altering the geographic distribution of schistosomiasis. A study in China found that the 0-1C isothermal zone moved from latitude 3315 N to 3341 N between the 1960s and 1990s, corresponding to a 48km northward shift in just 30 years.8 This shift increased the potential schistosomiasis transmission area by over 40000 km2 with an additional 20.7 million people at risk of infection.

A new transmission risk index has been proposed based on growing degree days for parasites and the snail intermediate host,9 which suggests that S japanicum transmission areas may increase by 662373 km2 by 2030 and by 783883 km2 by 2050 (fig 4). Recent analyses, based on projections from five global circulation models and representative concentration pathway 4.5 scenario in the fifth assessment report of the Intergovernmental Panel on Climate Change, confirmed future northern expansion of schistosomiasis in China by 2100.6 At the same time, these analyses also suggested that the mountainous regions of Sichuan province, where schistosomiasis is currently prevalent, would become unsuitable for snail breeding, thus reducing transmission. However, the areas of the Yangtze River from Sichuan to Hunan and Hubei provinces, a stretch of river affected by the Three Gorges Dam, will still be favorable for snail survival.6

Areas of potential expansion of schistosomiasis (in red) in China, where schistosomiasis is expected to emerge as a result of climate change, and areas where it is currently endemic (in green), elaborated from Zhou et al9

Climate change is also predicted to increase the frequency of extreme climate events, such as droughts, which might reduce the transmission season for schistosomiasis, but also floods, which can locally help the spread of O hupensis snails.10 To track changes in transmission risk for schistosomiasis in China, it will be important to establish early warning systems that report changes in the distribution of the intermediate snail host and possible new cases of human infection.11

Few studies have examined the effect of climate change on schistosomiasis in the American region. Schistosomiasis is endemic to several territories, including Brazil, Dominican Republic, Guadeloupe, Saint Lucia, Suriname, and Venezuela. Most current schistosomiasis infections in the region occur in Brazil, one of the largest tropical countries, the leading dam building nation, and one of the largest agricultural producers in the region.

Climate change is predicted to be particularly severe in some parts of Brazil, including desertification and warming in the northeast of the country,12 where schistosomiasis is endemic. Brazils most populous areas, in the south east, are on the edge of the climate suitability range for the main intermediate host snails, so it is unclear whether more warming in this region could expand the habitat suitable for schistosomiasis transmission.13

Finally, schistosomiasis is traditionally considered a rural disease, but Brazil has many pockets of urban schistosomiasis,14 where population growth has outpaced the ability of development to supply safe water and sanitation. This situation has created a complicated situation where poverty, development, land use, and climate change act together to influence transmission.

The development and management of the infrastructure for water resources, such as dams and canals for hydropower generation, agricultural irrigation, and drinking water, will be important components of societys response to fight climate change and the associated potential water scarcity. Yet, these changes in land use can also increase the risk for schistosomiasis transmission. For instance, to lessen increasingly recurrent droughts in the northern part of China, the South North Water Transfer project has diverted water from the Yangtze River, the current schistosomiasis endemic region, to northern regions, thus increasing the risk of spread of O hupensis northward.8

Dams affect schistosomiasis transmission in many ways (fig 1). More stable water reservoirs inevitably lead to an increase in suitable snail habitat.15 These reservoirs also support growing human settlements and foster expansion of irrigated agriculture and use of fertilizers and herbicides, which have also been shown to increase snail proliferation.16 Dams not only change the habitat for the snails, but also have been shown to block migratory predators17 that have historically kept snail populations in check. The history of the Diama dam in Senegal is a typical example. The dam was built in response to a climatic stress, a severe drought in the western Sahel region in the 1970s. In response, the countries of the region constructed a dam near the mouth of the Senegal River to stabilize flow, prevent saltwater intrusion, support agricultural development, and protect the availability of freshwater for communities. Within a few years of completion of the dam in 1986, and as a result of its construction, the landscape had changed substantially, the African river prawnan effective predator of aquatic snailshad been wiped out, and schistosomiasis transmission had increased so that the lower basin of the Senegal river has become one of the most important regions of the world for schistosomiasis transmission.

In summary, schistosomiasis transmission is expected to decrease in central areas of its current climatic location (that is, tropical Africa), because temperatures will exceed the critical thermal maximum of snails as a result of climate change. Transmission is expected to increase at the margins of the cooler range, where temperatures are currently too low for transmission. Climate change is also expected to affect risk of transmission indirectly through interactions with poverty and rural subsistence livelihoods,18 lack of sewage systems, lack of access to clean water and improved sanitation, lack of affordable healthcare, increasing human movement, dam development, and agricultural expansion.

Therefore, the effect of climate change on schistosomiasis can combine with the effects from land use changes, growing human population, and subsistence livelihoods in unexpected ways. We need new research to reduce the uncertainty associated with potential shifts in the range of schistosomiasis with climate change. While addressing key research questions on climate change and schistosomiasis, decision makers, public health agencies, non-governmental organizations, and communities have several options to prepare for expected shifts in distribution of schistosomiasis caused by the compounded effect of climate and changes in land use.

Integrated surveillance and response systems need to be established in areas where models predict a high likelihood of schistosomiasis becoming endemic. Control strategies, including medical treatment and environmental interventions,19 should be improved in endemic regions where transmission is expected to increase because of climate change, construction of new dams, or agricultural expansion.

Dams built in the historical range of distribution of migratory freshwater prawns, predating the snails involved in schistosomiasis transmission, should now be retrofitted with passages that allow prawns to move upstream and downstream. New dams should be designed with prawn ladders.17 Excessive use of fertilizers should be avoided in endemic regions, and pesticides with minimum effect on natural snail predators should be used instead.20 Although these interventions will not be enough to eliminate schistosomiasis, they may help limit the negative effects of climate change on schistosomiasis transmission.

Invest in research to better understand the likely spread of schistosomiasis with climate change

Establish integrated surveillance-response systems in areas at risk

Increase control strategies, medical treatment, and environmental interventions in endemic regions

Ensure dams allow prawns to move along the river

Control fertilizer and pesticide use in endemic areas

Provenance and peer review: Commissioned; not externally peer reviewed.

Contributors and sources: ASS, GJG and JU have studied and reported widely on schistosomiasis and the related effects of climate change for almost two decades. GADL, SHS, AJC and EKN are involved in a Belmont collaborative project to investigate the effect of climate change on Brazil and Cte dIvoire. This work originated in a SESYNC working group on malaria and climate change led by Mercedes Pascual and Andres Baeza. GADL conceived the idea with JU and then thoroughly discussed it with ASS, SHS and GJY. Each coauthor contributed to a specific section of the manuscript. ASS, GJY and AJC produced the figures. All authors contributed to revise the final version of the manuscript prior to submission. GADL is the guarantor.

Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following: GADL, SHS, and AJC have been partially supported by the Bill & Melinda Gates Foundation OPP1114050, and by the US National Science Foundation (ICER-2024383 and DEB-2011179). SHS and GADL were partially supported by National Science Foundation (CNH grant # 1414102). GADL thanks Rachel Lowe (London School of Hygiene and Tropical Medicine) for making this paper possible. ASS thanks the Knud Hjgaard Foundation for supporting the Platform for Disease Ecology, Health and Climate (grant # 20-11-0483).

This article is part of a series commissioned by The BMJ for the World Innovation Summit for Health (WISH) 2020. The BMJ peer reviewed, edited, and made the decisions to publish. The series, including open access fees, is funded by WISH.

Zheng J, Gu XG, Xu YL, et al. Relationship between the transmission of Schistosomiasis japonica and the construction of the Three Gorge Reservoir. Acta Trop 2002;82:147-56. doi:10.1016/S0001-706X(02)00046-3

Yang GJ, Utzinger J, Lv S, et al. The Regional Network for Asian Schistosomiasis and Other Helminth Zoonoses (RNAS (+)). Target diseases in face of climate change. Adv Parasitol 2010;73:101-35. doi:10.1016/S0065-308X(10)73005-0.

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Christakis’ Book on COVID-19 Featured in the New York Times – The National Herald

NEW YORK Apollo's Arrow: The Profound and Enduring Impact of Coronavirus on the Way We Live by Nicholas A. Christakis offers a riveting account of the impact of the coronavirus pandemic as it swept through the U.S. in 2020, and of how the recovery will unfold in the coming years. The book was featured in the New York Times on November 3, just before news broke of the developments in vaccines from Pfizer and more recently Moderna.

Drawing on momentous (yet dimly remembered) historical epidemics like the 1918 influenza pandemic, contemporary analyses, and cutting-edge research from a range of scientific disciplines, bestselling author, physician, sociologist, and public health expert Christakis explores what it means to live in a time of plague an experience that is paradoxically uncommon to the vast majority of humans who are alive, yet deeply fundamental to our species.

Unleashing new divisions in our society as well as opportunities for cooperation, this 21st-century pandemic has upended our lives in ways that will test, but not vanquish, our already frayed collective culture. Featuring new, provocative arguments and vivid examples ranging across medicine, history, sociology, epidemiology, data science, and genetics, Apollo's Arrow envisions what happens when the great force of a deadly germ meets the enduring reality of our evolved social nature.

The title refers to the arrows, representing plague, that Apollo rained down on the Greeks in Book 1 of the Iliad, the Times reported, noting that the book is a useful contribution to this initial wave of COVID books, sensible and comprehensive, intelligent and well sourced.

Questions about where the virus originated, how it first infected people, and how it is evolving are still being examined by scientists who are trapping wildlife in China, taking fecal samples and blood, culturing viruses, sequencing genomes from bats, pangolins and humans, and comparing them, as the clock ticks, the Times reported.

