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US snaps up first supplies of Regeneron’s COVID-19 antibody – – pharmaphorum

§ July 9th, 2020 § Filed under Genetically Modified Humans Comments Off on US snaps up first supplies of Regeneron’s COVID-19 antibody – – pharmaphorum

Hard on the heels of Regeneron moving its COVID-19 antibody cocktail into late-stage testing, the US government has agreed a deal to ramp up manufacturing and claim the first doses to be made.

A $450 million funding contract between Regeneron and the Trump administration will enable Regeneron to set up commercial-scale manufacturing of REGN-COV2 that could generate substantial numbers of doses by the autumn.

Assuming REGN-COV2 gets emergency use authorisation for COVID-19, all of those doses are allocated to the federal government. The move follows a similar agreement to secure access to the bulk of Gilead Sciences supplies of antiviral drug remdesivir between now and September.

REGN-COV2 is the first for a therapeutic under Operation Warp Speed, a federal programme that until now has focused only on coronavirus vaccines.

This week, Novavax claimed $1.6 billion in funding for its coronavirus vaccine NVX-CoV2373 from the scheme the largest award for any of the candidates in development in another agreement that guarantees the US access to all initial doses of the shot.

Regeneron has just announced it is starting a clinical trial of REGN-COV2 to prevent infection among uninfected people who have had close exposure to a COVID-19 patient, in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID).

At the same time, the antibody combination has also moved into the phase 2/3 portion of two adaptive phase 1/2/3 trials testing its ability to treat hospitalised and non-hospitalisedpatients with COVID-19.

The manufacturing deal with the Biomedical Advanced Research and Development Authority and the Department of Defense estimates that 70,000 to 300,000 therapeutic doses of the drug could be available by September, or 420,000 to 1.3 million prevention doses.

Both the Regeneron and Novavax deals will result in the medicines being delivered at no charge to COVID-19 patients in the US, according to the government, which will also handle distribution.

REGN-COV2 was developed by Regeneron based on tests in mice that have been genetically modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19.

The cocktail targets two components in the spike protein on SARS-CoV-2, the virus that causes COVID-19, with the aim of preventing attachment of the virus to host cells and interrupting infection.

A similar approach has been used in the development of Regenerons Ebola candidate REGN-EB3, which is under review at the FDA with a verdict due in October.

We made the decision early on to begin large-scale manufacturing at our own risk in order to ensure that product would be available immediately if our clinical trials prove successful and an emergency use authorization is granted, said Regenerons CEO Leonard Schleifer.

This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic.

Regeneron has also been working with partner Sanofi to try to repurpose their anti-IL-6 antibody Kevzara (sarilumab) as a COVID-19 treatment, but that has yielded disappointing results in patients requiring mechanical ventilation.

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Editorial: The cost of truth too high for Bayer – Capital Press

§ July 9th, 2020 § Filed under Genetically Modified Humans Comments Off on Editorial: The cost of truth too high for Bayer – Capital Press

Two recent developments in separate court cases involving glyphosate herbicides deserve comment.

Glyphosate, known by the trade name Roundup, has been used as an herbicide for 40 years. More recently, it has also been used in conjunction with a handful of genetically modified Roundup Ready crops that that allow farmers to kill weeds without killing the crops.

The nexus between the cases is a paper written in 2015 by the World Health Organizations International Agency for Research on Cancer classifying glyphosate as probably carcinogenic to humans.

The finding runs counter to what the Environmental Protection Agency, the European Unions Glyphosate Task Force, the German Federal Institute of Risk Assessment and other regulatory and research agencies have concluded.

In reaching its findings, IARC did not conduct original research. It evaluated available literature.

But based on the finding, the state of California in 2017 added glyphosate to its list of chemicals known to cause cancer or birth defects or other reproductive harm. State Proposition 65 requires warning labels for products containing chemicals known to the state to cause cancer.

Plaintiffs sued, arguing the state had ignored the findings of hundreds of studies and the conclusions of regulatory agencies around the world.

U.S. District Judge William Shubb last month agreed, granting summary judgment and issued a permanent injunction against the warning.

In 2018 Shubb issued a preliminary injunction against the state, noting that basing a warning on the finding of one organization that is disputed by other regulatory bodies was misleading. In his final ruling, Shubb said the statement that glyphosate is known to the state of California to cause cancer is misleading. Every regulator of which the court is aware, with the sole exception of the IARC, has found that glyphosate does not cause cancer or that there is insufficient evidence to show that it does.

Also last month Bayer, the owner of Monsanto, announced it would pay up to $10.9 billion to settle litigation involving Roundup.

The company faces more than 125,000 lawsuits from plaintiffs, using the WHO finding as evidence, who allege the herbicide caused their cancer.

Three California juries have found in separate cases that Roundup caused plaintiffs cancers. Last summer a jury in California ordered the company to pay a couple $2 billion.

It is financially reasonable when viewed against the significant financial risks of continued, multi-year litigation and the related impacts to our reputation and to our business, Bayer CEO Werner Baumann said in a statement concerning the settlement.

Bayers decision is particularly interesting coming on the heels of Shubbs ruling, which bolsters its case.

Despite a dearth of evidence, sympathetic juries are willing to help cancer victims by tapping into Bayers deep pockets. The cost of litigating 125,000 cases through appeals would easily surpass what Bayer has agreed to pay.

Shubbs ruling was based on the facts. Bayers decision was based solely on the financial calculus. The price of truth, unfortunately, is just too high.

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Editorial: The cost of truth too high for Bayer - Capital Press

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New swine flu with pandemic potential identified by China researchers – The Guardian

§ July 5th, 2020 § Filed under Genetically Modified Humans Comments Off on New swine flu with pandemic potential identified by China researchers – The Guardian

Warning comes after researchers took 30,000 nasal swabs from pigs between 2011 and 2018. Photograph: Alamy Stock Photo

Researchers in China have discovered a new type of swine flu that is capable of triggering a pandemic, according to a study in the US science journal PNAS, although experts said there is no imminent threat.

Named G4, it is genetically descended from the H1N1 strain that caused a pandemic in 2009.

It possesses all the essential hallmarks of being highly adapted to infect humans, said the authors, scientists at Chinese universities and Chinas Center for Disease Control and Prevention, in the study published on Monday.

Between 2011 and 2018, researchers took 30,000 nasal swabs from pigs in slaughterhouses in 10 Chinese provinces and in a veterinary hospital, allowing them to isolate 179 swine flu viruses.

The majority were of a new kind that has been dominant among pigs since 2016.

The researchers then carried out various experiments including on ferrets, which are widely used in flu studies because they experience similar symptoms to humans.

G4 was observed to be highly infectious, replicating in human cells and causing more serious symptoms in ferrets than other viruses do.

Tests also showed that any immunity humans gain from exposure to seasonal flu does not provide protection from G4.

More than one in 10 swine workers in the new study had already been infected, according to antibody blood tests which showed exposure to the virus.

The tests also showed that as many as 4.4% of the general population also appeared to have been exposed.

The virus has therefore already passed from animals to humans but there is no evidence yet that it can be passed from human to human the scientists main worry.

The World Health Organization (WHO) will read the Chinese study carefully, spokesman Christian Lindmeier told a Geneva briefing on Tuesday, saying it was important to collaborate on findings and keep tabs on animal populations.

It also highlights we cannot let our guard down on influenza and need to be vigilant and continue surveillance even in the coronavirus pandemic, he added.

Chinese Foreign Ministry spokesman Zhao Lijian told a daily news conference on Tuesday that China was closely following developments. We will take all necessary measures to prevent the spread and outbreak of any virus, he said.

The study highlights the risks of viruses crossing the species barrier into humans, especially in densely populated regions in China, where millions live close to farms, breeding facilities, slaughterhouses and wet markets.

The current coronavirus sweeping the world is believed to have originated in horseshoe bats in southwest China and could have spread to humans via a seafood market in the central city of Wuhan, where the virus was first identified.

It is of concern that human infection of G4 virus will further human adaptation and increase the risk of a human pandemic, the researchers wrote.

The authors called for urgent measures to monitor people working with pigs.

James Wood, head of the department of veterinary medicine at Cambridge University, said: The work comes as a salutary reminder that we are constantly at risk of new emergence of zoonotic pathogens and that farmed animals with which humans have greater contact than with wildlife may act as the source for important pandemic viruses.

A zoonotic infection is caused by a pathogen that has jumped from a non-human animal into a human.

Although it is capable of infecting humans, there is no imminent risk of a new pandemic, said Carl Bergstrom, a biologist at the University of Washington. Theres no evidence that G4 is circulating in humans, despite five years of extensive exposure, he said on Twitter. Thats the key context to keep in mind.

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How a Chinese firm with Canadian ties jumped to the front of the coronavirus vaccine race – Financial Post

§ July 5th, 2020 § Filed under Genetically Modified Humans Comments Off on How a Chinese firm with Canadian ties jumped to the front of the coronavirus vaccine race – Financial Post

When a group of Chinese scientists gathered over barbecue and beer in a Toronto backyard a decade ago, talk drifted to their homelands vaccines, which had long lagged the developed world on quality and safety. Four of them decided to act.

They left top positions at global pharmaceutical companies in Canada to set up a biotechnology firm half a world away in Tianjin, China, hoping to produce vaccines on par with Western countries. Now, that company, CanSino Biologics Inc., is vaulting into the global spotlight as connections on both sides of the Pacific make it one of the front-runners in the race for a coronavirus vaccine.

CanSinos Chinese-born chief executive officer, Yu Xuefeng, formerly a senior executive at drugmaker Sanofis Canadian vaccine operations, has maintained relationships in Canada and China even as geopolitical disagreements polarize both countries. Yu has boosted his firms scientific prowess by tying up with the Canadian governments largest research organization. At home, hes worked with a prominent Chinese military scientist, first on an Ebola vaccine and now on CanSinos experimental coronavirus shot.

In May, CanSino became the first globally to publish a full scientific study on its early human trials, an important step because it allows researchers worldwide to assess a vaccines potential.

The company which is yet to generate revenue and logged a US$22 million loss last year has so far kept up with, and occasionally even outpaced, Western pharmaceutical giants with the speed of its initial coronavirus vaccine trials. The research is still too nascent to know if the shot from CanSino, or indeed any company, will provide the magic bullet countries are seeking to open up while the pandemic rages. But CanSinos inroads show Chinas young biotechnology industry is becoming a global contender, and a powerful tool for President Xi Jinping.

CanSino deserves credit for the speed with which they pushed the vaccine through pre-clinical studies and human testing, said Wang Ruizhe, a pharmaceutical industry analyst at Capital Securities Corp. in Shanghai. It tells you something about their ability to mobilize and leverage the resources that it takes to get all these done. The resources required here are substantial.

A spokesperson for the Chinese company, citing media reports in May, said Canadian Prime Minister Justin Trudeau is supportive of the Canadian researchers working on clinical trials for a coronavirus vaccine with CanSino.

Chinas pharmaceutical industry has been dogged by safety incidents and quality scandals. But in recent years, parts of it have grown more advanced as hundreds of Chinese scientists trained in the West have come home.

Called hai gui, or sea turtles, these returnees have capitalized on relationships and expertise gained in countries like the U.S. and Canada, and created new companies. CanSinos CEO Yu 57, who has a doctorate from Canadas McGill University in microbiology and was the head of vaccine development and production at Sanofi Pasteur in Canada belongs to this new breed of executives.

In the prospectus for CanSinos 2019 public offering in Hong Kong, Yu described the difficult choices he and his colleagues made in forging their new path back home in China.

Most of our families stayed in Canada, and we could only see them a few times a year, he wrote. When you think about your young kids and teenagers growing up without dads, when you know your wife had to shovel out of 10 inches of deep snow early morning in -20C wind chill all by herself those were the tough moments.

The name CanSino represents the Chinese characters for health, hope and promises, while in English its a combination of Canada and China. Besides Yu, other top officials at the firm have Canadian connections. Chief Scientific Officer Zhu Tao was also a senior scientist at Sanofi Pasteur in Canada. The companys success has relied on threading the needle between both nations.

In February 2014, about five years after returning to China, Yu licensed a technology from the National Research Council of Canada called HEK 293 cell lines, which is required to produce large quantities of a vaccine reliably. That science went on to partly underpin CanSinos viral vector technology.

An advanced way to make a vaccine, a viral vector is a genetically modified virus that is no longer harmful to humans, but can serve as a vehicle to carry the genes of another germ to prepare the immune system for attack. Few Chinese companies had that technology in 2014, when a Chinese army researcher called Chen Wei began looking for viral vector expertise to produce a vaccine amid Africas Ebola outbreak.

A major general in Chinas Peoples Liberation Army, Chen headed the Institute of Biotechnology at the countrys Academy of Military Medical Sciences. She went on to work with CanSino to develop an Ebola vaccine that in 2017 was approved in China for emergency use and national stockpiling.

Chen has star status in China. In a nationalistic movie called Wolf Warrior II, the character of a scientist who develops a vaccine against a deadly African virus is believed to be modelled on her. She developed a therapy used by Chinese health workers during the SARS outbreak of 2003.

Chen is also known for a singular dedication to her work. In a 2004 interview with state-run CCTV, she said she presented her findings on the SARS therapy to Beijings municipal authorities after dosing her four-year-old son with it for two months because she was so sure about her research.

CanSinos long-running relationship with Chen paid off again this year. CanSino and her team raced through pre-clinical studies on the coronavirus vaccine called Ad5-nCoV. They secured Beijings help on everything from isolating virus strains to animal testing. Chen and the institute couldnt be reached for comment.

The team started human clinical trials in Wuhan, the Chinese city where the coronavirus first emerged, on March 16. Massachusetts-based Moderna Inc., seen as one of the best contenders to produce an American vaccine, started its tests in the U.S. the same day. Less than a month later, CanSino began the second phase of wide-scale human trials. On May 22, when it published a study in the medical journal the Lancet, the results were mixed: The shot appeared to be safe and generated some immune response, but there were shortcomings.

Viral vector technology can have limitations when some people already have pre-existing immunity to the vector virus used to create the vaccine. This was the case for the adenovirus a genetically-altered cold-causing virus which CanSino used for its vaccine. Many of those with pre-existing adenovirus immunity showed diminished response to its coronavirus shot in the Lancet study.

For upcoming trials in Canada, CanSino has added a booster shot for some participants to attempt to address the lacklustre response from those with pre-existing immunity to the adenovirus vector, according to a person with knowledge of its trial design who didnt want to be named discussing information thats not public.

CanSino is in the game and its about where the other so-called leaders are, said William Haseltine, a former Harvard University HIV researcher. Whether anybody will cross the finish line where we ever can see safety data that we would like to see is unknown.

CanSino is in the game and it's about where the other so-called leaders are

Final-stage trials could yet stymie CanSinos outsized ambitions. Its Ebola vaccine was approved on an emergency basis after two stages of human testing, but the company never completed the final phase as the epidemic petered out in Africa. CanSino doesnt generate much revenue because most of its products, including two late-stage meningitis vaccines, are still in development.

The company has received some funding from Beijing for the coronavirus vaccine, although the amount isnt large, the person familiar with its trials said.

CanSinos founders ties with Canada are once again proving fortuitous as it looks to conduct Phase III tests on its vaccine. Still, there could be challenges in conducting the sizable studies required in the final stages if new coronavirus infections continue to taper in Canada. China has largely stamped out its outbreak.

Researchers at Dalhousie Universitys Canadian Center for Vaccinology, who are leading the clinical trials, have said they hope to start Phase III studies of the CanSino shot as early as this fall. Canadas National Research Council said if the vaccine candidate is approved by authorities there, it has the option to produce doses of the vaccine for emergency pandemic use in Canada. (CanSino is responsible for funding its own trials, Health Canada, the governments health agency, said in an email.)

Meanwhile, Chinas reputation in Canada already damaged by Beijings reaction to the arrest of Huawei Technologies Co.s chief financial officer in Vancouver has been dealt a further blow by the pandemic and perceptions China hid the virus initially. That could fuel more scrutiny of CanSino and its vaccine in Canada.

Other companies are also racing ahead. Moderna is set to test its vaccine among 30,000 people in the U.S. in July, while an early-stage trial of a Pfizer Inc. and BioNtech SE shot showed its safe and prompted patients to produce antibodies against the coronavirus. A vaccine co-developed by the University of Oxford and AstraZeneca Plc also started the final stage of human testing in Brazil in June.

At home, state-run vaccine developer China National Biotec Group Co. has secured approval from health authorities in the U.A.E. to conduct Phase III testing for the two shots it developed against the coronavirus. Beijing-based Sinovac Biotech Ltd. has inked a deal to do final tests in Brazil, too. The outcome for all of these companies and CanSino will only be known once this ultimate stage of scientific studies is complete.

The viral vector CanSino is using is a relatively safe approach compared to other techniques but its hard to make a call on efficacy for now, said Wang, the Shanghai-based analyst. Theres no shortage of histories where promising efforts made it to the last stage of testing only to see things fall apart.

Bloomberg.com

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How a Chinese firm jumped to the front of the virus vaccine race – Economic Times

§ July 2nd, 2020 § Filed under Genetically Modified Humans Comments Off on How a Chinese firm jumped to the front of the virus vaccine race – Economic Times

When a group of Chinese scientists gathered over barbecue and beer in a Toronto backyard a decade ago, talk drifted to their homelands vaccines, which had long lagged the developed world on quality and safety. Four of them decided to act.

They left top positions at global pharmaceutical companies in Canada to set up a biotechnology firm half a world away in Tianjin, China, hoping to produce vaccines on par with Western countries. Now, that company, CanSino Biologics Inc., is vaulting into the global spotlight as connections on both sides of the Pacific make it one of the front-runners in the race for a coronavirus vaccine.

CanSinos Chinese-born chief executive officer, Yu Xuefeng, formerly a senior executive at drugmaker Sanofis Canadian vaccine operations, has maintained relationships in Canada and China even as geopolitical disagreements polarize both countries. Yu has boosted his firms scientific prowess by tying up with the Canadian governments largest research organization. At home, hes worked with a prominent Chinese military scientist, first on an Ebola vaccine and now on CanSinos experimental coronavirus shot.

In May, CanSino became the first globally to publish a full scientific study on its early human trials, an important step because it allows researchers worldwide to assess a vaccines potential.

The company -- which is yet to generate revenue and logged a $22 million loss last year -- has so far kept up with, and occasionally even outpaced, Western pharmaceutical giants with the speed of its initial coronavirus vaccine trials. The research is still too nascent to know if the shot from CanSino, or indeed any company, will provide the magic bullet countries are seeking to open up while the pandemic rages. But CanSinos inroads show Chinas young biotechnology industry is becoming a global contender, and a powerful tool for President Xi Jinping.

CanSino deserves credit for the speed with which they pushed the vaccine through pre-clinical studies and human testing, said Wang Ruizhe, a pharmaceutical industry analyst at Capital Securities Corp. in Shanghai. It tells you something about their ability to mobilize and leverage the resources that it takes to get all these done. The resources required here are substantial.

A spokesperson for the Chinese company, citing media reports in May, said Canadian Prime Minister Justin Trudeau is supportive of the Canadian researchers working on clinical trials for a coronavirus vaccine with CanSino.

Chinas pharmaceutical industry has been dogged by safety incidents and quality scandals. But in recent years, parts of it have grown more advanced as hundreds of Chinese scientists trained in the West have come home.

Called hai gui, or sea turtles, these returnees have capitalized on relationships and expertise gained in countries like the U.S. and Canada, and created new companies. CanSinos CEO Yu -- 57, who has a doctorate from Canadas McGill University in microbiology and was the head of vaccine development and production at Sanofi Pasteur in Canada -- belongs to this new breed of executives.

In the prospectus for CanSinos 2019 public offering in Hong Kong, Yu described the difficult choices he and his colleagues made in forging their new path back home in China.

Most of our families stayed in Canada, and we could only see them a few times a year, he wrote. When you think about your young kids and teenagers growing up without dads, when you know your wife had to shovel out of 10 inches of deep snow early morning in -20C wind chill all by herself those were the tough moments.

Both Sides The name CanSino represents the Chinese characters for health, hope and promises, while in English its a combination of Canada and China. Besides Yu, other top officials at the firm have Canadian connections. Chief Scientific Officer Zhu Tao was also a senior scientist at Sanofi Pasteur in Canada. The companys success has relied on threading the needle between both nations.

In February 2014, about five years after returning to China, Yu licensed a technology from the National Research Council of Canada called HEK 293 cell lines, which is required to produce large quantities of a vaccine reliably. That science went on to partly underpin CanSinos viral vector technology.

An advanced way to make a vaccine, a viral vector is a genetically modified virus that is no longer harmful to humans, but can serve as a vehicle to carry the genes of another germ to prepare the immune system for attack. Few Chinese companies had that technology in 2014, when a Chinese army researcher called Chen Wei began looking for viral vector expertise to produce a vaccine amid Africas Ebola outbreak.

Ebola Vaccine A major general in Chinas Peoples Liberation Army, Chen headed the Institute of Biotechnology at the countrys Academy of Military Medical Sciences. She went on to work with CanSino to develop an Ebola vaccine that in 2017 was approved in China for emergency use and national stockpiling.

Chen has star status in China. In a nationalistic movie called Wolf Warrior II, the character of a scientist who develops a vaccine against a deadly African virus is believed to be modeled on her. She developed a therapy used by Chinese health workers during the SARS outbreak of 2003.

Chen is also known for a singular dedication to her work. In a 2004 interview with state-run CCTV, she said she presented her findings on the SARS therapy to Beijings municipal authorities after dosing her four-year-old son with it for two months because she was so sure about her research.

CanSinos long-running relationship with Chen paid off again this year. CanSino and her team raced through pre-clinical studies on the coronavirus vaccine -- called Ad5-nCoV. They secured Beijings help on everything from isolating virus strains to animal testing. Chen and the institute couldnt be reached for comment.

Mixed Results The team started human clinical trials in Wuhan, the Chinese city where the coronavirus first emerged, on March 16. Massachusetts-based Moderna Inc., seen as one of the best contenders to produce an American vaccine, started its tests in the U.S. the same day. Less than a month later, CanSino began the second phase of wide-scale human trials. On May 22, when it published a study in the medical journal the Lancet, the results were mixed: The shot appeared to be safe and generated some immune response, but there were shortcomings.

Viral vector technology can have limitations when some people already have pre-existing immunity to the vector virus used to create the vaccine. This was the case for the adenovirus -- a genetically-altered cold-causing virus -- which CanSino used for its vaccine. Many of those with pre-existing adenovirus immunity showed diminished response to its coronavirus shot in the Lancet study.

In the Game For upcoming trials in Canada, CanSino has added a booster shot for some participants to attempt to address the lackluster response from those with pre-existing immunity to the adenovirus vector, according to a person with knowledge of its trial design who didnt want to be named discussing information thats not public.

CanSino is in the game and its about where the other so-called leaders are, said William Haseltine, a former Harvard University HIV researcher. Whether anybody will cross the finish line where we ever can see safety data that we would like to see is unknown.

Final-stage trials could yet stymie CanSinos outsized ambitions. Its Ebola vaccine was approved on an emergency basis after two stages of human testing, but the company never completed the final phase as the epidemic petered out in Africa. CanSino doesnt generate much revenue because most of its products, including two late-stage meningitis vaccines, are still in development.

The company has received some funding from Beijing for the coronavirus vaccine, although the amount isnt large, the person familiar with its trials said.

Phase III CanSinos founders ties with Canada are once again proving fortuitous as it looks to conduct Phase III tests on its vaccine. Still, there could be challenges in conducting the sizable studies required in the final stages if new coronavirus infections continue to taper in Canada.

Researchers at Dalhousie Universitys Canadian Center for Vaccinology, who are leading the clinical trials, have said they hope to start Phase III studies of the CanSino shot as early as this fall. Canadas National Research Council said if the vaccine candidate is approved by authorities there, it has the option to produce doses of the vaccine for emergency pandemic use in Canada. (CanSino is responsible for funding its own trials, Health Canada, the governments health agency, said in an email.)

Meanwhile, Chinas reputation in Canada -- already damaged by Beijings reaction to the arrest of Huawei Technologies Co.s chief financial officer in Vancouver -- has been dealt a further blow by the pandemic and perceptions China hid the virus initially. That could fuel more scrutiny of CanSino and its vaccine in Canada.

Other companies are also racing ahead. Moderna is set to test its vaccine among 30,000 people in the U.S. in July, while an early-stage trial of a Pfizer Inc. and BioNtech SE shot showed its safe and prompted patients to produce antibodies against the coronavirus. A vaccine co-developed by the University of Oxford and AstraZeneca Plc also started the final stage of human testing in Brazil in June.