The National Herald

Apollo's Arrow: The Profound and Enduring Impact of Coronavirus on the Way We Live by Nicholas A. Christakis. (Photo: Amazon)

Apollo's Arrow is a broad survey, not a deep dive, and sweeps across most of the signal topics: the inept early responses to the outbreak, first in China and then in the United States; the back story of modern pandemics and pandemic threats, notably the 1918 influenza and SARS in 2003; the social shutdowns, the mask issue and the tension between civil liberties and public health; the grief, fear and lies that make a pandemic emotionally as well as medically punishing; the social and economic changes, forced by this virus, that may become permanent; the general question of how plagues end and the specific, more speculative question of how this one might, the Times reported.

Since Christakis is a physician and sociologist, the co-author of an earlier book about social networks and how they shape lives, the co-author also of an influential paper on `social contagion theory' and the co-director of the Institute for Network Science at Yale, one naturally expects that `network science' might afford him special insight into COVID-19, the Times reported, adding that this book delivers on that expectation moderately, with a short section on the superspreader phenomenon and such disease-math variables as the basic reproduction number (the average number of persons infected by each infected person in a nave population), the case fatality rate, the threshold for herd immunity and a few others that have become familiar in recent months.

The book also includes dispersion which is the variation in actual (not average) reproduction number from one infected person to another, the Times reported, noting that if some people cause few secondary infections and some cause many, the dispersion is high. The dispersion of COVID-19 is high.

Christakis explains the high dispersion may be partially due to some individuals simply shed more virus, or wash their hands less, or refuse to wear masks or cough more, another contributor to superspreading, but there are also certain people have many more social contacts than the average, the Times reported.

Christakis calls those `popular people,' and notes that they `are more likely to become infected themselves as well as more likely to infect numerous others,' the Times reported, adding that he illustrates this with some dots-and-lines network figures, showing who might have contact with whom.

Although superspreader events in a choir, at a funeral, during a White House reception seem alarming, the existence of high variation in reproduction number for COVID-19 may actually have an ameliorating effect, the Times reported, noting that according to Christakis, it may reduce the threshold for herd immunity, since `popular people' are more likely to get infected early in the pandemic, and most of them will survive, presumably with some immunity.

And if all the popular people became immune early, relatively more paths for the virus to spread through society would be cut off, Christakis writes, the Times reported, adding that that's the good news, but because of its capacity to spread from asymptomatic cases and its relatively low case fatality rate, Christakis estimates, COVID-19 may still infect 40 percent of the global human population, and possibly as much as 60 percent, unless a vaccine becomes available soon.

Christakis also examines the idea that the virus may become less virulent, noting that one way a pandemic can come to an end is that the virus mutates over a period of years to get much milder, the Times reported.

Christakis offers the example of the virus called OC43 is a human coronavirus that causes nothing more severe than the common cold, the Times reported, noting that in fact, along with one other coronavirus, it accounts for as much as 30 percent of all colds, and Christakis cites research suggesting that OC43 spilled into people, from cattle, around 1890, which happened to coincide with the beginning of a severe pandemic that was known as the `Russian flu,' because its first major outbreak occurred in St. Petersburg, in December 1889.

This `flu' swept out of Russia, across Europe, to the United States and much of the rest of the world, as fast as trains and ships could carry it, killing about a million people, the Times reported, noting that Christakis suggests that the 1890 event was a pandemic of OC43, a coronavirus passed to humans from some Russian cow.

After being among us for a century, this virus would have further evolved to be a mild pathogen that just causes the common cold today, Christakis writes, the Times reported, noting that concerning COVID-19 mutating into a milder form, it is still too early to know.

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Christakis' Book on COVID-19 Featured in the New York Times - The National Herald

What Do Inequalities, Covid-19, and International Human Rights Have to Do With Each Other? – Inequality.org

In order to weigh the costs and benefits of protecting and promoting human rights, we must be concrete and articulate. This is evident when we study the impact of health policies on human rights beyond life and physical health. In the face of the medical paradigm which favors the biological aspects and survival of people as a legitimate discourse that influences regulations, practice models, and social representations, another more holistic one emerges. To what extent is it legitimate to forsake freedoms on the altar of a strictly sanitarist vision? International human rights law provides precise guidelines for answering this fundamental question, and this is one of the central points addressed in the new bookCovid-19 and human rights: The pandemic of inequality.

The large economic slowdown, which has exacerbated the economic challenges that several countries in Latin America were already facing in February 2020, has led to an increase in poverty and a decline in economic and social rights. In this context, only elites are capable of resilience in the face of sudden macroeconomic changes. Again we see that, beyond the urgent actions that should be taken to serve the population most affected by the crisis, a transformative agenda needs to be on the discussion table.

Human rights have a scientific, legal, and political purpose. They can shed light on the intricate economic, financial, social, and legal processes that perpetuate inequalities. It is true that the effectiveness of human rights is limited. The levels of poverty and inequalities that exist in the world, and the presidents who suggest taking toxic substances to combat Covid-19 or who recommend not using face masks, without entailing any legal consequences, give us an indication of the impact of human rights in the real world. But this should not lead us to abandon the cause of human rights, but precisely to strengthen its system of protection which, to a large extent, requires reforming the foundations of the prevailing economic system. To this end, it is essential to investigate, report, and denounce the relationships between the pandemic, inequalities, and human rights.

This article first appeared on OpenGlobalRights in English and Spanish on November 6, 2020.

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What Do Inequalities, Covid-19, and International Human Rights Have to Do With Each Other? - Inequality.org

Calypso Biotech Announces Successful Dosing of First Phase 1 Cohort with Anti-Interleukin-15 (IL-15) Monoclonal Antibody CALY-002 for the Treatment of…

Dose-escalation study to evaluate safety, biological and early clinical effect of CALY-002 in healthy volunteers and patients with Celiac Disease and Eosinophilic Esophagitis

AMSTERDAM, The Netherlands, November 16, 2020 / B3C newswire / -- Calypso Biotech, a company developing Interleukin-15-targeted biologics, today announced completion of dosing of first cohort of healthy subjects in the first Phase 1 clinical trial of CALY-002, a novel humanized monoclonal antibody neutralizing IL-15.

CALY-002 is the lead program of our differentiated pipeline of IL-15-targeting biologics, that we plan to investigate in multiple auto-immune diseases. CALY-002 has an unique mode of action which translates into potent biological activity in vivo and is expected to show superior clinical efficacy in patients, says Alain Vicari DVM, PhD, Chief Executive Officer of Calypso Biotech. IL-15 is a key target in auto-immune diseases. IL-15 controls unique immune pathways such as Natural Killer cells and Memory T cells critically involved in disease onset and maintenance, as well as tissue destruction, in addition to its broad effect on inflammation, adds Yolande Chvatchko PhD, Chief Scientific Officer of Calypso Biotech.

Calypso Biotech has elected Celiac Disease and Eosinophilic Esophagitis to evaluate the biological and clinical efficacy of CALY-002. Celiac Disease and Eosinophilic Esophagitis are two diseases with high unmet medical need where IL-15 causes inflammation, and tissue destruction. I am excited that this trial will inform about the safety, pharmacokinetic and pharmacodynamic of single and multiple administrations with CALY-002 in highly relevant populations. comments Josefin-Beate Holz, MD, Chief Medical Officer of Calypso Biotech.

More information on the trial can be found: https://clinicaltrials.gov/ct2/show/NCT04593251

About Celiac Disease and IL-15Celiac Disease is a serious autoimmune disease that occurs in genetically predisposed people where the ingestion of gluten, a protein found in wheat, barley, and ryeand derived products, leads to damage in the small intestine. It is estimated to affect 1 in 100 people worldwide. Celiac Disease can cause symptoms including abdominal pain, diarrhea, nausea, and vomiting. Long-term complications of Celiac Disease may include malnutrition, accelerated osteoporosis, nervous system problems and problems related to reproduction. Currently the only available treatment for patients with Celiac Disease is maintaining a gluten-free diet, which involves strict, lifelong avoidance of exposure to gluten. IL-15 has been singled out as a major driver of Celiac Disease for a long time, yet there are no IL-15-targeting drug available to address this important medical need.

About Eosinophilic Esophagitis and IL-15Eosinophilic esophagitis (EoE) is a chronic, life-long immune-mediated disease of the esophagus (the tube connecting the mouth to the stomach) triggered by food antigens in at-risk individuals. This damage makes eating difficult or uncomfortable, potentially resulting in poor growth, chronic pain, and/or difficulty swallowing. It may evolve into a fibrotic process that causes a narrowing of the esophagus and can provoke food impaction, requiring a surgical procedure to remove the food and/or dilate the esophagus. Although still an orphan condition in Europe and the USA (CALY-002 has received Orphan Drug Designation for the treatment of EoE), doctors are seeing more and more children and adults suffering from EoE. The only medical treatment approved for EoE to date, in Europe, is a local formulation of immune -suppressive corticoids. While long attributed to the presence of eosinophils alone, it is now clear that EoE is driven by other factors, many demonstrated by Calypso Biotech to be controlled by IL-15.

About Calypso Biotech BVCalypso Biotech BV is a private biotechnology company leveraging its unique knowledge of IL-15 biology into the development of medical breakthroughs. Calypso Biotech was established as a spin-off by the healthcare business of Merck, founded by Alain Vicari, Yolande Chvatchko and M Ventures, and is headquartered in Amsterdam, The Netherlands. Calypso Biotech is also a Resident Company of Johnson & Johnson Innovation JLABS in Beerse, Belgium (JLABS @ BE).

Contact

Calypso Biotech BVThis email address is being protected from spambots. You need JavaScript enabled to view it.

Keywords: Humans; Glutens; Diet, Gluten-Free; Celiac Disease; Hordeum; Triticum; IL15 protein, human; Interleukin-15; Eosinophilic Esophagitis; Healthy Volunteers; Immunologic Memory; T-Lymphocytes; Diarrhea; Netherlands

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Calypso Biotech Announces Successful Dosing of First Phase 1 Cohort with Anti-Interleukin-15 (IL-15) Monoclonal Antibody CALY-002 for the Treatment of...

She is what she eats: Keeping cows fit and healthy longer with the right feeding strategy – Farmers Review Africa

Home Feature She is what she eats: Keeping cows fit and healthy longer with the right feeding strategy

What goes for human beings, also goes for dairy cows: A healthy and individually tailored diet is one of the most important requirements for high performance and well-being. With GEAs automated feeding systems, the perfect recipe can be conveniently delivered to each animal group. Years of experience as well as the latest scientific findings advise systems for precision feeding. The success speaks for itself: Farmers are achieving significantly improved animal health with above-average herd performance. In addition, better feed quality and resource-friendly feed conversion go hand in hand with huge time and labor savings, as well as the ability to optimize feeding strategies in a targeted and result-oriented manner.

Measuring out fodder is surprisingly easy in the feed kitchen. Depending on the size of an operation and the number of animals needing to be fed, space-saving bunkers for basic feed types as well as containers for minerals are installed. The recipes selected feed types and desired quantities can be conveniently entered into the WIC System. Weighing and mixing take place automatically in the stationary mixer or directly in the feed wagon. And while the feed wagon provides the selected animal groups with individual, freshly prepared rations at predetermined times, current milking results can be checked against the feeding strategy. Precisely these valuable conclusions help dairy farmers achieve short- and long-term goals. Because results can be replicated, producers are able to continually optimize the feeding strategy.

Its clear that individual feed mixes designed to suit a cows nutritional needs will best support its performance. In conventional feeding systems, however, dividing animals into performance groups, means a corresponding increase in work hours. With GEAs automated feeding systems, it doesnt matter how many groups are desired, the only work required is filling the bunkers, which only takes about 30 minutes. Every animal group is provided with the optimal feed ration: cows at the beginning or the end of lactation, dry cows as well as youngstock and heifers receive exactly the rations they need for their current lactation phase, their calculated calving period, or their recommended weight gain.

Heifers are the cows of the future. The way they are fed improves not only their well-being, but has a direct influence on their lifelong productivity. To support growth in the best possible way, GEA has developed automated feeding systems, where even small batches can easily be mixed and distributed according to plan. The latest research shows that heifers that were fed according to a precise feeding plan grew faster. In addition, they calved significantly earlier than in the conventionally fed control group (22.2 compared to 24.6 months). Meanwhile, the costs for rations as well as feed and supplements were nearly identical in both groups. Thanks to the earlier age at first calving and the increased willingness to perform over the animals entire life cycle, an investment in the automated feeding system pays off. The additional time required for preparing and distributing smaller rations is taken on by the system.

Feeding that is efficient for the farmer also helps cows absorb nutrients better for their own energy balance. In a cows stomach, there are millions of active bacteria that support the digestion of plant fibers. Because microorganisms cannot adapt very well, they need a relatively stable environment to carry out their tasks. The ideal pH level for a good feed conversion is at 5.5 6. An efficient method to keep the pH level in the rumen as consistent as possible is to provide feed throughout the day. Another argument for frequent feeding is supplied by the cow herself: her tendency to sort against small particles in her feed contributes to an unbalanced diet, which in turn has a negative impact on the pH level in the rumen. Here, too, frequent feeding is a successful countermeasure, as it verifiably reduces variations in the pH value during the day.

The last in line only get the leftovers: this often applies when feed is conventionally distributed on the feeding table. Since the nutritional value of the ingredients begins to deteriorate as soon as feed is distributed, low ranking cows, who are initially denied access to the feeding table, can maintain neither their feed and nutrient intake nor milk production to the full extent. The common practice of pushing the feed forward may provide all cows with access to it, but cannot guarantee the uniform quality of the feed mix. When animals are fed more often, they distribute their feed intake more evenly throughout the day. At the same time, the movement profile of lower ranking cows reveals that when they get equal access to the feeding table, they are better fed with all the necessary nutrients. The otherwise labor-intensive processes of weighing, mixing and distributing can conveniently be carried out by the automated feeding system. All programmed tasks are taken care of on time, precisely according to plan.

Back to feed quality and the advantages of a feed kitchen: At conventionally feeding dairy farms, mixed feed rations are often exposed to the air for long periods, which accelerates the deterioration and decay of nutrients particularly during the summer months. In automated feeding systems, this process is slowed down by the storage in feed bunkers, because feed is only prepared and mixed during each day as needed. Aside from the order of feed components, a feed mixture can be optimized by the type of cut applied as well as single or multiple mixing. Best results are achieved when starting with dry and ending with wet ingredients. Thats why farmers using GEAs systems recommend beginning with dry fodder and grains, then adding concentrates, minerals and vitamins and finishing with silage, molasses and water. This is how the feed kitchen offers the best conditions, because its the quality of the mix that determines whether cows take in the right amount of nutrients for milk production, reproduction and good health.

A pioneering function in automated feeding consists of updated performance indicators supplied by process control and the software. To this end, daily procedures such as feed quantities distributed per group, mixing times or feed intake are recorded and referenced. The immediate evaluation and analysis in connection with information on milk performance of individual animal groups or heifers weight gain make it particularly easy for the farmers to make changes to feeding plans in real time and to improve feeding efficiency step by step. It makes no difference whether the farm feeds a full, partial or mixed ration in combination with grazing.

Latest research findings served fresh to the feeding table The proof is in the research: for cows well-being, health and vitality, freshly prepared feed should be distributed multiple times a day and as individually as possible. Feeding strategy, feeding frequency and feed mix are directly connected to animal stamina, milk yield and milk quality. The fact that efficient feeding and a successful feed strategy is not only good for cows, but is generally the decisive factor for the profitability of dairy farms, can not only be seen in improved herd performance, but is directly connected to sustainable feed implementation, savings in feed costs as well as improved reproduction. With significant labor savings, GEAs automated feeding systems offer every opportunity to test, analyze and reproduce promising feeding strategies at any time..

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She is what she eats: Keeping cows fit and healthy longer with the right feeding strategy - Farmers Review Africa

Late-Breaking Study Results of the Supreme HT Healing-Targeted DES Demonstrated Equivalent Outcomes with Exceptional Safety – BioSpace

TIANJIN, China, Nov. 17, 2020 /PRNewswire/ -- SINOMED today announced that Prof. Alexandra Lansky from the Yale School of Medicine, USA, presented data from its first inter-continental PIONEER III study comparing the safety and efficacy of the Supreme HT (Healing-Targeted) Drug-Eluting Stent, to the Xience or Promus Durable Polymer Drug-Eluting Stent (DP DES). One-year results, revealed at the 2020 American Heart Association Scientific Late-Breaking Trials Session, showed equivalent clinical performance of the Supreme HT to the market-leading DES and will be used to support U.S. Food and Drug Administration and Japanese regulatory approvals.

The PIONEER III study enrolled 1,629 patients (randomized 2:1 experimental to control) from North America, Europe and Japan and had a primary composite endpoint of target lesion failure (TLF) at one-year. The TLF outcomes showed that the Supreme HT met the non-inferiority endpoint at 5.4% compared to 5.1% from the DP DES (p=0.002). A grouped analysis of secondary endpoints showed a numerically better result for Supreme HT in cardiac death or target-vessel myocardial infarction (TV MI) with 3.5% in the Supreme HT arm compared to 4.6% in the control arm (p=0.27). Lower late stent thrombosis data (Supreme HT 0.1% compared to DP DES 0.4%, p=0.22) also suggested exceptional safety for the HT DES. A powered, landmark TLF analysis evaluating the healing superiority of Supreme HT between 1 and 5 years is ongoing.

"I am very pleased that Japanese patients will benefit from the most advanced DES in the US, Europe and Japan," said Shigeru Saito, MD, Shonan Kamakura General, Japan and primary investigator of the Japanese cohort of the PIONEER III study . "The results combined with the safety measurement of cardiac death, target vessel MI and late stent thrombosis favor the Supreme HT, supporting the early endothelial healing concept."

Contemporary DES have emphasized delay healing through prolonged drug delivery to suppress the body's response to injury, hypersensitivity, or progression of disease. The Supreme HT development was based on the "wound-healing window" concept originally proposed in 2013 and represents a novel class of DES that highlight the importance of early, timely healing. Through patented designs and proprietary processes, the Supreme HT was tailored to help patients accelerate their wound-healing process and restore their natural endothelial function. This healing-targeted mechanism may help overcome the long-standing problem of tradition-DES implantation, allowing for safer long-term results.

"We are very grateful to the extraordinary group of medical professionals and all the patients who have endured through this difficult pandemic and completed this study milestone in such a timely and professional manor," said Jianhua Sun, PhD., Chairman & Chief Executive Officer of SINOMED. "The results have been extremely encouraging and if we reach superiority in the landmark analysis, we could revolutionize the understanding of healing and the future of implantable devices,"

More information on the PIONEER III study is available at http://www.clinicaltrials.gov, identifier: NCT03168776.

About SINOMED

Sino Medical Science Technology Inc. (SINOMED), a global medical device company engaged in research, development, production, and commercial distribution of interventional devices. We are focused on developing breakthrough technologies to target unmet clinical needs in the interventional treatment of coronary, neurovascular and structural heart disease. Our mission is to expose more patients to the benefits of our medical innovations, increasing patient longevity and quality of life.

For more information, visit: http://www.sinomed.com

SINOMED B.VCindy ZhengT: +31 10 307 6295E: cindy.zheng@sinomed.com

Photo - https://mma.prnewswire.com/media/1333951/SINOMED_Stent.jpgLogo - https://mma.prnewswire.com/media/1333950/SINOMED_Logo.jpg

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Late-Breaking Study Results of the Supreme HT Healing-Targeted DES Demonstrated Equivalent Outcomes with Exceptional Safety - BioSpace

Next Avenues 2020 Influencers In Aging Fight Covid-19, Loneliness And Ageism – Forbes

By Next Avenue Editors

Next Avenue

For the past six years, Next Avenue public medias first and only national journalism service for Americas older population has released a list of Influencers in Aging.