At home, state-run vaccine developer China National Biotec Group Co. has secured approval from health authorities in the U.A.E. to conduct Phase III testing for the two shots it developed against the coronavirus. Beijing-based Sinovac Biotech Ltd. has inked a deal to do final tests in Brazil, too. The outcome for all of these companies -- and CanSino -- will only be known once this ultimate stage of scientific studies is complete.

The viral vector CanSino is using is a relatively safe approach compared to other techniques but its hard to make a call on efficacy for now, said Wang, the Shanghai-based analyst. Theres no shortage of histories where promising efforts made it to the last stage of testing only to see things fall apart.

--With assistance from Yunong Wu.

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How a Chinese firm jumped to the front of the virus vaccine race - Economic Times

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The Rabbit Outbreak – The New Yorker

§ July 2nd, 2020 § Filed under Genetically Modified Humans Comments Off on The Rabbit Outbreak – The New Yorker

Most countries affected by the virus began offering the vaccine, and within a few years the spread appeared to have been tamped down. But, in 2010, rabbits in France began dying of what turned out to be a mutated version of the virus. The vaccine for the original virus was ineffective against the new strain; this was RHDV2. Soon, it was rampant throughout Europe and Australia. In England, the spread was so vigorous that parents were advised not to let their children bury their dead rabbits in the garden, because, while comforting to children, the practice may help circulate rabbit virus. The mortality rate of the new variant appeared to be slightly lower than that of the original, and at first this seemed like good news. But, in fact, RHDV2 was even more efficient at spreading, in the sense that more infected rabbits were surviving, and, because they might not show symptoms, they werent being isolated, and passed along the disease. Vaccines guarding against RHDV2 were developed. (In some cases, they were produced in combination with the vaccine that prevents RHDV1.) By 2016, they were available across Europe, and vaccinating rabbits became common.

The new variant, like the original, at first seemed to stay away from the United States, except for a few isolated cases. But, in July, 2019, a pet Norwegian Dwarf male on Orcas Island, near Seattle, died with a bloody nose. A veterinarian who saw the rabbit in a clinic was aware of RHD, and knew that bloody noses are a symptom, so she called the Washington State Department of Agriculture to report the death. Susan Kerr, an education and outreach specialist there, was alarmed, because she knew there was an RHDV2 outbreak in British Columbia, so the clinic sent the rabbits body to a lab for a necropsy.

While waiting for those results, Kerrs co-workers got calls from a number of people on San Juan Island, about a dozen miles southwest of Orcas Island. San Juan is famous for its rabbits. In the nineteen-thirties, a commercial breeder there went out of business, and released three thousand rabbits into the wild. They multiplied and became a tourist attraction, and rabbit hunting on the island was so celebrated that, in the sixties, Sports Illustrated ran a story about it, titled Hippity Hop and Away We Go. By 1971, San Juan Island, which covers just fifty-five square miles, was home to an estimated one million feral domestic rabbits.

Kerrs department also received calls from a few nearby islands reporting rabbit deaths. Soon, the lab confirmed that the Orcas Island rabbit had died of RHDV2. Kerr then got news that most of the hundred and forty-five rabbits at a facility on the Olympic Peninsula, across Puget Sound from the islands, had died in a three-week period. Their symptoms sounded like RHDV2; the virus was travelling. As a precaution, rabbits and rabbit products were banned from the ferry system that services Puget Sound.

A colleague of Kerrs posted about the outbreak on an online animal-health newsletter, and was inundated with requests from owners who knew that a vaccine existed, asking how they could get their rabbits inoculated. But the vaccine for RHDV2, like the vaccine for the original virus, was available only overseas. No companies had a license to distribute it in the United States.The U.S.D.A. opposed importing it, except for limited special circumstances. One problem is that attempts to produce the vaccine on cell lines in a laboratory have failed. Merck produces a vaccine in cells, but its a live, genetically modified vaccine, which is not permitted in this country. The other companies that currently manufacture the RHD vaccine produce it by infecting live rabbits with RHD. When those rabbits die, vaccines are made from their livers. According to a spokesperson for Filavie, one rabbit yields several thousand vaccine doses.

The U.S.D.A. also maintained that vaccinating some rabbits would make it difficult to distinguish between sick rabbits and those with antibodies produced by the vaccine, although, since most sick rabbits died, the distinction would actually be very clear. In the rabbit community, the departments mulishness was infuriating. Some people said that it reflected a bad attitude toward rabbits, seeing them as disposable goods, easily replaced. Others thought that the department simply didnt want to manage all the paperwork required to bring a vaccine from overseas, or just didnt want to acknowledge that the virus was present.

The U.S.D.A. finally agreed to consider requests for the emergency importation of limited amounts of the vaccine, but only if veterinarians applied first through their state veterinarians. Leaving the question of the vaccine to the states, though, meant that there could be fifty different decisions on ita patchwork of guidelines for a disease that would travel with no regard to borders. A number of veterinarians said that they were interested in applying to import the vaccine, but, once they discovered the headaches involved, most of them gave up. Alicia McLaughlin, one of the medical directors of the Center for Bird and Exotic Animal Medicine, in Bothell, Washington, was the first veterinarian in the country to obtain the vaccine, which she ordered from Filavie. She, too, had heard about the RHDV2 outbreak in British Columbia, so she started researching how to get the vaccine, and compiled a list of several hundred clients who were requesting it. I knew the virus would get here, she said recently. Once it was in British Columbia, it was just a matter of time.

She applied to the Washington state veterinarian; was shuttled for a month between the state agriculture department and the U.S.D.A.; had to manage language and time-zone barriers; then had to hire a customs broker to shepherd the vaccines across borders. Finally, more than four months after she applied, she received five hundred doses of Filavac VHDKC+V, which protects against both RHDV1 and RHDV2. By the time McLaughlin was finally able to administer the vaccine to her clients, in April, concerns over COVID-19 had meant that she could offer only curbside service, and had to struggle to find personal protective equipment, which she needed, because she was interacting with patients and handling their animals.

Around this same time, the Center for Avian and Exotic Medicine, in Manhattan, had been thoroughly sanitized after its RHDV2 outbreak. To be absolutely sure that it was uncontaminated, Alix Wilson brought two rabbits to live at the clinic as sentinels. Because the virus is so contagious, the rabbits would almost certainly come down with RHDV2 if it was still in the facility. No one wants to bring animals in to die, she said. But its one sure way in veterinary medicine to prove that a cleanup has worked. The rabbits survived. Wilson then applied to import the vaccine, and received a letter from the U.S.D.A. saying that without evidence of widespread infection the risk was low, especially since, as the department maintained, household rabbits have no contact with others.

Some of the clinics clients were furious that there had been a few days delay between the first rabbit deaths and when the clinic put the word out about the diagnosis. According to Wilson, the clinic couldnt have done it any faster, since it had to wait to hear the results of the necropsy. The fact is that even the mention of RHD panics rabbit owners. Thousands have joined a Facebook group to exchange knowledge, vent, and worry. Useful information is interlaced with dread. A chief concern is whether its safe to let a veterinarian know if you think that your rabbit might have RHD, since the veterinarian is obliged to report it to the state veterinarian. The fearwhich, according to the New Mexico state veterinarian, Ralph Zimmerman, is mostly justifiedis that, if your rabbit does have the virus and you have other rabbits, you will be required to depopulate; that is, you will have to euthanize them. There is also persistent chatter that the vaccine actually caused the disease, as part of a global plot to rid the world of rabbits. Recently, a member of the Facebook group proposed that rabbit owners sue Australia, perhaps conflating the past use of myxoma virus there with the outbreak of RHD. No, another member replied, we cannot sue Australia.

As the clinic in New York was reopening, thirty dead rabbits were found near Fort Bliss, Texas. An unusual number of dead rabbits were also found in Arizona, New Mexico, and Colorado. Along with pet rabbits and a small rabbit-meat industry, the Southwest has large populations of wild black-tailed jackrabbits and cottontails. Although they resemble domestic rabbits, these are different species entirely; they cant interbreed with domestic rabbits, nor are they susceptible to all of the same diseases. Wild rabbits seemed immune to RHDV1. But RHDV2 made a cross-species leap and, in March, jackrabbits and cottontails throughout the Southwest began dying in droves. Ive gotten reports that its in the thousands, Zimmerman said recently. Im sure next Ill be hearing that its in the tens of thousands. He has scraped together money from New Mexicos state budget to import five hundred doses of the vaccine, which he will distribute to veterinarians around the state. He assumes that those doses will go to high-dollar breeding animals.

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The Rabbit Outbreak - The New Yorker

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Regeneron v Kymab and the effect of claim scope on the requirement of sufficiency of disclosure – Lexology

§ June 27th, 2020 § Filed under Genetically Modified Humans Comments Off on Regeneron v Kymab and the effect of claim scope on the requirement of sufficiency of disclosure – Lexology

Earlier this year, the UK Supreme Court (UKSC) heard pleadings on behalf of Kymab Ltd (Kymab) and Regeneron Pharmaceuticals, Inc (Regeneron) in their ongoing dispute over patents relating to transgenic mice capable of producing antibodies suitable for use in humans. In a judgment handed down today (24 June 2020), the UKSC overturned an earlier Court of Appeal ruling and allowed Kymabs appeal on the basis the patents asserted by Regeneron were invalid for reasons of insufficiency.

In this article, we summarise the background of the case and discuss what this could mean for the requirement of sufficiency of disclosure in the UK. The take home message for your patent filing strategy is this: when drafting applications, consider in detail the scope of each feature of your claims. If a feature is both (1) broad and (2) responsible for the advantages of the invention, consider including (optional) language in your specification that limits the breadth of that feature if the skilled person cannot put the invention into practice across its whole scope based on their common general knowledge.

For a detailed analysis, read on.

How did we get here?

The case relates to two of Regenerons Patents, European Patent (UK) No 1360287 and its divisional European Patent (UK) No 2264163 ("the 287 patent" and "the 163 patent", respectively).

Regeneron initially brought an infringement claim against Kymab, who counterclaimed for invalidity. In the first instance, Henry Carr J ruled the patents were invalid due to insufficiency. However, if the patents were found to be valid, Kymabs various strains of transgenic mice would have infringed claims 5 and 6 of the `287 patent and claim 1 of the `163 patent.

Regeneron appealed the finding of invalidity and Kymab cross-appealed the finding of infringement. The Court of Appeal overturned the original decision and found the patents valid as well as dismissing Kymabs cross appeal, therefore finding that the patents were also infringed. Kymab was granted leave to appeal to the Supreme Court. The injunctive relief granted by the Court has been the subject of many a blog post, given it was stayed pending the outcome of the second appeal, but that is outside the scope of this article.

Todays judgment reverses the Court of Appeals finding, revoking both of the patents for not meeting the requirement of sufficiency of disclosure.

The technological background

The technological background is highly complex. In summary, the patents in general relate to transgenic mice for the production of human antibodies. Antibodies (aka immunoglobulins) are a key part of the immune system that target foreign proteins known as antigens. The structure of an antibody is traditionally depicted as having a Y-formation, and all antibodies share a characteristic unit structure made up of two identical heavy chains and two identical light chains. These heavy and light chains are themselves made up of segments known as the variable (V), diversity (D), joining (J) and constant (C) gene segments. The heavy chain of an antibody has V, D, J and C segments. The light chains have only V, J and C segments.

V, D, and J segments (in the case of the heavy chain) and the V and J segments (in the case of the light chain) are joined together at the DNA level in a process known as VDJ recombination, or somatic gene rearrangement. The way in which the segments are combined determines the specificity of the antibody (i.e. to what antigen or antigens the antibodies bind). Following VDJ recombination, the VDJ sequences undergo further rounds of mutation to improve the affinity of the antibodies for their antigen, in a process known as somatic hypermutation.

The eventual result is the production of a huge array of different antibodies from a relatively small pool of starting materials. This process is crucial to enable the production of antibodies that specifically bind a wide variety of antigens with high affinity.

A complication is that the V, D, J and C gene segments are different in different animals. So, although it is relatively easy to produce mouse antibodies to an antigen by inoculating the mouse with the antigen and allowing the murine immune system to generate antibodies that target the antigen, those antibodies are not suitable for use in humans, because a human host would react to the mouse antibodies themselves as foreign proteins. This is known as the human anti-mouse antibody (HAMA) response. The inventors of the 287 and 163 patents aimed to solve this HAMA problem when using mice to produce antibodies for later use in humans.