Weve named 20 trailblazers who are each uniquely changing how we age and think about aging. This years list includes a new and distinctive group of five honorees specifically chosen for their contributions to advance the safety and wellness of older Americans during the Covid-19 pandemic.

The coronavirus pandemic changed pretty much everything in 2020 and that goes for how we chose this year's Next Avenue Influencers in Aging and why.

As we all know, the pandemic has been cataclysmic to people's lives and exposed major gaps in government and health care policies, institutions and services. Disturbingly, the pandemic has also amplified ageism and negative stereotypes of aging. These and other effects of COVID-19 will continue for months, if not years.

Next Avenues 2020 Influencers in Aging are:

Jean Accius senior vice president of AARP Global Thought Leadership. He led the AARP team to produce The Longevity Economy report documenting the enormous dollar value of Americans 50+.

Angela Burton founder of Feet to the Fire Writers' Workshops a creative program that inspires adults to challenge themselves through expressive writing. Her work inspires creative action that enhances the lives of thousands of older adults.

Christina Da Costa senior director of communications at SAGE, a national advocacy and services organization thats been looking out for LGBT elders since 1978. She led groundbreaking work that used technology to connect vulnerable adults to community leaders and allies during the pandemic.

Robert Espinoza vice president of policy at PHI, where he oversees its national policy advocacy, research and public education division. PHI promotes and advocates for quality direct care jobs. Espinozas work has revealed and worked to correct inequities in the direct care workforce, predominantly made up of women, people of color and immigrants.

Michael J. Fox Canadian-born actor, author and advocate who has navigated a five-decade career in entertainment and lived with Parkinsons disease since 1991. He has become the face of millions who live with chronic degenerative diseases and a champion for funding research that advances treatment options.

Dr. Sharon Inouye director of the Aging Brain Center at Hebrew SeniorLife and professor of medicine at Harvard Medical School. She has become one of the nations leading experts during the pandemic on the need to include older adults in COVID-19 vaccine trials. Dr. Inouye is also an internationally recognized leader in aging and geriatric medicine. Her work focuses on delirium in hospitalized older patients, with more than 300 peer-reviewed original articles to date.

Charlotte Japp The millennial founder of CIRKEL, an intergenerational platform that aims to connect younger and older workers in shared learning and networking opportunities. Her work is helping older professionals stay in the workforce longer and impart valuable mentorship to younger workers and vice versa.

Raymond Jetson An Encore Public Voices Fellow who leads MetroMorphosis in Baton Rouge, La. and is urging older Black men to mentor younger Black adults and youth. His organization mobilizes engaged citizens in inner-city neighborhoods to design and implement sustainable solutions to persistent community challenges.

Heidi Johnson director of behavioral economics at Financial Health Network. She wrote a breakthrough report on personal finance technology use and needs of lower-income older Americans. At FNN, Johnson leads work to leverage behavioral insights in the design and development of products that support consumers financial health, including retirement planning.

Stephen Johnston Co-founder of Aging2.0, a global innovation platform for aging that connects entrepreneurs, care providers and older adults to identify and build solutions to help people age better.

Dr. Dominic H. Mack Professor of family medicine at Morehouse School of Medicine and co-director of The National COVID-19 Resiliency Network, which assembles local, state and national partners to reduce the impact of COVID-19 on vulnerable populations.

Grandpa Chan and Grandma Marina Husband and wife from South Korea, Chan Jae Lee and Kyong Ja Ahn became internationally recognized for their virtual storytelling, which began as a way to connect with their four grandchildren. The couple just published a book (Looking Back, Life was Beautiful), regularly delight their 400,000 Instagram followers with original stories, videos and illustrations and have been featured by The New York Times NYT and BBC.

Dr. Vivek Murthy Former Surgeon General of the United States who has focused on chronic stress and isolation as prevalent problems that have profound implications for health, productivity and happiness.His 2020 book Together: The Healing Power of Human Connection in a Sometimes Lonely World underscores the detrimental effects of loneliness and calls for resources and innovation to combat it. He is also co-chair of President-Elect Biden's COVID-19 Transition Task Force.

Dr. Jeremy Nobel Founder and president of the Foundation of Art & Healing, and architect of the UnLonely Project that was created in response to the growing public health concern of social isolation and loneliness. The initiative broadens public awareness of the negative physical and mental health consequences of loneliness associated with a wide range of living conditions and promotes creative arts-based approaches to reduce the burden.

Michael Osterholm Director of the Center for Infectious Disease Research and Policy at the University of Minnesota, where he has provided public health guidance to government agencies and media outlets during the COVID-19 pandemic. He is a former Minnesota state epidemiologist and author of the New York Times best-selling 2017 book, Deadliest Enemy: Our War Against Killer Germs. He is also a member of President Biden's COVID-19 Transition Task Force.

Sian-Pierre Regis Award-winning journalist and cultural critic who directed the feature-length documentary Duty Free about his immigrant mother, who was abruptly fired from her job as a hotel housekeeper at the age of 75, and the economic insecurity facing her and millions in her generation.

Jason Resendez Executive director of the Latinos Against Alzheimers Network. He is a leader in the nations efforts to address brain health disparities impacting Latinos. Resendez spearheads coalition building, strategic convening and patient advocacy in the Latino community.

Andrew Saul Commissioner of the Social Security Administration, who has made customer service a top priority for Social Security beneficiaries, including adding more than 1,000 staffers to answer questions on the agencys toll-free line and improving its website so Americans can better see and understand the Social Security benefits theyll receive.

Jennifer Sheets President and CEO of Interim Healthcare. She worked with the White House in 2020 to advocate that home care clinicians receive essential workers status.

C. Grace Whiting President and CEO of The National Alliance for Caregiving. Whiting has been a leader in research around caregiving in America, producing the nations first national policy study of 1,400+ rare disease caregivers with Global Genes and helped author AARPs Caregiving in the U.S. 2020 report.

When you read our interviews with this year's winners and see the video and audio clips from them in our articles, we think you'll see why the 2020 Influencers in Aging are a remarkable, spirited group with groundbreaking achievements.

Be sure to read, at the end of each interview, the Influencer in Aging's answers to two questions we asked them all:

If you could change one thing about aging in America, what would it be

How has the COVID-19 pandemic changed your perspective on aging?

Their responses will tell you a lot about why these insightful honorees made the cut for 2020. We could not be more excited to uplift the work of these extraordinary people who are tackling these questions and finding new ways for living longer, healthier and happier lives.

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Next Avenues 2020 Influencers In Aging Fight Covid-19, Loneliness And Ageism - Forbes

Intrathecal Gene Therapy Use Might Be Safer With ‘Silencing’ Step – SMA News Today

By taking advantage of a natural process of gene silencing, a new gene therapy approach appears to prevent the toxicity todorsal root ganglion(DRG) a specific cluster of sensory neurons seen in non-human primates during gene therapy studies for neurological disorders, researchers report.

The approach successfully protected the primates DRG from excessive activity of the introduced gene known as a transgene and subsequent toxicity, without affecting the transgenes activity elsewhere in the nervous system.

DRG inflammation and toxicity was observed in non-human primates after spinal canal injection of AVXS-101 approved asZolgensma when given as an intravenous infusion prompting a partial hold of a Phase 1/2 trial (NCT03381729) to allow for further investigation.

That trial, calledSTRONG, is testing intrathecal (spinal canal) injection of this gene therapy in children with spinal muscular atrophy (SMA) between 6 months and 5 years old.

The study, MicroRNA-mediated inhibition of transgene expression reduces dorsal root ganglion toxicity by AAV vectors in primates, was published in the journal Science Translational Medicine.

We believe that this new approach could improve safety in genetherapyuniversally, as well as in SMA, Juliette Hordeaux, PhD, the studys first author at University of Pennsylvanias Perelman School of Medicine (Penn Medicine) said in a press release.

This approach could be used to design other gene therapy [carriers] to repress transgene [activity] in the cell types that are affected by the toxicity and not others, which is critical, because you need [such activity] everywhere else to effectively treat the disorder, added Hordeaux, who is also senior director of translational research for Penn Medicines gene therapy program.

Gene therapy works to deliver a functional version of a gene to correct or replace a faulty gene within specific cells in the body. Most therapy approaches today use a modified and harmlessadeno-associated virus(AAV) as a carrier for the working gene, a vehicle to transport it to a target cell.

But previous studies, including primate work by Penn researchers, showed that AAV-based gene therapies targeting the central nervous system (CNS; brain and spinal cord) can damage the DRG, a cluster of neurons of the spinal nerve that bring sensory information from the periphery to the spinal cord.

Notably, DRG toxicity was observed in studies regardless of the therapys route of administration (directly into the bloodstream or into the spinal canal). No reports of such toxicity in humans, including children treated in STRONG, are known.

Conventional immunosuppressive regimens were ineffective in preventing this toxicity, strongly indicating that an excessive immune response was not its cause. This led Hordeaux and her Penn colleagues to evaluate whether the damage was related to excessive levels of the transgenes product, which could cause cellular stress.

To test their idea, they took advantage of RNAi, a natural process of gene silencing, in which microRNA (miR) molecules bind to a specific messenger RNA (mRNA), targeting it for destruction and preventing the production of that protein. (mRNA is the molecule derived from DNA and used as a template for protein production.)

Since the miR183 complex is specifically produced in sensory tissues and organs such as dorsal root ganglion, the researchers introduced miR183s sequence targets at the endof the transgene sequence in an AVV. With this, any mRNA produced from the transgene would be destroyed in DRG neurons by the naturally present miR183, preventing protein production in these cells.