Transgenics is the term used to describe the introduction of DNA fragments encoding functional gene products from one species into the germ line of a different species. In transgenics, one can take (for example) human antibody genes and insert them into a mouse genome. This method can be used to create antibodies in a mouse that can later be administered to a human without inducing a HAMA response, because human genes were used to make the antibodies.

The insertion of the entire human immunoglobulin genes (i.e. all of the V, D, J and C segments) had already been achieved prior to the filing of the patents at issue here. However, the immune response in these mice was poor, and the mice were deemed immunologically sick. To avoid this problem, the patents proposed what is known as the reverse chimeric locus, in which only the mouse V, D and J segments are replaced with the human counterparts, and the mouse constant (C) regions are retained. The provision of mice with this reverse chimeric locus was the foundation of the Regeneron patents. When mice having the reverse chimeric locus are inoculated, the immune response is much improved compared to mice in which the C segments have been replaced as well, and the mice are not immunologically sick. The antibodies produced by such mice can easily be made suitable for use in humans by later replacement of the mouse constant region with human sequences, which is a technologically simple thing to do.

However, this is where one runs into a problem. The specific replacement of only the mouse V, D and J sequences with the human equivalents is extremely challenging due to the amount of DNA that must be targeted to a specific location in the mouse genome. It was not until over a decade after the original patent was filed that the replacement of all the mouse V, D and J segments with corresponding human segments, whilst retaining the mouse C segments, was actually achieved.

The patents at issue

Claim 1 of the 163 patent is as follows:

1. A transgenic mouse that produces hybrid antibodies containing human variable regions and mouse constant regions, wherein said mouse comprises an in situ replacement of mouse VDJ regions with human VDJ regions at a murine chromosomal immunoglobulin heavy chain locus and an in situ replacement of mouse VJ regions with human VJ regions at a murine chromosomal immunoglobulin light chain locus.

Claims 1, 5 and 6 of the 287 patent are as follows:

1. A method of modifying an endogenous immunoglobulin heavy chain variable region gene locus in an isolated mouse embryonic stem (ES) cell by an in situ replacement of V, D, and J gene segments of the endogenous locus with orthologous human V, D and J gene segments, to create a modified immunoglobulin locus that produces hybrid antibodies containing human variable regions and mouse constant regions, said method comprising:

a) obtaining a large cloned genomic fragment greater than 20kb containing orthologous human V, D, and J gene segments; b) using bacterial homologous recombination to genetically modify the cloned genomic fragment of (a) to create a large targeting vector for use in a mouse ES cell (LTVEC); c) introducing the LTVEC of (b) into a mouse ES cell to replace said V, D, and J segments in situ with the orthologous human V, D and J gene segments; and d) using a quantitative assay to detect modification of allele (MOA) in the mouse ES cell of (c) to identify a mouse ES cell in which said V, D and J segments have been replaced in situ with the orthologous human V, D and J gene segments.

5. A genetically modified eukaryotic cell or a mouse comprising a genetically modified immunoglobulin heavy chain variable region locus obtainable by the method of any one of the preceding claims in situ in place of the endogenous immunoglobulin heavy chain variable region gene locus. 6. A mouse embryonic stem (ES) cell containing a genetically modified immunoglobulin heavy chain variable region gene locus obtainable by the method of any one of claims 1 to 4 in situ in place of the endogenous immunoglobulin heavy chain variable region gene locus.

Much was made of the construction of these claims during the High Court and Court of Appeal trials. Notably, the claims are silent on the extent of the in situ replacement of the V, D and J segments. In the end, it was determined the claims encompassed mice in which at least a portion of each of the mouse V, D and J segments had been positionally replaced with at least a portion of each of the human V, D and J segments. It was also determined the claim scope extended to mice in which all of the mice V, D and J segments had been replaced with human segments. The lower end of this range was technologically feasible at the priority date and, moreover, the resulting mice did not suffer from immunological sickness. However, the range of antibodies than can be produced in such mice is limited (and it required the skilled person to use a method different to the one described in the patent, a matter that was considered extensively in the earlier judgments but is not of relevance here).

However, most of the range of the claim, up to and including the significantly more ambitious aim of providing mice with entirely replaced V, J and D segments was not possible without a person coming up with several inventive developments of their own. Yet the scope of the claims clearly extended to these technologically advantageous mice. Moreover, the Kymab mice did have replacement of all the V, J and D segments whilst retaining the mice C segments, and hence the scope of the claim needed to extend to this extreme if there was to be infringement.

This is the big question: is the scope of the claims justified on the basis of the disclosure of the general principle of a reverse chimeric locus? Or does the claim lack sufficiency because the disclosure enables only the provision of mice with a small portion of their genome replaced?

The relevant legal principles

The main point of contention between the parties was whether the idea to provide a mouse in which at least some of the V, J and D segments are replaced, but the C segments are retained (i.e. the idea of the reverse chimeric locus itself) represented a principle of general application that was applicable to all products falling with the scope of the claims. Kymab conceded the reverse chimeric locus was an inventive advance. Moreover, all mice falling within the scope of the claims would have the advantage of not being immunologically sick.

However, to Regenerons detriment, the UKSC found the legal concept of a principle of general application to be limited in scope.

It is well established that for a patent monopoly to be considered sufficiently disclosed, it must be possible for the skilled person to make substantially all the types or embodiments of products falling within the scope of the claim (T226/85, Unilever/Stable Bleaches). Regeneron attempted to rely on T292/85, a seminal decision of the Board of Appeal of the EPO, which stated an invention is sufficiently disclosed if at least one way is clearly indicated enabling the skilled person to carry out the invention. However, in the UKSCs view, and referring to T435/91 on this point, taken in context one had to bear in mind at least one way was enough as long as there are suitable variants known to the skilled person through the disclosure or common general knowledge which provide the same effect for the invention (emphasis added). It is those variants that enable the rest of the scope of the claim.

In Regenerons case, it was not possible to rely on either the content of the disclosure or the common general knowledge to enable the remaining scope, because of the technical difficulties associated with the specific and targeted replacement of larger parts of the mouse genome.

Rather, the general principle, if it is to be relied upon, must itself allow the scope of the claim to be practiced by the skilled person. The Regeneron patents failed to meet this test, because the contribution of the general principle of a reverse chimeric locus did not itself enable the scope of claims. Quoting Chiron Corpn v Organon Teknika Ltd (No 3) [1994] FSR 202, the UKSC judgment notes at paragraph 51;

This shows that there is more than one way in which the breadth of a claim may exceed the technical contribution to the art embodied in the invention. The patent may claim results which it does not enable, such as making a wide class of products when it enables only one of those products and discloses no principle which would enable others to be made. Or it may claim every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which make no use of the invention. (emphasis present in UKSC judgment)

Furthermore, it is also well established the patent monopoly conferred by the patent must correspond to the extent of the contribution to the art (the patent bargain). In the case of a product claim, the contribution is the ability of the skilled person to make the product itself. Whilst patent applicants are free to choose how widely they frame their claims when filing an application, they risk an attack of a lack of sufficiency (and also lack of inventive step) if that framing is too broad.

In this case, it is clear the UKSC considered the breadth of the claims to be wider than justified by the contribution to the art, because only a small area of the invention could actually be put into practice at the priority date. It is important to note here the UKSC made specific reference to the context of the invention, namely the provision of mice that can produce a diverse range of potentially useful antibodies for human therapy. Mice having only a small amount of the V, J and D segments replaced with their human counterparts are limited in the diversity of antibodies they can produce. Mice having all of the V, D and J segments replaced, on the other hand, are significantly more useful. This range of segment replacement is what the UKSC referred to as a relevant range. Where one falls on that range significantly affects the value or utility of the product in achieving the purpose for which it is to be made (paragraph 56 of the UKSC judgment). The ability (or not) of the skilled person to provide products falling within that relevant range is therefore pertinent to sufficiency.

In this regard, the UKSC referred to T409/91 (Exxon/Fuel Oils), cited in the UK by Generics v Lundbeck among others. In that case, the claim referred to fuel oils containing wax crystals having an average particle size of less than 4,000 nm. Smaller wax crystals were advantageous, because they did not clog filters. However, it was not technically possible to produce wax crystals having a size of less than 1,000 nm, and therefore the range of less than 4,000 nm without a lower limit was insufficient.

The same considerations were applied by the UKSC in this case:

The extent to which that variable region of the human antibody gene structure could be included in the hybrid antibody gene structure was, at that date, understood to be a very important factor affecting the diversity of useful antibodies capable of being discovered by the use of transgenic mice, so that the range thus denominated was a relevant range for sufficiency purposes, even though it did not affect the immunological health of the transgenic mouse. Thus the claim to a monopoly over the whole of that range went far beyond the contribution which the product made to the art at the priority date, precisely because mice at the more valuable end of the range could not be made, using the disclosure in the patents. (paragraph 57 of the UKSC judgment)

On that basis, the UKSC overturned the finding of the Court of Appeal and allowed Kymabs appeal, revoking both patents.

The wider impact of this judgment

For Kymab, this is clearly a significant win, avoiding damages potentially in excess of 60 million, as well as the delivery up of infringing mice. But there are also wider implications of this judgment from the UKSC.

The UKSC made a clear distinction in this case between the inception of an idea (the concept of the reverse chimeric locus) and the reduction of that idea to practice. The completion of both of these are required to arrive at a patentable invention. Regeneron met the first stage of this test, but only met the second part of this test for a small area of the eventual claim scope. Without the further contribution to the art of how to reduce the idea to practice across the remainder of the claim scope, sufficiency for the claim as a whole was denied.

This serves as an important reminder: one must include optional language in patent drafts that puts limits on the scope of each feature, where the range of that feature directly influences the value or utility of the invention by virtue of it being responsible for the advantages of the invention. It may also be sensible to include these limitations in dependent claims, to allow them to more easily be relied upon during post-grant proceedings, in particular national proceedings where the ability to amend claims may be more limited than in post-grant proceedings before the EPO. One can easily see why Regeneron would not have wanted such a limitation be introduced into their own claim since, although it would have been less vulnerable to a sufficiency attack, it would not have encompassed Kymabs mice and there would have been no infringement. That being said, Regeneron still has several pending divisional applications in the same family, so it is possible further proceedings could eventually be forthcoming.

To this author it seems possible Regeneron could have fared better had the contribution to the art been considered by the Court as the provision of mice that do not suffer from immunological sickness, rather than the downstream and more ambitious goal of providing a diverse library of antibodies for human therapy. The fact the actual utility of the mice was framed in this latter way meant the invention was only achieved in part. The reduction of immunological sickness, however, was achieved for the entire scope of the claim. Indeed, this appears to be the basis for the sole dissent in this judgment (by Lady Black). Perhaps this judgment may therefore also serve as a word of caution against promising too much in patent specifications. If a defence to a sufficiency attack relies (at least in part) upon the framing of the contribution of the invention in a particular way, it would probably be more convincing if said contribution corresponds with what the patent itself says.

An additional consideration, one that is already on the mind of patent applicants, is the decision of when to file an application. If claim breadth is important, should you wait to file the application when you have more examples or have further refined the technique? That will not always be an option, such as in this case when it was many more years before the entire scope of the claim was enabled. At the very least, have detailed conversations with your inventors about each feature of the claims, and determine where the scope is justified (does the common general knowledge enable the remaining scope), or where more evidence or explanation might be needed on filing to support that scope. At the very least, optional limiting language should be included, should you need to narrow that feature in future.

Finally, it is curious the UKSC judgment is in direct contradiction to the Board of Appeals finding in proceedings relating to one of the two Regeneron patents (EP1360287 in T2220/14) and, curiouser still, the UKSC judgment makes no reference to this contradiction, other than to state at paragraph 30 the interpretative objective is to strive for consistency between European and UK patent law. Yet the jurisprudence of the Boards of Appeal at the EPO clearly influenced the final conclusion of the Court. Clearly one cannot rely on the outcome of proceedings before the EPO to predict the outcome of national proceedings, and this judgment is another example of that. Perhaps this UKSC judgment will, nevertheless, influence the awaited Board of Appeal decision in connection with the other Regeneron patent (EP2264163), which was upheld at first instance by the Opposition Division but for which there is a pending appeal (T1043/18).

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Regeneron v Kymab and the effect of claim scope on the requirement of sufficiency of disclosure - Lexology

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Coronavirus Responses Highlight How Humans Have Evolved to Dismiss Facts That Don’t Fit Their Worldview – Scientific American

§ June 27th, 2020 § Filed under Genetically Modified Humans Comments Off on Coronavirus Responses Highlight How Humans Have Evolved to Dismiss Facts That Don’t Fit Their Worldview – Scientific American

Bemoaning uneven individual and state compliance with public health recommendations, top U.S. COVID-19 adviser Anthony Faucirecently blamedthe countrys ineffective pandemic response on an American anti-science bias. He called this bias inconceivable, because science is truth. Fauci compared those discounting the importance of masks and social distancing to anti-vaxxers in their amazing refusal to listen to science.

It is Faucis profession of amazement that amazes me. As well-versed as he is in the science of the coronavirus, hes overlooking thewell-established scienceof anti-science bias, or science denial.

Americans increasingly exist in highly polarized, informationally insulated ideological communities occupying their owninformation universes.

Within segments of the political blogosphere,global warmingis dismissed as either a hoax or so uncertain as to be unworthy of response. Within other geographic or online communities, the science ofvaccine safety,fluoridated drinking waterandgenetically modified foodsis distorted or ignored. There is amarked gap in expressed concernover the coronavirus depending on political party affiliation, apparently based in part on partisan disagreements over factual issues like theeffectiveness of social distancingorthe actual COVID-19 death rate.

In theory, resolving factual disputes should be relatively easy: Just present strong evidence, or evidence of a strong expert consensus. This approach succeeds most of the time, when the issue is, say, the atomic weight of hydrogen.

But things dont work that way when scientific advice presents a picture that threatens someones perceived interests or ideological worldview. In practice, it turns out that ones political, religious or ethnic identity quite effectively predicts ones willingness to accept expertise on any given politicized issue.

Motivated reasoning is what social scientists call the process of deciding what evidence to accept based on the conclusion one prefers. As I explain in my book, The Truth About Denial, this very human tendency applies to all kinds of facts about the physical world, economic history and current events.

The interdisciplinary study of this phenomenon has made one thing clear: The failure of various groups to acknowledge the truth about, say, climate change, isnot explained by a lack of informationabout the scientific consensus on the subject.

Instead, what strongly predicts denial of expertise on many controversial topics is simply ones political persuasion.

A2015 metastudyshowed that ideological polarization over the reality of climate change actually increases with respondents knowledge of politics, science and/or energy policy. The chances that a conservative is a climate science denier issignificantly higherif he or she is college educated. Conservatives scoring highest on tests forcognitive sophisticationorquantitative reasoning skillsare most susceptible to motivated reasoning about climate science.

Denialism is not just a problem for conservatives. Studies have foundliberals are less likely to accepta hypothetical expert consensus on the possibility of safe storage of nuclear waste, or on the effects of concealed-carry gun laws.

The human talent for rationalization is a product of many hundreds of thousands of years of adaptation. Our ancestors evolved in small groups, wherecooperation and persuasionhad at least as much to do with reproductive success as holding accurate factual beliefs about the world. Assimilation into ones tribe required assimilation into the groups ideological belief system regardless of whether it was grounded in science or superstition. An instinctive bias in favor of ones in-group and its worldview is deeply ingrained in human psychology.

A human beings very sense of selfis intimately tied up withhis or her identity groups status and beliefs. Unsurprisingly, then, people respond automatically and defensively to information that threatens the worldview of groups with which they identify. We respond with rationalization and selective assessment of evidence that is, we engage in confirmation bias, giving credit to expert testimony we like while finding reasons to reject the rest.

Unwelcome information can also threaten in other ways. System justification theorists like psychologistJohn Josthave shown how situations that represent a perceived threat to established systems trigger inflexible thinking. For example, populations experiencing economic distress or an external threat have often turned toauthoritarian leaderswhopromise security and stability.

In ideologically charged situations, ones prejudices end up affecting ones factual beliefs. Insofar as you define yourself in terms of yourcultural affiliations, your attachment to the social or economic status quo, or a combination, information that threatens your belief system say, about the negative effects of industrial production on the environment can threaten your sense of identity itself. If trusted political leaders or partisan media are telling you that the COVID-19 crisis is overblown, factual information about a scientific consensus to the contrary can feel like a personal attack.

This kind of affect-laden, motivated thinking explains a wide range of examples of an extreme, evidence-resistant rejection of historical fact and scientific consensus.

Have tax cuts been shown to pay for themselves in terms of economic growth? Do communities with high numbers of immigrants have higher rates of violent crime? Did Russia interfere in the 2016 U.S. presidential election? Predictably, expert opinion regarding such matters is treated by partisan media as though evidence is itselfinherently partisan.

Denialist phenomena are many and varied, but the story behind them is, ultimately, quite simple. Human cognition is inseparable from the unconscious emotional responses that go with it. Under the right conditions, universal human traits like in-group favoritism, existential anxiety and a desire for stability and control combine into a toxic, system-justifying identity politics.

Science denial is notoriously resistant to facts because it isnt about facts in the first place. Science denial is an expression of identity usually in the face of perceived threats to the social and economic status quo and it typically manifests in response to elite messaging.

Id be very surprised if Anthony Fauci is, in fact, actually unaware of the significant impact of politics on COVID-19 attitudes, or of what signals are being sent byRepublican state government officials statements,partisan mask refusal in Congress, or the recentTrump rally in Tulsa. Effective science communication is critically important because of the profound effects partisan messaging can have on public attitudes. Vaccination, resource depletion, climate and COVID-19 are life-and-death matters. To successfully tackle them, we must not ignore what the science tells us about science denial.

Read more about the coronavirus outbreakfromScientific Americanhere. And read coverage from ourinternational network of magazines here.

This article was originally published on The Conversation. Read the original article.

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Coronavirus Responses Highlight How Humans Have Evolved to Dismiss Facts That Don't Fit Their Worldview - Scientific American

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Coronavirus responses highlight how humans are hardwired to dismiss facts that don’t fit their worldview – The Conversation US

§ June 25th, 2020 § Filed under Genetically Modified Humans Comments Off on Coronavirus responses highlight how humans are hardwired to dismiss facts that don’t fit their worldview – The Conversation US

Bemoaning uneven individual and state compliance with public health recommendations, top U.S. COVID-19 adviser Anthony Fauci recently blamed the countrys ineffective pandemic response on an American anti-science bias. He called this bias inconceivable, because science is truth. Fauci compared those discounting the importance of masks and social distancing to anti-vaxxers in their amazing refusal to listen to science.

It is Faucis profession of amazement that amazes me. As well-versed as he is in the science of the coronavirus, hes overlooking the well-established science of anti-science bias, or science denial.

Americans increasingly exist in highly polarized, informationally insulated ideological communities occupying their own information universes.

Within segments of the political blogosphere, global warming is dismissed as either a hoax or so uncertain as to be unworthy of response. Within other geographic or online communities, the science of vaccine safety, fluoridated drinking water and genetically modified foods is distorted or ignored. There is a marked gap in expressed concern over the coronavirus depending on political party affiliation, apparently based in part on partisan disagreements over factual issues like the effectiveness of social distancing or the actual COVID-19 death rate.

In theory, resolving factual disputes should be relatively easy: Just present strong evidence, or evidence of a strong expert consensus. This approach succeeds most of the time, when the issue is, say, the atomic weight of hydrogen.

But things dont work that way when scientific advice presents a picture that threatens someones perceived interests or ideological worldview. In practice, it turns out that ones political, religious or ethnic identity quite effectively predicts ones willingness to accept expertise on any given politicized issue.

Motivated reasoning is what social scientists call the process of deciding what evidence to accept based on the conclusion one prefers. As I explain in my book, The Truth About Denial, this very human tendency applies to all kinds of facts about the physical world, economic history and current events.

The interdisciplinary study of this phenomenon has made one thing clear: The failure of various groups to acknowledge the truth about, say, climate change, is not explained by a lack of information about the scientific consensus on the subject.

Instead, what strongly predicts denial of expertise on many controversial topics is simply ones political persuasion.

A 2015 metastudy showed that ideological polarization over the reality of climate change actually increases with respondents knowledge of politics, science and/or energy policy. The chances that a conservative is a climate science denier is significantly higher if he or she is college educated. Conservatives scoring highest on tests for cognitive sophistication or quantitative reasoning skills are most susceptible to motivated reasoning about climate science.

Denialism is not just a problem for conservatives. Studies have found liberals are less likely to accept a hypothetical expert consensus on the possibility of safe storage of nuclear waste, or on the effects of concealed-carry gun laws.

The human talent for rationalization is a product of many hundreds of thousands of years of adaptation. Our ancestors evolved in small groups, where cooperation and persuasion had at least as much to do with reproductive success as holding accurate factual beliefs about the world. Assimilation into ones tribe required assimilation into the groups ideological belief system regardless of whether it was grounded in science or superstition. An instinctive bias in favor of ones in-group and its worldview is deeply ingrained in human psychology.

A human beings very sense of self is intimately tied up with his or her identity groups status and beliefs. Unsurprisingly, then, people respond automatically and defensively to information that threatens the worldview of groups with which they identify. We respond with rationalization and selective assessment of evidence that is, we engage in confirmation bias, giving credit to expert testimony we like while finding reasons to reject the rest.

Unwelcome information can also threaten in other ways. System justification theorists like psychologist John Jost have shown how situations that represent a perceived threat to established systems trigger inflexible thinking. For example, populations experiencing economic distress or an external threat have often turned to authoritarian leaders who promise security and stability.

In ideologically charged situations, ones prejudices end up affecting ones factual beliefs. Insofar as you define yourself in terms of your cultural affiliations, your attachment to the social or economic status quo, or a combination, information that threatens your belief system say, about the negative effects of industrial production on the environment can threaten your sense of identity itself. If trusted political leaders or partisan media are telling you that the COVID-19 crisis is overblown, factual information about a scientific consensus to the contrary can feel like a personal attack.

This kind of affect-laden, motivated thinking explains a wide range of examples of an extreme, evidence-resistant rejection of historical fact and scientific consensus.

Have tax cuts been shown to pay for themselves in terms of economic growth? Do communities with high numbers of immigrants have higher rates of violent crime? Did Russia interfere in the 2016 U.S. presidential election? Predictably, expert opinion regarding such matters is treated by partisan media as though evidence is itself inherently partisan.

Denialist phenomena are many and varied, but the story behind them is, ultimately, quite simple. Human cognition is inseparable from the unconscious emotional responses that go with it. Under the right conditions, universal human traits like in-group favoritism, existential anxiety and a desire for stability and control combine into a toxic, system-justifying identity politics.

Science denial is notoriously resistant to facts because it isnt about facts in the first place. Science denial is an expression of identity usually in the face of perceived threats to the social and economic status quo and it typically manifests in response to elite messaging.

Id be very surprised if Anthony Fauci is, in fact, actually unaware of the significant impact of politics on COVID-19 attitudes, or of what signals are being sent by Republican state government officials statements, partisan mask refusal in Congress, or the recent Trump rally in Tulsa. Effective science communication is critically important because of the profound effects partisan messaging can have on public attitudes. Vaccination, resource depletion, climate and COVID-19 are life-and-death matters. To successfully tackle them, we must not ignore what the science tells us about science denial.

This is an updated version of an article originally published on Jan. 31, 2020.

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Marking Environmental Progress Earth Day’s 50th Anniversary Part III – Mackinac Center for Public Policy

§ June 25th, 2020 § Filed under Genetically Modified Humans Comments Off on Marking Environmental Progress Earth Day’s 50th Anniversary Part III – Mackinac Center for Public Policy

With this post, well be halfway through our list of 50 reasons why people can be optimistic about the future of the human race and our environment. Our relative wealth and health, our ability to use new and more efficient and effective technologies, and our access to markets are supplying us with abundance that has never been seen before in human history.

Of course, that doesnt mean we dont still suffer from difficulties, and 2020 is the perfect example of a year that brings many of those difficulties directly into our lives. But, despite the problems we are facing, we are still relatively well-fed and well-clothed on the whole. We still have access to a near endless variety of entertainment, and we have the most-trained medical experts that the world has ever known actively working to address todays medical challenges.

Even though we face many challenges, we are still some of the most fortunate humans to have ever existed. Lets continue with our list of 50 reasons we can be optimistic about the future of humanity. For a quick review, here are the first 15 weve already introduced:

The next 10 are:

Weve covered a lot of ground so far, but were still only halfway through our list of 50! Be sure to check out the first two 50th Anniversary of Earth Day posts here and here. Then check back soon for points 26 through 35.

Permission to reprint this blog post in whole or in part is hereby granted, provided that the author (or authors) and the Mackinac Center for Public Policy are properly cited. Permission to reprint any comments below is granted only for those comments written by Mackinac Center policy staff.