Researchers then compared the effects of administering AAV with a transgene containing or not containing miR183s sequence targets into the cerebrospinal fluid (the fluid that bathes the brain and spinal cord) of non-human primates.

Introducing miR183s sequence targets in the transgene were found to significantly reduce its mRNA levels and subsequent toxicity in DRG neurons, without affecting the transgenesmRNA levels elsewhere in the primates brain.

Steroids given to primates treated with unmodified AAVs, in contrast, failed to alleviate DRG damage, despite their known anti-inflammatory and immunosuppressive effects. This ineffectiveness was consistent with the proposal that immune system activity does not mediate this neuronal toxicity, the researchers wrote.

We were concerned about the DRG [toxicity] that was observed in most of our [non-human primate] studies, said James M. Wilson, MD, PhD, the studys senior author, and gene therapy program director and a professor of medicine and pediatrics at Penn Medicine.

This modified [viral] vectorshows great promise to reduce DRGtoxicityand should facilitate the development of safer AAV-based gene therapies for many CNS diseases, Wilson added.

Novartis gene therapy Zolgensma, when given directly into the bloodstream, is currently available for use in newborns and toddlers up to age 2 with any type of SMA in the U.S. and Japan, and to those with almost all types who weigh up to 21 kilograms (about 46 pounds) inEurope.

To meet aU.S. Food and Drug Administration(FDA) request for a pivotal confirmatory study of the gene therapys use with older SMA patients, who would be treated via intrathecal (IT) injection, Novartisplans to launch a new AVXS-101 IT trial.

This administration route is favored for those beyond toddler age, as it is thought to better target themotor neuronsdamaged by the disease.

According to the company, this IT trial cannot include U.S. sites until the hold on STRONG is lifted.

Marta Figueiredo holds a BSc in Biology and a MSc in Evolutionary and Developmental Biology from the University of Lisbon, Portugal. She is currently finishing her PhD in Biomedical Sciences at the University of Lisbon, where she focused her research on the role of several signalling pathways in thymus and parathyroid glands embryonic development.

Total Posts: 85

Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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Intrathecal Gene Therapy Use Might Be Safer With 'Silencing' Step - SMA News Today

ElevateBio and AgBiome Announce LifeEDIT Will Join ElevateBio’s Portfolio of Innovative Cell and Gene Therapy Companies – BioSpace

Nov. 16, 2020 12:30 UTC

- Highly innovative genome editing technology platform accelerates and broadens ElevateBios cell and gene therapy enabling technologies

- LifeEDIT Therapeutics to develop its own pipeline of potentially life-transforming therapeutics

- LifeEDIT Therapeutics to leverage its novel gene editing platform with strategic partners including ElevateBio portfolio companies

CAMBRIDGE, Mass. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- ElevateBio, a Cambridge-based cell and gene therapy holding company, and AgBiome, a leader in developing innovative products from the Earth's microbial communities, today announced that LifeEDIT Therapeutics has joined ElevateBios growing portfolio of therapeutic, technology and manufacturing companies. LifeEDIT Therapeutics combines a highly innovative genome editing platform, derived from AgBiomes massive proprietary microbial library, with ElevateBios proven expertise in the discovery and development of new cell and gene therapies. LifeEDIT will continue to develop internal cell and gene therapies while further strengthening its platform of diverse genome-editing enzymes and provide gene editing expertise to strategic partners including ElevateBio portfolio companies. AgBiome retains rights for gene editing in agriculture, animal health, and diagnostics.

Genome editing technologies have revolutionized the way we develop cell and gene therapies and regenerative medicines, said Mitchell Finer, Ph.D., President, ElevateBio BaseCamp, and newly appointed Chief Executive Officer, LifeEDIT Therapeutics. However, in order to realize the promise of, and democratize, these highly innovative therapeutic approaches, the field needs to access novel RNA-guided nucleases and base editors that offer greater specificity and broader genome coverage, which LifeEDIT can provide. LifeEDITs genome editing platform is one of the most versatile in the field and was the natural fit as we continue to build a world leading cell and gene therapy offering.

Members of ElevateBio will join the newly formed LifeEDIT Therapeutics management team, which will continue to benefit from its existing visionary scientific leadership and research team. The combined executive team will include:

Over the last 18 months we have built a truly unique platform of numerous RNA-guided nucleases with diverse PAM requirements, for which weve been able to show functional activity, said Tedd Elich, Ph.D., Chief Scientific Officer, LifeEDIT Therapeutics. The wide range of gene editing enzymes across our platform increases our ability to target any genomic sequence of interest and will allow us to tackle some of the most challenging diseases, bringing desperately needed, potentially curative, therapies to patients in need.

"AgBiome's GENESISTM platform is built on our microbial collection, their complete genome sequences, and our industry-best data science platform to identify new useful functions, said Eric Ward Co-Chief Executive Officer, AgBiome. This unique resource formed the basis for the many genome editing technologies that are now part of LifeEDIT Therapeutics. We look forward to continuing to collaborate with the LifeEDIT team as they build a world-class pipeline of clinical candidates and bring a broad array of genome editing technologies to innovators across the biotechnology industry."

About Genome Editing and LifeEDIT Therapeutics Platform

Genome editing technologies have revolutionized the way cell and gene therapies and regenerative medicines are discovered and developed by allowing genetic material to be removed, added, or altered at specific locations in the genome. While these technologies are in widespread use experimentally, enzymes that offer broader coverage and greater specificity are needed for creating novel cell and gene therapies.

To meet the need for better genome editing approaches, LifeEDIT Therapeutics has built one of the worlds largest and most diverse arrays of novel RNA-guided nucleases (RGNs) and base editors that are active in mammalian cells. These RGNs were developed using AgBiomes proprietary collection of more than 90,000 microbes and their complete genomes. LifeEDIT Therapeutics is investigating these proprietary RGNs, which are sourced exclusively from non-pathogenic organisms, to develop new gene editing tools with higher fidelity, novel functionality, reduced immune response risk, and easier delivery. LifeEDIT Therapeutics nuclease collection also has a broad range of Protospacer Adjacent Motifs (PAMs) short sequences that must follow the targeted DNA sequence in order for the enzyme to make cuts that offer unprecedented access to genomic loci of interest. The LifeEDIT Therapeutics RGNs offer flexible editing options which encompass knock-out and knock-in capabilities, transcriptional regulation, and base editing when coupled with its proprietary deaminases.

LifeEDIT Therapeutics next generation editing systems will propel the development of novel human therapeutics by enabling ex vivo engineering for cell therapies and regenerative medicines and in vivo delivery of gene therapies. In addition to developing its own pipeline of cell and gene therapies, LifeEDIT Therapeutics will continue to build its platform of novel nucleases, provide gene editing expertise to strategic partners and ElevateBios portfolio companies, and form other third-party partnerships to discover and develop new therapies.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating and life-threatening diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and translational research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners, are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.

ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, The Invus Group, Emerson Collective, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures.

ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.

About AgBiome

AgBiome partners with the microbial world to improve our planet. AgBiome discovers and develops innovative biological and trait products for crop protection. The proprietary GENESIS discovery platform efficiently captures diverse, unique microbes for agriculturally relevant applications, and screens them with industry-best assays for insect, disease, and nematode control. Through its commercial subsidiary, AgBiome develops and sells proprietary crop protection solutions. The first of these, Howler, is a revolutionary fungicide for disease control in a broad variety of crops. AgBiome and Genective recently formed a strategic partnership to establish a new leader in insect traits, a market with over $5 billion in annual opportunities. AgBiome has a global R&D collaboration with Elanco Animal Health Incorporated (NYSE: ELAN), to develop nutritional health products for swine. AgBiomes investors include Polaris Partners, ARCH Venture Partners, Fidelity Investments Inc., UTIMCO, Pontifax AgTech, Innotech Advisors, Syngenta Ventures, Leaps by Bayer, and Novozymes. For more information, visit http://agbiome.com.

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ElevateBio and AgBiome Announce LifeEDIT Will Join ElevateBio's Portfolio of Innovative Cell and Gene Therapy Companies - BioSpace

Orgenesis CEO talks disruption: ‘We are the Uber of the cell and gene therapy space’ – BioPharma-Reporter.com

Maryland, US headquartered company, Orgenesis, is championing a model that aims to bring down those costs it works with partner hospitals throughout the commercialization process.

The companys CGT platform, consisting of a pipeline of licensed cell and gene therapies, scientific expertise, customised processing systems, and an ecosystem of healthcare providers and research institutes, is designed to provide a pathway for groundbreaking autologous therapies to become commercially available on an industrial scale and at prices accessible to large populations.

Orgenesis business model is one focused on decentralization, enabling precision medicines to be prepared on-site at hospitals. In this way, we can really expedite cell and gene therapy development, said Orgenesis CEO, Vered Caplan.

With operations in the US, Europe, Israel and South Korea, Orgenesis has now created an international network of point of care (POCare) centers to serve patients directly in the hospital setting.

Beyond the US, we have POCare centers in many countries in Europe such as Greece, the Netherlands, Belgium, Slovenia, Italy and Spain; we also have centers in Israel, in Korea and in India and we will be starting up soon in Dubai,said the CEO.

The goal is to make gene and cell therapies feasible for large numbers of patients, said Caplan. We used to work as a contract development and manufacturing organization (CDMO) but we sold that business to Catalent at the beginning of the year.

The centralized processing and supply chain model only served to create a frustrating working environment, with plenty of constraints, said the Orgenesis lead.

We realized very quickly that we couldnt really ramp up to large scale relying on that kind of centralized model, particularly for autologous products, which represent most of the market today. It takes six months to train someone to work in a high-grade cleanroom there is a lot of work and expense involved in that and there is a limited number of patients that can be treated in such cleanrooms the utilization rate is very low - it [centralized processing and supply] is a very inefficient and costly way to supply and to develop medicine there is so much manual work involved, she told BioPharma-Reporter.