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Could a barn full of dairy cattle help in the fight against coronavirus? – Grand Island Independent

§ June 25th, 2020 § Filed under Genetically Modified Humans Comments Off on Could a barn full of dairy cattle help in the fight against coronavirus? – Grand Island Independent

Thousands of people around the world hospitalized with COVID-19 have been treated with whats known as convalescent plasma donated by people whove recovered from the infection.

Doctors hope to harness from that plasma the antibodies that donors have produced in response to the disease. The plasma is given to patients with the goal of helping them fight off the infection or preventing infection in the first place.

But a Sioux Falls, South Dakota, biotech firm thinks it has a better alternative to convalescent plasma: A barn full of dairy cattle that are producing human antibodies to COVID-19.

The company, SAb Biotherapeutics, plans to begin testing the antibodies in human trials yet this summer.

The cattle, a Holstein mix, look just like those found on many Midwestern farms. But theyre not your basic bovine. Theyve been genetically modified to have a partially human immune system.

The company then injects them with a noninfectious portion of the novel coronavirus so they produce antibodies to fight it. We have already shown our antibodies neutralize the SARS-CoV-2 virus (the more technical name for the novel coronavirus that causes COVID-19), and we have already produced a clinical material to be used for our clinical trials, said Eddie Sullivan, the companys president and CEO.

And, because they inject the cows over and over again, the animals build up high levels of those neutralizing antibodies, more than whats found in convalescent plasma, he said.

A herd of genetically modified cattle in Sioux Falls, South Dakota, is making human antibodies that can neutralize the novel coronavirus. SAb Biotherapeutics plans to begin trials in humans this summer.

The company announced recently in a press release that the cow-made antibodies were four times better at blocking the virus from entering cells than the most potent convalescent plasma they studied.

William Klimstra, a viral immunologist at the University of Pittsburgh, tested the cow-made antibodies against convalescent plasma in cell cultures.

In the cell culture models, we showed there was more neutralizing capacity in cow serum and antibody preparations than in convalescent serum, said Klimstra, who has worked with SAb since 2012.

The research was shared by the company but has not been published in a scientific journal.

The cattle, Sullivan said, have a couple of other advantages over human donors. For one, cows are big animals and can produce a lot of plasma, donating 30 to 45 liters a month versus the 2 to 3 liters a human donor could supply.

The cattle also have a more robust immune response than humans, in order to keep their ruminant guts from being overrun by pathogens. The repeated injections bump up that response. And the cattle live in a controlled environment, unlike human plasma donors who come from different locations and may be exposed to all sorts of things.

The companys technology, Sullivan said, also produces a polyclonal response, meaning the antibodies can bind to more than one site on the virus. Monoclonal antibodies, as the name suggests, can bind to only one.

Sullivan said the polyclonal response is important because the virus could mutate. If a virus mutates on that place where a monoclonal antibody (binds), that monoclonal (antibody) is no longer functional, he said.

It would be difficult, however, for a virus to mutate in so many places that polyclonal antibodies, actually a collection of molecules, would become ineffective, he said.

The natural way our bodies fight disease is a polyclonal response, said Sullivan, who has degrees in molecular biology and reproductive physiology.

Meantime, several monoclonal antibodies to the coronavirus also are expected to enter clinical trials this summer. According to a recent commentary in the Journal of the American Medical Association, those antibodies have been chosen to target a part of the virus that has held steady. Some products will include a combination of two monoclonal antibodies targeting different sites.

In addition, another company, Regeneron Pharmaceuticals, announced that it had started human trials with a drug derived from mice, CNN reported.

Such antibodies generally are viewed both as a potential treatment and a possible preventative, in lieu of a vaccine, to keep people from getting sick.

The technology behind SAb Biotherapeutics approach dates back nearly two decades. Since 2014, the company has produced antibodies to a number of infectious diseases, including Ebola, Zika and the original SARS, using cattle.

The company had completed a clinical trial in humans with antibodies against Middle East respiratory syndrome, which is caused by a coronavirus related to the novel coronavirus, and was proceeding toward a second phase of trials when the pandemic struck.

Those experiences gave the company a head start. The cows were producing antibodies to the novel coronavirus within seven weeks. The company has initial funding of $9.4 million through an existing federal contract to take the project through preclinical trials.

The company has been working with the Food and Drug Administration through the testing process and would eventually have to get approval from the agency, as would the makers of any new drug, before the product could be used on a wider scale in humans.

Sullivan said its rewarding to get to a point where the technology, which took years to develop, is being put to use and can perhaps have a significant impact on one of the most serious health threats in a lifetime.

This is why SAb and our employees have worked so hard over the last few months, he said. I have an amazing, dedicated team of scientists and individuals who have been just absolutely focused on being able to move this forward.

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Being happy can protect you from gastrointestinal distress – The New Indian Express

§ June 20th, 2020 § Filed under Genetically Modified Humans Comments Off on Being happy can protect you from gastrointestinal distress – The New Indian Express

By IANS

NEW YORK: Researchers have found that Serotonin, a chemical known for encouraging happiness and well-being, can reduce the ability of some intestinal pathogens to cause deadly infections.

The findings, publishing in the journal Cell Host & Microbe, could offer a new way to fight infections for which few truly effective treatments currently exist.

"Although the vast majority of research on serotonin has centred on its effects in the brain, about 90 per cent of this neurotransmitter - a chemical that nerve cells use to communicate with each other - is produced in the gastrointestinal tract, study lead author Vanessa Sperandio from UT Southwestern Medical Centre in the US, explained.

In humans, trillions of bacteria live within this space. Most of these gut bacteria are beneficial, but pathogenic bacteria can also colonize the gastrointestinal tract, causing serious and potentially fatal infections.

Because gut bacteria are significantly affected by their environment, the research team wondered whether the serotonin produced in the gut can affect the virulence of pathogenic bacteria that infect the gastrointestinal tract.

They worked with Escherichia coli O157, a species of bacteria that causes periodic outbreaks of often deadly foodborne infection.

The team grew these pathogenic bacteria in Petri dishes in the lab, then exposed them to serotonin.

Gene expression tests showed that serotonin significantly reduced the expression of a group of genes that these bacteria use to cause infections.

Additional experiments using human cells showed that the bacteria could no longer cause infection-associated lesions on the cells if these bacteria were exposed to serotonin.

Next, the researchers examined how serotonin affected virulence in living hosts.

Using mice, the researchers studied how serotonin might change the ability for Citrobacter rodentium - a mouse gut bacterium often used as an analog for E. coli in humans - to infect and sicken their hosts.

These mice were genetically modified to either over- or underproduce serotonin in their gastrointestinal tracts.

Those that overproduced this neurotransmitter were less likely to become colonised by C. rodentium after being exposed to this bacterium or had relatively minor courses of illness, according to the study

Treating mice with fluoxetine (sold under the brand name Prozac) to increase serotonin levels prevented them from getting sick from C. rodentium exposure.

However, the mice that underproduced serotonin became much sicker after bacterial exposure, often dying from their illness.

In the future, the research team plan to study the feasibility of manipulating serotonin levels as a way of fighting bacterial infections in the gastrointestinal tract.

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Antibody therapies could treatand even preventCovid-19. Here’s what you need to know. – The Daily Briefing

§ June 18th, 2020 § Filed under Genetically Modified Humans Comments Off on Antibody therapies could treatand even preventCovid-19. Here’s what you need to know. – The Daily Briefing

Researchers and drug companies around the world are testing the use of antibody therapies to treat and prevent Covid-19but while some of the therapies have shown promise, experts say the therapies might not be available for use until next year. Here's what you need to know about the potential treatments.

Antibody therapies are created using antibodies that were naturally generated by either a human or animal that was infected with a given disease or virus. For Covid-19 antibody therapies, the treatments rely on isolated antibodies to neutralize the new coronavirus, known as SARS-CoV-2, which causes Covid-19.

Researchers have so far considered convalescent plasma treatments, which are made from the plasma of people who were recently infected with the virus and transfused into Covid-19 patients, as well as other treatments developed from the blood of newly recovered patients as potential antibody treatments for Covid-19.

Researchers have also started developing monoclonal antibodies, which are antibodies that can be isolated and manufactured in larger quantities via artificial reproduction, for the new coronavirus. According to Reuters, these types of antibody therapies can be easier to scale, because unlike convalescent plasma, monoclonal antibodies do not require a "steady supply of antibody-rich blood."

Some scientists are considering using the monoclonal antibodies for a prophylactic treatment that potentially could prevent infection from the new coronavirus before it is contracted, Scientific American reports.

Several organizations are developing these potential therapies.

For instance, Regeneron Pharmaceuticals started developing Covid-19 antibodies in January, when the disease's genetic sequence became available. Researchers culled the antibodies from genetically modified mice that carry human genes, as well as people, to create an "antibody cocktail," Scientific American reports. Christos Kyratsous, VP of research on infectious diseases and viral vector technologies at Regeneron, said the cocktail could enter clinical trials in June, with the goal of having doses of its preventative monoclonal antibody treatments ready for use by later this summer or fall, according to Scientific American.

Separately, Vanderbilt University researchers have collected antibodies from about a dozen people who've recovered from Covid-19 and found about 40 antibodies that have the potential to neutralize the novel coronavirus, according to Robert Carnahan, associate director of the Vanderbilt Vaccine Center. The researchers are working with Cambridge University and AstraZeneca to develop potential therapies, some of which could enter clinical trials this summer, Carnahan said.

AstraZeneca is also working on a potential treatment combining two antibodies, which can "reduce the chance of resistance developing to one antibody," according to Pascal Soriot, the drugmaker's CEO.

Eli Lilly is developing different antibody treatments, including a monoclonal treatment, that have already started early testing in humans.

Meanwhile, the CoVIg-19 Plasma Alliance is using convalescent plasma to develop a standardized dose of antibodies that could be used on patients with different blood types. GlaxoSmithKline and AbbVie are also working to develop potential antibody treatments for Covid-19, according to Reuters.

Studies suggest antibody therapies could be an effective way to treat Covid-19, but health experts say it will be a while before the treatments can be deployed.

Jill Horowitz, executive director of strategic operations at Rockefeller University's Laboratory of Molecular Immunology, said manufacturers may not have the existing capacity to produce antibody therapies. "Every factory that gets built has a reason. And you can bet that all those factories are committed to [existing] drugs that we need," Horowitz said.

Antibodies are also expensive, especially since they often are administered intravenouslya fact that could make them difficult to deliver on a larger scale, especially in lower-income countries, according to Arthur Reingold, an epidemiologist and biostatistician at the University of California-Berkeley.

The type of antibody treatment also determines when the treatments will be available. For instance, clinical trials for therapeutic treatments are usually faster than trials for prophylactic treatments, according to Horowitz. And since "therapy is a dire need right now," FDA is likely to approve treatments for Covid-19 faster than preventives for the diseasealthough approvals for antibody treatments are likely at least six months away, as well, Horowitz said.

So while antibody therapies may eventually help treat Covid-19, health experts "should be careful about how they communicate and basically create hope in the population," according to Florian Krammer, a microbiologist and infectious disease expert at the Icahn School of Medicine at Mount Sinai. "I think it's very dangerous to say, 'Within [months], we will have [an] antibody therapeutic that works, and everybody will get it.' That's unrealistic" (Erman, Reuters, 6/19; Kramer, Scientific American, 5/29; The Guardian, 6/7).

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Regeneron Begins Human Trials of First Dual Antibody Cocktail for Prevention and Treatment of COVID-19 – HospiMedica

§ June 16th, 2020 § Filed under Genetically Modified Humans Comments Off on Regeneron Begins Human Trials of First Dual Antibody Cocktail for Prevention and Treatment of COVID-19 – HospiMedica

Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA) has initiated the first clinical trial of REGN-COV2, its investigational dual antibody cocktail for the prevention and treatment of COVID-19.

Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies and have scaled them up for clinical use with the company's in-house VelociMab and manufacturing capabilities. The two antibodies bind non-competitively to the critical receptor binding domain (RBD) of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment.

The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure (such as healthcare workers or first responders) and uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate).

The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints. Data from the Phase 1 and Phase 2 studies will be used to refine the endpoints and determine size for the Phase 3 studies.

"We have created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral 'escape,' a critical precaution in the midst of an ongoing global pandemic," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. "REGN-COV2 could have a major impact on public health by slowing spread of the virus and providing a needed treatment for those already sick and could be available much sooner than a vaccine. The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines. Ultimately, the world needs multiple solutions for COVID-19, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches."

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Fact Check: Have genetically modified mosquitoes been OKd for release in US? – The Columbus Dispatch

§ June 15th, 2020 § Filed under Genetically Modified Humans Comments Off on Fact Check: Have genetically modified mosquitoes been OKd for release in US? – The Columbus Dispatch

The claim:

A British biotech company called Oxitec has permission to release genetically modified mosquitoes in Florida and Texas.

What we found:

The Environmental Protection Agency approved an experimental use permit May 1 that allows Oxitec to release genetically modified mosquitoes in the Florida Keys and Harris County, Texas, where Houston is located.

"To meet todays public health challenges head-on, the nation needs to facilitate innovation and advance the science around new tools and approaches to better protect the health of all Americans," according to the EPAs press release.

The permit, which lasts for two years, requires Oxitec to "monitor and sample the mosquito population weekly."

"EPA has also maintained the right to cancel the (permit) at any point during the 24-month period if unforeseen outcomes occur," according to the release.

Wait. Why would a company create a mosquito? What purpose does it serve?

Remember a few years ago when people especially pregnant women were concerned about contracting the Zika virus.

Its the virus that could cause a birth defect called microcephaly (underdevelopment of the head and brain), according to the Centers for Disease Control.

Well, diseases like Zika, dengue, chikungunya and yellow fever are all carried by one type of mosquito, the Aedes aegypti. Oxitec claims its Aedes aegypti (known as the OX5034) can drastically lower the wild populations of these specific mosquitoes.

Heres how it works

Male mosquitoes dont bite; they feed on flower nectar while female mosquitoes use blood to grow their eggs. Basically, male mosquitoes are harmless to humans.

Oxitec created a male mosquito with a special gene that prevents their female offspring from surviving to adulthood. The new males grow up, mate with more wild females and over time the number of Aedes Aegypti declines.

"Continual, large-scale releases of these OX5034 GM males should eventually cause the temporary collapse of a wild population," according to Oxitec.

In Brazil, which suffered a Zika outbreak in 2015 and 2016, the company claims its "friendly" mosquitoes reduced the population of Aedes Aegypti by 89 to 96 percent.

Is there opposition to these genetically modified mosquitoes?

Yes.

Introduction into the U.S.

Oxitec has been trying to make Florida the first U.S. test site for its "friendly" mosquitoes for nearly a decade.

The company came close in 2016 when citizens in Monroe County (where the Florida Keys are located) voted for their release. Key Haven residents, however voted against it, and thats where the company planned to release the mosquitoes. County officials planned to pick another community, but the federal government upended those plans.

Regulatory control over the mosquitoes was changed from the Food and Drug Administration to the EPA.

"We had to reapply with the EPA," said Dr. Nathan Rose, head of regulatory affairs at Oxitec.

So, now the company is basically back where it was in 2016. Rose said they are waiting on approvals from the Florida Department of Agriculture and Consumer Services and the Florida Keys Mosquito Control District.

The Florida Keys Environmental Coalition plans to try and stop that from happening.

"We have repeatedly asked for Oxitec to work with us to prove the technology is safe," Barry Wray, executive director of the Florida Keys Environmental Coalition, said in a statement in 2018 after Oxitec applied for its second permit.

"Instead of receiving Oxitec's cooperation to provide this confidence, we have witnessed a pattern of avoidance, misrepresentations, obfuscations and using marketing and political influence to persuade the regulatory and community stakeholders to proceed with what is truly a poorly designed experiment on our public and ecosystems," Wray said.

The Texas releases arent scheduled until 2021.

Our ruling: True

The claim that the federal government has given permission for a company to release genetically modified mosquitoes in Florida and Texas is TRUE. But the permits still need local approval.

USA Today Network fact checks are funded in part by a grant from Facebook.

Sources:

EPA Approves Experimental Use Permit to Test Innovative Biopesticide Tool to Better Protect Public Health

Oxitec Our Technology

Oxitec Brazil

NPR, "Why Zika Is Especially Hard On The Women Of Brazil"

NPR, "Florida Keys Approves Trial Of Genetically Modified Mosquitoes To Fight Zika"

Florida Keys Environmental Coalition, "Petitioning the U.S. Senate: Say No to Genetically Modified Mosquitoes Release in the Florida Keys"

astaver@dispatch.com

@annastaver

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A Farmers Group Has Announced Large-Scale Sowing Of Unapproved GM Crops; Heres All You Need To Know – Swarajya

§ June 15th, 2020 § Filed under Genetically Modified Humans Comments Off on A Farmers Group Has Announced Large-Scale Sowing Of Unapproved GM Crops; Heres All You Need To Know – Swarajya

On 8 June, Shetkari Sanghatana a farmers union founded by the late leader Sharad Joshi announced that in the current kharif season, farmers across Maharashtra would undertake mass sowing of genetically modified (GM) crops that havent been approved by the government.

The farmers will also put up boards on their fields proclaiming that they have used GM seeds. A similar agitation was carried out last year too.

Under the Environmental Protection Act ,1989, the usage of the unapproved GM variant can attract a jail term of 5 years and fine of Rs one lakh.

Why are farmers rooting for GM crops?

Humans have actively altered the genetic make-up of plants for thousands of years through domestication.

However, GM crops are those plants whose DNA has been has been modified using genetic engineering methods for adding or enhancing desired traits like:

For example, DMH-11, a GM mustard variety developed by a team of scientists at the Delhi University increases the yield by 25-30 per cent.

Golden Rice is a genetically modified rice with beta carotene, a precursor of Vitamin A. The variety can decrease the death and diseases caused by Vitamin A deficiency in the poverty-stricken regions.

Transgenic GM crops involve insertion of genes from another species, for example, DMH-11 contains Barnase gene from bacterium Bacillus amyloliquefaciens. Bt Cotton contains genes from bacterium Bacillus thuringiensis that is insecticidal to the larvae of moths and butterflies, beetles, cotton bollworms etc.

Cisgenic GM plants are made using genes of the same species or a closely related one, where conventional plant breeding can occur. For example, a hybrid of a wild variety of cabbage with a domesticated one.

Genetic modification can also involve a simple removal of genes without any addition. For example, removal of genes that repress defenses against powdery mildew to produce a strain of wheat that is resistant to the disease. These are subgenic GM plants.

Farmers root for the GM crops because of the desirable traits. Ht Bt cotton reduces the high cost of weeding as they can use glyphosate against the weeds. Bt brinjal reduces the cost of production by cutting down on the use of pesticides.

Genetically modified plant varieties can also be used to produce drugs, biofuel, and in bioremediation.

If GM varieties are superior, where is the problem?

The opposition to GM crops comes from environmental groups as well as the proponents of traditional agricultural practices.

The argument is that the GM varieties can wipe out the native or naturally occurring varieties. Also, the GM variety can give rise to potentially harmful plant species through "gene escape". For example, a herbicide-resistant rice crop that crossbreeds with a weedy relative gives the weed a competitive advantage. So, there is a threat of ecosystem damage.

The greatest challenge to GM crops comes from the perspective of food safety. While till date no ill-effects of GM foods on human health have been recorded, the common people are somewhat repulsed by the thought eating a plant whose genetic make-up contains something from a bacteria. It seems unnatural to them.

Groups like Greenpeace claim that risks related to GM food have not been adequately examined and that GM crops are not sufficiently tested.

There is also the question of unpredictability regarding how an artificial genetic change in the plant may turn out in the longer run. The insert gene could mutate and destabilise the organism. The modification could accidentally switch on the "Sleeper" genes or active genes could become "silent".

The impact of the modified gene on other organisms is also unknown, for example, the horizontal flow of GM pollen to bees' gut or of novel gene sequences in plants to fungi and soil and rumen bacteria.

For developing countries, the issue of GMOs is further confounded by socio-economic considerations.

Most of the research on GMOs is capital intensive and is being carried out by big multi-national corporations like Monsanto which throw tantrums when they dont get the desired government protection.

In 2016, Monsanto threatened to leave India after a show cause notice by the government for revoking patent on one variant of genetically modified BT Cotton after farmers complained that the crop had shown declining resistance against bollworm.

Monsanto could make such a threat because over 90 per cent of cotton grown in India uses Monsantos technology.

Last year, Pepsico filed cases against the Gujarat farmers for illegally growing its registered potato variety used to make Lay's chips.

The GMOs also come at a cost of farmers' access to the plant material. Farmers may be barred from using plant varieties bred from genetic material that originally came from their own fields by the companies holding patents on specific genetic modification "events".

And over and above these come the secondary issues of an effective, independent and transparent regulatory structure.

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Bt corn studied for benefits beyond pest control – Kokomo Perspective

§ June 15th, 2020 § Filed under Genetically Modified Humans Comments Off on Bt corn studied for benefits beyond pest control – Kokomo Perspective

Bt corn is known for its ability to fight insect pests. But it also could have potential benefits for the safety of human food and animal feed. Michigan State University researchers are investigating the corns potential ability to reduce aflatoxin, which is produced by corn mold that can adversely affect the liver. Bt corn has been genetically modified to produce insecticidal proteins that occur naturally in Bacillus thuringiensis.

We havent really known whether there's an impact of Bt corn in reducing aflatoxin; previous field studies havent come to a strong conclusion, said Felicia Wu, a professor in the departments of food science and human nutrition and agricultural, food and resource economics at Michigan State.

Wu and David Hennessy, a professor in the agricultural, food and resource economics department, will review aflatoxin-related crop-insurance claims filed by corn growers. They will use data from the U.S. Department of Agriculture's Risk Management Agency. Theyll study whether there are fewer aflatoxin-related claims where Bt corn is planted.

If we do find that Bt corn reduces aflatoxin even controlling for climate variables and grower practices then we can say 'there's a benefit of Bt corn that typically doesn't enter policy decision-making,' Wu said.

Aflatoxin is produced by Aspergillus fungi, which typically thrive in warmer climates such as those of sub-Saharan Africa, South America, and parts of Central America and Asia. Aflatoxin isnt as common in the United States, but has a presence in southern states. It hasnt been a major issue in Corn Belt states, except in summers when theres significant drought and unusually high temperatures.

That might not be the case in the future. As climate changes aflatoxin issues and potential health risks might move further north, Hennessy said. There is a known positive correlation between aflatoxin levels and liver disease in both humans and animals. Although the U.S. Food and Drug Administration regulates aflatoxin increased levels in U.S. corn could mean feed sold has aflatoxin levels approaching maximum tolerable limits. Per the USDA the standard maximum tolerable limit of aflatoxin in corn varies based on how its used.

In a previous study Wu found aflatoxin stunts animal growth, which could affect producers who use corn in their animal feed. Corn also is a common ingredient in pet food. Visit pubmed.ncbi.nlm.nih.govand search for "Aflatoxin: A 50-year Odyssey" anders.usda.govand search for "Mycotoxin Hazards and Regulations" for more information.

Alex Tekip is a communications manager in the college of agriculture and natural resources at Michigan State University.

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COVID-19’s Achilles’ Heel, Other News From the Bio-IT Community – Bio-IT World

§ June 12th, 2020 § Filed under Genetically Modified Humans Comments Off on COVID-19’s Achilles’ Heel, Other News From the Bio-IT Community – Bio-IT World

June 12, 2020 |The Bio-IT community is continuing to adapt to their newfound role in the fight against the COVID-19 virus. Recent updates include recent collaborations between organizations and universities, as well as innovative modeling tools. Here, we round up the weeks research and industry news for COVID-19.