The company had been working for a number of years, investing a huge amount of effort in developing a range of automation solutions to supplant those manual processes, as well as building its mobile CGT processing labs and units (OMPULs), she said.

We had been fielding so many requests from hospitals that wanted to collaborate with us, asking us to make or scale up their CAR-T and other therapies. We realized that in order to get this done, we needed to take a decentralized approach and that we needed to provide a solution, not only for one hospital, but for every hospital that wanted these type of therapies; and we saw that such a model brings down the price of the therapy tremendously.

A hospital gives Orgenesis a license to work on the therapy, on the processing; production of the final product is automated and supplied via an on-site point-of-care processing unit. Orgenesis then sets about democratizing the treatment,making it available to any hospital in its POCare network.

The company says the final customized, automated processing system it has developed, with the integrated specific therapy, solves a variety of processing and cost hurdles. It results in a lower required grade of cleanroom, it simplifies facility management requirements, it enables multi-batch processing per cleanroom, which means reduced technical staffing. Moreover, the localized processing eliminates the many logistical difficulties associated with traditional, centralized manufacturing and transport.

Overall, it is said to provide faster turnaround, increased safety, and improved quality control management on-site.

Hospitals really want to supply CGTs, while patients are reading about such treatments and making inquiries of healthcare providers, she added.

Ours is really a combined licensing and service model.

We are like Uber. If you have a car, you want to make some extra revenue, you call up Uber and it gives you the network, the technology and all the operating procedures to be a taxi driver. That is very much what we do in terms of hospitals we give them the ability to be biotech companies, because this is not the standard thing they do, they dont want to take responsibility for cell and gene therapy it is too much for them. They want to treat patients, but they want to have that local supply, so we give them the technology and the capabilities to do that. We give them regulatory support for clinical trials, we give them CRO support, we give them a network - so they can function and do what they need to do, which is to undertake research and treat patients.

Orgenesis intends to leverage its network of regional partners to advance the development and commercialization of its therapeutic pipeline. Towards this end, it said its partners have committed to funding the clinical programs. In turn, the company typically grants its partners geographic rights in exchange for future royalties, and a partnership with Orgenesis to support the supply of the targeted therapies. Through this model, Orgenesis has already signed contracts, which it expect to generate over US$40M in revenue over the next three years, if fully realized.

On the therapeutic front, Orgenesis is focused on several key verticals, including immuno-oncology, anti-viral, and metabolic/auto-immune diseases.

It recently acquired Koligo Therapeutics, with the aim of leveraging Koligos 3D-V bioprinting technology across its POCare Platform. That technology, which utilizes 3D bioprinting and vascularization with autologous cells to create biodegradable and shelf-stable three-dimensional cell and tissue implants, is being developed for diabetes and pancreatitis, with longer term applications for neural, liver, and other cell/tissue transplants.

In February this year, Orgenesis announced that it has entered into a collaboration agreement with the John Hopkins University to utilize the POCare platform to develop and supply a variety of CGTs including cell-based immunotherapy technologies.

And the University of California, Davis (UC Davis) joined its POCare network in January. The collaboration will involve the scale up and integration of UC Davis lentiviral vector process.

Today we are very much in validation mode. Most of the therapies in this space, and the ones we have licensed from the hospitals I think we have about 25 today are all at different stages of clinical development. Some have been used to treat patients but that has all been done under hospital exception.

When we adopt a therapy into the network, we run it through the entire R&D, formal clinical and regulatory processes as [our goal] is a harmonized process, to have the same standard [in our closed systems] at our [POCare] centers, whether that is in Germany or Korea, said the CEO.

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Orgenesis CEO talks disruption: 'We are the Uber of the cell and gene therapy space' - BioPharma-Reporter.com

Now is the time for a paradigm shift in how we treat mental ill health Monash Lens – Monash Lens

This week, Prime Minister Scott Morrison announced the findings of the Productivity Commission report into mental health. It estimated that the economic cost of mental ill-health and suicide in Australia was up to $70 billion a year, and that disability and early death caused byit cost a further $151 billion a year.

If there has ever been time for a paradigm shift in the way we conceptualise mental health and mental illness, it must be now. As we battle with a global rising tide of mental illness, there should be recognition that radically new approaches are needed to treat these diseases.

Part of the reason that the incidence of mental illness is increasing in the community is because we're now more aware of it, and also because there's far less stigma attached to it than in the past.

Butdespite more people seeking help, there are also more people, globally, committing suicide, with an alarming increase over the past three years after some stability in these figures since the 1970s. And that was before COVID-19 brought its isolation, unemployment, anxiety and illness to our world.

In the same way we now routinely offer personalised precision medicine for cancer treatment with the genetic makeup of an individuals tumour determining treatment rather than broad-brush diagnoses such as lung cancer or breast cancer it'stime to look at psychiatric illness in the same way.

Disorders such as schizophrenia and depression are not single diseases, but labels used to cluster symptoms.

In the case of depression, these symptoms include constant sadness, irritability, hopelessness, decreased energy, and sleeping problems. Schizophrenia has numerous disabling symptoms, including delusions, hallucinations, memory and thinking problems, and depression.

Both these conditions have a strong link with family heredity. Depression has a genetic link of approximately 40-70% ,and schizophrenia a genetic link of between 50-80%. The problem is that these disorders, like others such as bipolar disorder and autism, have multiple genes that are in play, which makes fanciful the approach of targeting a single gene with a drug or therapy and hoping to treat everybody.

But what if we had a similar program to that for cancers, which also have multiple genetic causes, dedicated to mental health issues?

Fifty years ago, only one in three people diagnosed with the blood cancer leukaemia would survive a year with the disease. Now, that statistic has been flipped, with at least half surviving up to 10.

The changes are even more remarkable for other cancers, but it was a long slog determining the genes associated with each disease, and developing treatments that targeted each genetic mutation. Then there was the enormous task of being able to determine that genetic mutation, and tailoring treatment for every person diagnosed with cancer.

It was predicted, decades ago, that such an approach might work, but it would be enormously costly. And yet here we are with personalised medicine one of the backbones of oncology.

Of course, psychiatric illness is harder to tackle than cancer. We cant just sample bits of peoples brains to look for genetic mutations. Instead we have to rely on family histories, brain imaging and electrical recordings, blood assays, and the use of animal models to link a disease to a gene(s), and then find a drug that targets that gene.

Melbourne is one of the few places in the world that has these sorts of programs. In 2018, a global study led by University of Melbournes Professor Sam Berkovic examined the DNA of more than 45,000 people with epilepsy, leading to the discovery of 11 genes associated with the disorder, paving the way for drugs that could benefit millions of patients who didn't respond to existing treatments.

At Monash, we have similar programs looking at the genes and proteins that cause schizophrenia and other psychotic disorders, with a view to individualising treatments for people with different types of the disease.

We're amida mental illness epidemic, and quicker recognition and providing more treatment for those in need is extremely important. But we need a paradigm shift in the way we tackle mental illness, in the same way those leukaemia researchers did 40 years ago.

Professor Suresh Sundramis a speaker at the From the Front Line: Rethinking Mental Health webinar, at 11.30am on Wednesday, 25 November. You can register for the event here.

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Now is the time for a paradigm shift in how we treat mental ill health Monash Lens - Monash Lens

Biopharma Money on the Move PharmaLive – PharmaLive

A quick read of whose wallets got thicker in the biopharma industry,from largest to smallest.

D3 Bio

Industry-veteran George Chen left a seven-year career at AstraZeneca to launch his ownShanghai-based biotech, D3 Bio, with the support ofbig-nameinvestorslikeBoyu Capital, Matrix Partners China,SequoiaCapital China, Temasek and Wuxi AppTecs Corporate Venture Fund. At this point D3 is keeping its pipeline close to the chest.But Chensays its the approach thatsunique. The company will startwith insights from clinical development and a market assessment of unmet needs and use that to guide the clinical development path. D3 will use this$200 million Series Ato build out an R&D team focused on precision medicine in the realms of immunology and oncology.

Metagenomi

Unlocking the power of microbial evolution,Metagenomimines the worlds natural microbial environment to rapidly develop effective cures to treat incurable genetic diseases. A recent$65 million Series Awill help accelerate the expansion of its gene editing systems for therapies in oncology and genetic-related diseases.This means developing a vast database of gene editing capabilities to enable unprecedented therapeutic approaches. Working with visionary investors, such as Leaps by Bayer and Humboldt Fund, will allow us to deliver on our promise to partners and fuel the development of our own pipeline of innovative curative medicines, Thomas said in a statement.

AliveCor

AI companydisguisedas a medical device companyAliveCorpicked up$65 millionto ramp up speed on their remote cardiology platform. Amidst a pandemic, telehealth appointments have been increasingly necessary.AliveCorsECG will be strengthened withcardiologicaltelehealthservices as well as with detection and condition management services. To date, its products have served more than one million customers globally, recording over 85 million ECGs.AliveCorsKardiaMobiledevice is FDA-cleared and the most clinically validated personal ECG solution in the world.

Nereid Therapeutics

Birthed fromthe work of Clifford P.Brangwynne, Ph.D., Nereid hopes to translate the therapeutic promise of biomolecular condensates from physics to physicians.The biotech will take the$50 million Series Afunding andBrangwynnesproprietary technology enabling precise measurement, interrogationand control of phase separation in cells to develop their drug discovery platform. The platform holds potential to enable completely new approaches to discovering and developing therapeutics across a wide variety of diseases, focusing first on cancers and neurodegenerative disordersaffected by phase transitions.

KiraPharmaceuticals

Backed by$46 million in financingfrom biotech entrepreneur Peter Wirth and others,Kira launchedwith a mission of pioneering a new generation of complement-targeted therapies to treat immune-mediated diseases. With the financing in hand, Kira is aiming to have three assets in the clinic within the next 18 months. The companys most advanced program, P014, is a first-in-class biologic drug with a unique mechanism of action designed to inhibit both upstream and downstream complement targets.Former Sienna Biopharmaceuticals CEO Frederick Beddingfield will be at the helm.

Adagio Medical

Adagio is singing joyfully to the tune of a $42.5 million Series Eto supportthe commercialization of itsiCLASsystem.iCLASis Adagios intelligent Continuous Lesion Ablation Systempursuing both an Investigational Device Exemption trial and a European VT CE-Mark trial.Cardiac ablation is a large and growing market that faces significant challenges including disappointing clinical outcomes, long procedure times and unsatisfactory profitability for providers, saidTuan Huynh, ofArrowMark, one of the Series E investors joining Adagios board of directors. We believe Adagio represents a unique opportunity to transform ablation therapy and look forward to partnering with Adagios management team to support the companys growth and commitment to addressing challenges faced by physicians and their patients.

IniPharm

Founded in 2018 with a focus on liver disease,IniPharmbrought in$35 million with a Series Afinancing roundto take its lead program through to IND filing and into clinical trials.Theprogram targets the HSD17B13 gene, which according to CEO Brian Farmer, confers pretty amazing protection against liver disease.It doesnt appear to actually prevent the diseases causation, but slows progression to more serious illness by preventing inflammation, fibrosis and cirrhosis of the liver, which are the dangerous effects of liver disease.The potential for therapies that effectively target HSD17B13 activity is significant because it is linked to a broad spectrum of liver and related diseases, said Farmer.

InterVennBiosciences

InterVennlooks to ramp up their ability to discover biomarkersand design clinical trials with the help of a little AI. Funds from a$34 million Series Bwill expand its precision medicine platformfor cancer detection.InterVennstech platform targets carbohydrates known as glycans, looking for aberrant glycosylation of certain proteins, which are implicated in a variety of disease states, including inflammation.The companysVOCALprojectis evaluating a blood test to determine ifan ovarian tumor is benign or malignant.It is also conducting research into colorectal cancer and kidney cancer, hunting for clinically actionable biomarkers that can be used for diagnosis, prognosis, and detection of cancer recurrence, as well as predictive tests to help choose appropriate drugs.

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Biopharma Money on the Move PharmaLive - PharmaLive

Umoja banks $53M to develop triple-threat immunotherapies – FierceBiotech

As colleagues at Seattle Childrens Hospital, Andy Scharenberg, M.D., and Michael Jensen, M.D., knew they wanted to build a startup with a mission.

Although cell therapies like Novartis Kymriah and Gileads Yescarta have transformed treatment for certain blood cancers, Scharenberg, a pediatric immunologist by training, was struck by the numbers of patients who cant get those treatments.

I wanted to create something where the impact would be absolutely the biggest possible swing you could take, he said.

That was the driving force behind the pairs decision to found Seattle-based Umoja Biopharma, which debuted Tuesday with a $53 million series A round. Scharenberg envisions Umoja, which means unity in Swahili, as a unification of three approaches developed by scientists at Seattle Childrens and Purdue University.

Umojas multipronged approach relies on three platforms used in sequence.

We're going to give you a first medicine that's going to grow a cancer-fighting cell army in your body, and then we're going to send that cancer-fighting army in your body messages telling it how to kill off your tumor, Scharenberg said.

That first medicine is VivoVec, which generates cancer-fighting CAR-T-cells inside the body, boosting the immune system. This approach is different to that of current treatments Kymriah and Yescarta, which require T cells to be extracted from patients, engineered outside the bodyand then given back to the patient to fight cancer. VivoVec doesnt need pre-conditioninga treatment used to clear a path for cell therapies to work but that tends to suppress the immune systemand it mimics the bodys own immune response, reducing the risk of cytokine release syndrome, a common side effect of CAR-T treatments.

RELATED: Avrobio tracks improvements in first patient treated with Gaucher gene therapy

After two weeks to allow for the number of T-cells to expand in the body, the patient would then receiveTumorTag, which binds to both tumor cells and the shields they use to hide from the bodys natural immune defenses. As its name suggests, the technology tags them as targets for the newly created army of T-cells.

Finally, the patient would receive RACR/CAR, which doctors can use to tune the activity of the engineered T cells in the body with the help of FDA-approved drugs. One of those drugs is rapamycin, an immunosuppressant.

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Umoja banks $53M to develop triple-threat immunotherapies - FierceBiotech

Global Genes Honors Leaders, Advocates, and Innovators in Rare Disease From Around the World at the 2020 RARE Champion of Hope Celebration – Business…

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Global Genes, a leading rare disease patient advocacy organization, announces eight award recipients of diverse backgrounds and experiences through its annual Champion of Hope Awards, recognizing exceptional leaders and their efforts to inspire, advance progress, and create positive change for rare disease patients worldwide.

The challenges facing the rare disease community are extraordinary, even in the most ordinary of times, and 2020 has tested the resilience and determination of all patients, caregivers, advocates, and leaders in rare disease. This year, Global Genes honors a set of inspirational leaders whom have made a difference despite the odds, to the benefit of patients and caregivers around the world.

Were proud and grateful to celebrate these remarkable champions for the rare disease community, who offer hope to so many, said Craig Martin, interim CEO of Global Genes. We all need a little extra to keep us going these days, and the stories of these leaders will inspire you, whether you are part of the rare disease community or not.

This year, the celebration recognized those who made a significant impact in advocacy, industry, medical care, science, as well as up-and-coming rare disease leaders. With more than a hundred nominees, these awardees were selected:

In addition, this year Global Genes is introducing a RARE Founders Award, honoring an individual for the founding of an impactful organization in the rare disease community. The inaugural recipient of this award is Nicole Boice, founder of Global Genes and cofounder of RARE-X, a nonprofit organization focused on enabling global sharing of rare disease patient data to accelerate diagnosis and progress toward rare disease treatments and cures.

Success for founders comes from the dedicated work of many, especially in rare disease, where collaboration and a team approach are critical, said Boice. I am honored to receive this first Founders Award, and am excited that it will become an award to recognize future recipients that have created value in rare disease by being a trailblazer, by recognizing holes, gaps, and needs and then doing something about it.

It is an honor to be recognized by Global Genes as a RARE Champion honoree, said Timothy Walbert, CEO of Horizon Therapeutics, an advocacy organization that supports rare and rheumatic conditions. I applaud all that the organization has done and continues to do for the rare disease community, and I look forward to our ongoing partnership to address the challenges in the community as well as celebrate its successes.

Alexis Levine said, As someone who has personally been affected by rare disease, I am so intrinsically motivated to further the research that I sometimes forget about the impact of my work. Thank you, Global Genes, for reminding me that I am a RARE Champion of Hope; it is such an honor to have received this award!

Global Genes is grateful for the support of event sponsors: Alliance for Regenerative Medicine, Ultragenyx, Taysha Gene Therapies, Ionis Pharmaceuticals, and Horizon Therapeutics.

For more information, visit http://www.globalgenes.org.

About Global Genes

Global Genes is a 501(c)(3) nonprofit organization on a mission to connect, empower, and inspire the rare disease community. We provide hope for more than 400 million people affected by rare disease around the globe. To date, weve educated millions of people in more than 100 countries about rare disease, equipped patients and advocates with tools and resources, and provided hundreds of thousands of dollars in support for innovative patient impact programs. If you or someone you love has a rare disease or are searching for a diagnosis, contact Global Genes at 949-248-RARE, or visit the resource hub at Globalgenes.org.

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Global Genes Honors Leaders, Advocates, and Innovators in Rare Disease From Around the World at the 2020 RARE Champion of Hope Celebration - Business...

Biopharma Money on the Move: November 11-17 – BioSpace

A quick read of whose wallets got thicker in the biopharma industry,from largest to smallest.

D3 Bio

Industry-veteran George Chen left a seven-year career at AstraZeneca to launch his ownShanghai-based biotech, D3 Bio, with the support ofbig-nameinvestorslikeBoyu Capital, Matrix Partners China,SequoiaCapital China, Temasek and Wuxi AppTecs Corporate Venture Fund. At this point D3 is keeping its pipeline close to the chest.But Chensays its the approach thatsunique. The company will startwith insights from clinical development and a market assessment of unmet needs and use that to guide the clinical development path. D3 will use this$200 million Series Ato build out an R&D team focused on precision medicine in the realms of immunology and oncology.

Metagenomi

Unlocking the power of microbial evolution,Metagenomimines the worlds natural microbial environment to rapidly develop effective cures to treat incurable genetic diseases. A recent$65 million Series Awill help accelerate the expansion of its gene editing systems for therapies in oncology and genetic-related diseases.This means developing a vast database of gene editing capabilities to enable unprecedented therapeutic approaches. Working with visionary investors, such as Leaps by Bayer and Humboldt Fund, will allow us to deliver on our promise to partners and fuel the development of our own pipeline of innovative curative medicines, Thomas said in a statement.

AliveCor

AI companydisguisedas a medical device companyAliveCorpicked up$65 millionto ramp up speed on their remote cardiology platform. Amidst a pandemic, telehealth appointments have been increasingly necessary.AliveCorsECG will be strengthened withcardiologicaltelehealthservices as well as with detection and condition management services. To date, its products have served more than one million customers globally, recording over 85 million ECGs.AliveCorsKardiaMobiledevice is FDA-cleared and the most clinically validated personal ECG solution in the world.

Nereid Therapeutics

Birthed fromthe work of Clifford P.Brangwynne, Ph.D., Nereid hopes to translate the therapeutic promise of biomolecular condensates from physics to physicians.The biotech will take the$50 million Series Afunding andBrangwynnesproprietary technology enabling precise measurement, interrogationand control of phase separation in cells to develop their drug discovery platform. The platform holds potential to enable completely new approaches to discovering and developing therapeutics across a wide variety of diseases, focusing first on cancers and neurodegenerative disordersaffected by phase transitions.

KiraPharmaceuticals

Backed by$46 million in financingfrom biotech entrepreneur Peter Wirth and others,Kira launchedwith a mission of pioneering a new generation of complement-targeted therapies to treat immune-mediated diseases. With the financing in hand, Kira is aiming to have three assets in the clinic within the next 18 months. The companys most advanced program, P014, is a first-in-class biologic drug with a unique mechanism of action designed to inhibit both upstream and downstream complement targets.Former Sienna Biopharmaceuticals CEO Frederick Beddingfield will be at the helm.

Adagio Medical

Adagio is singing joyfully to the tune of a $42.5 million Series Eto supportthe commercialization of itsiCLASsystem.iCLASis Adagios intelligent Continuous Lesion Ablation Systempursuing both an Investigational Device Exemption trial and a European VT CE-Mark trial."Cardiac ablation is a large and growing market that faces significant challenges including disappointing clinical outcomes, long procedure times and unsatisfactory profitability for providers," saidTuan Huynh, ofArrowMark, one of the Series E investors joining Adagios board of directors. "We believe Adagio represents a unique opportunity to transform ablation therapy and look forward to partnering with Adagio's management team to support the company's growth and commitment to addressing challenges faced by physicians and their patients."

IniPharm

Founded in 2018 with a focus on liver disease,IniPharmbrought in$35 million with a Series Afinancing roundto take its lead program through to IND filing and into clinical trials.Theprogram targets the HSD17B13 gene, which according to CEO Brian Farmer, confers pretty amazing protection against liver disease.It doesnt appear to actually prevent the diseases causation, but slows progression to more serious illness by preventing inflammation, fibrosis and cirrhosis of the liver, which are the dangerous effects of liver disease.The potential for therapies that effectively target HSD17B13 activity is significant because it is linked to a broad spectrum of liver and related diseases, said Farmer.

InterVennBiosciences

InterVennlooks to ramp up their ability to discover biomarkersand design clinical trials with the help of a little AI. Funds from a$34 million Series Bwill expand its precision medicine platformfor cancer detection.InterVennstech platform targets carbohydrates known as glycans, looking for aberrant glycosylation of certain proteins, which are implicated in a variety of disease states, including inflammation.The company'sVOCALprojectis evaluating a blood test to determine ifan ovarian tumor is benign or malignant.It is also conducting research into colorectal cancer and kidney cancer, hunting for clinically actionable biomarkers that can be used for diagnosis, prognosis, and detection of cancer recurrence, as well as predictive tests to help choose appropriate drugs.

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Biopharma Money on the Move: November 11-17 - BioSpace

Elevation Oncology Announces $65M Series B Financing and Promotion of Founder Shawn M. Leland to Chief Executive Officer – PRNewswire

NEW YORK, Nov. 18, 2020 /PRNewswire/ --Elevation Oncology, a clinical-stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, announced today a Series B financing of $65 million led by new investors, venBio Partners and Cormorant Asset Management, and the promotion of Shawn M. Leland, PharmD, RPh, the Company's founder, to Chief Executive Officer. Additional participants in the financing include Boxer Capital of Tavistock Group, Janus Henderson, Samsara Biocapital, and Vivo Capital, as well as all of Elevation Oncology's existing investors:Aisling Capital, Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners.

Andrew Phillips, PhD from Cormorant Asset Management, and Richard Gaster, MD, PhD from venBio Partners, will join the Elevation Oncology Board of Directors in conjunction with the new financing.

"We welcome Andy and Rich to our Board of Directors and are encouraged by the support of a highly sophisticated investor group committed to helping us continue to pursue our mission," said Dr. Leland. "At the core of Elevation Oncology is the belief that patients deserve the right clinical team and the right genomic tests to match the right therapeutics to the unique genomic profile of each tumor. We look forward to continuing to work closely with our Board and Scientific Advisors to innovate and accelerate the development of precision oncology therapeutics to realize this vision."

Dr. Lelandfounded Elevation Oncology in July 2019, is a member of its Board of Directors, and previously served as the Company's Chief Business Officer. He has over a decade of experience in medical affairs and business development for the pharmaceutical/biotech industry, with a focus on building collaborations to realize the full potential of targeted and personalized therapeutics. He has been involved in global transactions totaling more than $450 million in upfront payments and milestone payments at Eli Lilly, ARIAD Pharmaceuticals, Argos Therapeutics and Verastem Oncology. Steve Elms, Managing Partner of Aisling Capital, who was serving as Interim CEO of Elevation Oncology, will remain Chair of the Company's Board of Directors.

"Shawn has been instrumental in the founding and success of Elevation Oncology to date," said Mr. Elms. "On behalf of the entire Board of Directors, I express our great confidence in the future of Elevation Oncology under Shawn's leadership. The proceeds raised with the Series B positions the Company well to deliver on our mission of developing precision therapeutics for patients with genomically defined cancers."

Elevation Oncology's lead development program, the Phase 2 CRESTONE study, is evaluating the HER3 monoclonal antibody seribantumab for the treatment of patients with tumors harboring an NRG1 gene fusion. The Company is actively evaluating opportunities for pipeline expansion, prioritizing targeted therapy approaches in tumor types defined by genomic driver alterations.

"The progress that Elevation Oncology has made in the short time since its founding to establish a strong scientific rationale and an accelerated development path for seribantumab in patients with tumors harboring an NRG1 gene fusion is quite impressive," said Dr. Gaster, Partner at venBio. "We see the progress to date as indicative of Elevation Oncology's long-term potential. I look forward to serving on Elevation's Board of Directors as the Company continues to advance its mission to match unique genomic test results with a purpose-built precision medicine approach to enable an individualized treatment plan for each patient."

"Elevation Oncology's commitment to innovation across the drug development lifecycle has drawn a distinguished group of collaborators who are able to broadly conduct genomic testing across the US, rapidly open up clinical trial sites, and ensure exemplary execution of the CRESTONE study," said Dr. Phillips, Managing Director at Cormorant. "I am very pleased to be joining the Company's Board of Directors to support the continued and expanded application of these efforts towards the efficient acquisition, development, and approval of new therapeutics for patients with genomically defined cancers."

Proceeds from the Series B financing will be used to fund the completion of enrollment in the CRESTONE study and other corporate development activities.

About Elevation OncologyElevation Oncology is founded on the belief that every patient with cancer deserves to know what is driving the growth of their disease and have access to therapeutics that can stop it. We make genomic tests actionable by selectively developing drugs to inhibit the specific alterations that have been identified as drivers of disease. Together with our peers we work towards a future in which each unique test result can be matched with a purpose-built precision medicine to enable an individualized treatment plan for each patient. Our lead candidate, seribantumab, inhibits tumor growth driven by NRG1 fusions and is currently being clinically tested in the Phase 2 CRESTONE study for patients with tumors of any origin that have an NRG1 fusion. Details on CRESTONE are available at http://www.NRG1fusion.com. For more information visit http://www.ElevationOncology.com.

About Seribantumab and NRG1 Gene FusionsSeribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are mutually exclusive with other known driver mutations and are considered a unique oncogenic driver event essential for tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, and sarcomas. In preclinical experiments, seribantumab prevents the activation of HER3 signaling in cells that harbor an NRG1 gene fusion. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to 847 patients across 12 Phase 1 and 2 studies, both as a monotherapy and in combination with various anticancer therapies. Seribantumab is currently being clinically tested in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the CRESTONE StudyClinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with any solid tumor that harbor an NRG1 fusion. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab specifically in patients with an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the US. For more information visit http://www.NRG1fusion.com.

Media ContactsElevation OncologyName: David Rosen, Argot PartnersPhone: +1 (716) 371-1125Email: [emailprotected]

SOURCE Elevation Oncology

elevationoncology.com

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Elevation Oncology Announces $65M Series B Financing and Promotion of Founder Shawn M. Leland to Chief Executive Officer - PRNewswire

Helixmith injects DPN therapy into 1st patient of P3 study – Korea Biomedical Review

Helixmith said Thursday the first enrolled patient has received its new gene therapy, Engensis (VM202), in phase 3-2 study of diabetic peripheral neuropathy (DPN).

The company plans to continue administering the drug to other participants, as it is screening many additional patients at five clinical trial centers. It is conducting DPN phase 3-2 trials, REGAIN-1A, at 15 clinical centers with 152 enrolled patients in the U.S.

Helixmith aims to meet two endpoints in the study.

The trial's primary efficacy endpoint is to compare changes in average daily pain scores between VM202 and placebo. The secondary endpoint is to reduce pain by 50 percent or more.

DPN is one of the most common complications of diabetes as 30 million U.S. adults have the disorder. Around 28.5 percent of diabetic patients develop DPN, and up to half of them may advance to painful DPN (PDPN).

Dr. Miguel Trevino, head of clinical trials at Innovative Research in which the first patient received VM202, noted that the existing treatments for DPN only relieve pain and show various adverse events with limited efficacy, inevitably leaving half of the patients in painful life.

"The delay of this phase 3 study was due to the preparation of clinical operation system and examining numerous items during the patient's screening process," Helixmith CEO Kim Sun-young said. "Our latest study will add considerable knowledge and evidence to support the optimal use of VM202 in patients needing therapeutic options."

The U.S. Food and Drug Administration recognized the scientific and clinical results of VM202 and designated it as RMAT (regenerative medicine advanced therapy) in 2018.

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Helixmith injects DPN therapy into 1st patient of P3 study - Korea Biomedical Review