Literature Updates

A study coming out ofQueen Mary University(London) andCardiff University(Wales) has demonstrated the effectiveness of theGloBodyplatformto detect anti-drug antibodies in the blood of patients with multiple sclerosis. Researchers say the platform, which uses a light-producing enzyme callednanoluciferase, has also been applied to COVID-19 forpotential use in antibody testing to determine whether someone has previously been infected with the virus. Their study, published inNeurology: Neuroimmunology & Neuroinflammation, focused on the detection of antibodies predicting which MS patients were subsequently likely to fail treatment with Alemtuzumab. But theGloBodyplatform could be appliedtoany therapeutic antibody in any clinical condition as well aspre-clinical animal modelsto save time and effort before moving to clinical trials in humans. In a matter of days, researchers were able to produce enough of the COVID-19GloBodyreagent to potentially test 1.6 million people for COVID-19. If the virus mutates, a new test could be made just as quickly.DOI: 10.1212/NXI.0000000000000767

TheCOVID-19 virus has an Achilles' heelits main protease, which is structurally very similar to the SARS coronavirusmakingit an excellent target for inhibitors or new drugs, according toa mathematician and expert in complex systems at the ARAID Foundation at theUniversity of Zaragoza(Spain).He and his colleaguestransformed those structures into proteinresidue networks, wherebyevery amino acidwasrepresented as a node and the interaction between two amino acidswasrepresented by a link between the two.Researchers then applied a sophisticated mathematical measure allowing them to detect how far away a perturbation within a network can be propagated. It revealedthat the protease of SARS-CoV-2 is1,900% more sensitive to the long-range transmission of perturbations than the protease of SARS-CoV-1.Perturbation of a single amino acid within the protease of SARS-CoV-2 gets transmitted to almost the whole network, including very distant amino acids.The group's approach, described inChaos,could be used for massive screening protocols to identify potent inhibitors of the main protease of the COVID-19 virus and, consequently, development of new drugs to kill it.DOI:10.1063/5.0013029

The mostinnovative modeling toolsincluding 3D supports for cell cultures, microfluidic chambers for the culture of organoids and intravital microscopy in animalswere identifiedas the most suitable for accelerating the discovery and preclinical development of antiviral drugs and vaccines for COVID-19 in an article that published inTheranostics.Researchersin Spainspecifically called outdevices developed over the last decade atthePolytechnic University of Milan:artificial niches for stem cell culture, microfluidic bioreactors for tissue culture, and miniaturized imaging windows for intravital microscopy.Some of these devices are already being used for research on neurodegenerative diseases.The same team has also developeda lymph node model engineered inside a miniaturized bioreactor called MOAB,allowing for the study ofimmunization mechanisms such as those produced by vaccines. The authors say these tools are much more realistic than conventional ones and could even replace much of the preclinical research currently conducted on animals.DOI:10.7150/thno.47406

It was recentlyannouncedthat scientists fromStanford Universityare collaborating with researchers at theMolecular Foundry(a nanoscience user facility located at the Department of Energy's Berkeley Lab) todevelop a gene-targeting, antiviral agent against COVID-19.Theyll be applying the Stanford-developedPAC-MAN"techniqueoriginally developed to fight influenzathat usesthegene-editing tool CRISPRas well asalipitoiddelivery systemdeveloped at the Molecular Foundry.The two groups have been working on a system that delivers PAC-MAN into the cells of a patient since late March.PAC-MAN is composed of the virus-killing enzyme Cas13 and a strand of guide RNA that commands it to destroy specific nucleotide sequences in the coronavirus's genome. By scrambling the virus's genetic code, PAC-MAN could neutralize the coronavirus and stop it from replicating inside cells.In late April,researchersovercame one of the key challengesaftertestinga type oflipitoidthatself-assembleswith DNA and RNA into PAC-MAN carriers in a sample of human epithelial lung cells.When packaged with coronavirus-targeting PAC-MAN, the system reduced the amount of synthetic SARS-CoV-2 in solution by more than 90%.The PAC-MAN strategy is described in an article inCell.DOI:10.1016/j.cell.2020.04.020

Cancer researchers atChildren's Hospital of Philadelphiahaveadaptedcomputationaltoolsfor the development of cancer immunotherapiesto identifythe rightregions of the SARS-CoV-2 virus to target with a vaccine,a strategytheydescribe inCell Reports Medicine. They believe aresulting vaccine would provide protection across the human population and drive a long-term immune response.The teamlookedfor regions that would stimulate a memory T-cell response which, when paired with the right B cells, would drive memory B cell formation and provide lasting immunity and do so across most human genomes. They made sure thetargeted regionswerepresent across multiple related coronaviruses, as well as new mutations that increase infectivity,and wereas dissimilar as possible from sequences naturally occurring in humans to maximize safety.The result was a proposed list of 65 peptide sequences, a dozen or so of whichare now being tested invarious combinations in mouse models to assess their safety and effectiveness.DOI: 10.1016/j.xcrm.2020.100036

A group of researcherswith theFDAs Center for Biologics Evaluation and Researchhas determinedhow different proteins associated with SARS-CoV-2 generate immune responseswhen given to rabbits as immunizations. The results, published inScience Translational Medicine, offera better understanding of the quantitative and qualitative aspects of immune response generated by different vaccine antigens,which could benefit the development and evaluation oftherapeutics and vaccinefor COVID-19.Rabbits were immunized with one of four SARS-CoV-2 spike protein antigens like those being used in clinical trials, and the authors observed that antibodies from animals immunized with the receptor-binding domain(RBD),the S1 domain, or the S1+S2 ectodomain neutralized as many as 98% of SARS-CoV-2 virions after two vaccinations. Importantly, the RBD immunization was the most effective option, as it generated more high-affinity antibodies. The researchers did not directly test their vaccine's protective capabilities in the rabbits but say that the ability to elicit high-affinity antibodies may enhance the protective properties of vaccines for COVID-19.DOI: 10.1126/scitranslmed.abc3539

Virologists in the Institute for Biomedical Sciences atGeorgia State Universityhave identified detailed methods onhow to perform research on SARS-CoV-2, includingprocedures that effectively inactivate the virusto enable safe study of infected cells.The peer-reviewed paper, published inViruses, is a resource for newcomers in the field.Because the new pathogen causes serious disease for which there are no definitive treatments, biosafety level 3(BSL3)facilities are required. At Georgia State, biosafety expertsthatoversee the high-containment core created a plan that identified the optimal BSL3 facility on the university's Atlanta Campus for the work, developed rigorous training for researchersalready experienced with high-containment work,and implemented procedures to enable safe and efficient work on SARS-CoV-2.DOI: 10.3390/v12060622

University of Michiganresearchers have found that a long-ignored white blood cell may be central to the immune system overreactionthat is the most common cause of death for COVID-19 patientsand that the rod-shaped particlescan be taken out of circulation.Neutrophils lead the charge inacute respiratory distress syndrome,a complication seen in severe cases of COVID-19, and its their lack of lack of specialization that sometimes makes them not know when to quit.The researchers previously showedthat plastic microparticles injected into the blood of mice could distract neutrophils, diverting them away from areas of severe inflammation in their lungs.Thyealso discovered that neutrophils, unlike other phagocytes,prefereating rod-shaped particles. Thisopensthe possibilityof asphere-based therapywhere otherwhite blood cellsare left todo their job.The team is currently exploring whether neutrophil-distracting particles can be made from medications rather than plastic, and the new delivery system is moving toward clinical trials. U-M has also applied for patent protection and launched a start-up company,Asalyxa.The study published inScience Advances.DOI: 10.1126/sciadv.aba1474

Researchers atWashington UniversitySchool of Medicine (St. Louis) report inCelljournal pre-proofthat they have developed amouse model of COVID-19 that replicates the illness in peopleandsaythe same approach could be adopted easily by other scientists todramatically accelerate the testing of experimental COVID-19 treatments and preventives. Additionally, the modelcould be usedwith mice bred to develop health conditions such as obesity, diabetes or chronic lung disease to investigate why some people develop life-threatening cases of COVID-19 while others recover on their own.The emergence of COVID-19 earlier this year triggered a frantic rush to begin breeding geneticallymodifiedmice with the human ACE2 protein, butthere are still notnearly enough mice for all the researchers who want to study the disease andtest potential vaccines and therapeutics.DOI:10.1016/j.cell.2020.06.011

Comparing the frequencies of human leukocyte antigen (HLA) variants in different human populations,an international team ofresearchershas determined thatwe're not all equal in the face ofCOVID-19.Their study provides anessential reference inventory for identifying the genetic resistance or susceptibility of individuals to the virus.One surprising findingwas that indigenous populations in America had both the highest frequencies of HLA variants that bind the most strongly to peptidesof SARS-CoV-2and the lowest frequencies of those that bind the least strongly.But, as the authors point out, HLA molecules are only one element of immune response thatispredictive ofeffective or ineffective resistance to a virusverified by the fact thatAmerica's Indigenous populations are apparently no less affected than others by COVID-19. The same study showedthat manyHLA variants(generalists)are capable of binding strongly to the peptides of six other viruses with pandemic potential (two other coronaviruses, three influenza viruses and the HIV-1 virus of AIDS). Others do the same for all respiratory-type viruses (coronavirus and influenza). Findings were peer-reviewed andpublished inHLA.DOI: 10.1111/tan.13956

Using an immunoinformatic-based computational approach,researchers fromBar-IlanUniversity(Israel) identifieda set of potential immunodominant epitopes from the SARS-CoV-2 proteome.The epitopes can generate both antibody- and cell-mediated immune responses.The team pinpointed 15 immunogenic regions from three proteins of SARS-CoV-2 and mapped 25 immunodominant epitopes on other SARS-CoV-2 proteins.Seven epitopes, verified as being non-allergenic and non-toxic,were deemed to bepresent in more than 87% of the worldwide virus-affected populationmaking thempotentially effective vaccine candidates.Complete lists of major histocompatibility complex (MHC) proteins that recognize each epitope have been generated and are presented in both the submitted manuscript and a provisional U.S. patent application.The study published inVaccines.DOI: 10.3390/vaccines8020290

Updates from Industry

Adaptive Biotechnologieshas launchedImmuneCODEwithMicrosoftto begin sharing one of the largest, most detailed views of the immune response to COVID-19 in real time based on de-identified data generated from thousands of COVID-19 blood samples from patients around the globe. The open database contains detailed information on the extraordinarily diverse set of T cells shown to specifically recognize unique features of the COVID-19 virus, called antigens, with unprecedented speed and scale. T cells contain a treasure trove of information that could provide one consistent and trackable measure of the immune response. This could help diagnose and manage COVID-19 from exposure through clearance of the virus, and potentially offer an accurate assessment of immunity. Data fromImmuneCODEwill accelerate ongoing global efforts to develop better diagnostics, vaccines and therapeutics and answer important questions about the virus to support initiatives to safely reopen society.Press release.

Janssen Pharmaceutical Companieshas accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July. The randomized, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (response to vaccination), and immunogenicity (immune response) of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the U.S. and Belgium.Press release.

Illuminahas beenissued an Emergency Use Authorizationby FDAfor theCOVIDSeqTest, a high-throughput, sequencing-based, in vitro diagnostic workflow enabling the detection of SARS-CoV-2.COVIDSequses upper respiratory specimens, including a nasopharyngeal or oropharyngeal swab, and delivers sample receipt to result in 24 hours using theNovaSeq6000 Sequencing System. The differentiated diagnostic design includes 98 amplicons that target the full SARS-CoV-2 genome, creating accurate detection and high sensitivity. The workflow accommodates up to 3,072 samples perNovaSeqrun leveraging the S4 flow cell, and includes steps for viral RNA extraction, RNA-to-CDNA conversion, PCR, library preparation, sequencing and report generation. The key components leveraged include theNovaSeq6000, coupled with IlluminaTagmentationlibrary preparation technology, and the DRAGENCOVIDSeqTest Pipeline for rapid reporting.COVIDSeqis currently available to a limited number of early access sites and is expected to be more broadly available this summer.Press release.

TheMilken Institutepublished an interactive COVID-19 Community Explorer, allowing users to determine whatcommunity-wide risk factorscan make certain areas more vulnerable to the virus.At this time, COVID-19 fatalities are disproportionately higher among Black and Latino populations, older adults, and individuals with hypertension and diabetes. In developing this multimedia platform, the Milken Institute Research Department set out to understand what commonalities exist in communities more likely to see a potential resurgence with the virus. The new tool features: an interactive map allowing users to toggle between community characteristics in relation to COVID-19 cases and deaths inmore than 2,800 counties; an interactive map highlighting the 100 most affected communities across the country; and a table summarizing the key health and social characteristics of the most and least affected counties nationwide.More information.

Researchers from theSpanish National Research Council(CSIC)areleading a projectthat aims touse the CRISPR genetic editing toolto destroythe RNA genome of SARS-CoV-2.Thefunctionality and non-toxicity of CRISPR reagentswill initially be testedin zebrafish embryos,followed bytestingagainst RNA viruses andfinallycells infected with the current coronavirus. If successful, the next step would be to testthe therapeutic strategyon mice.Collaborators areNational Center for Biotechnology-CSIC, theAndalusian Center for Development Biologyand theCIBER-ISCIII.The projects goal is toprograma Cas13d proteinso that it cuts the coronavirus genome, promoting its destruction by the cell.Press release.

ANational Science Foundation COVID-19 Rapid Response Research granthas been awarded toa pair ofTexas Tech Universityevolutionary biologiststoinvestigate how bats adapted to the SARS-CoV-2 virusand if they might offer a solution to the pandemic.Bats are known to tolerate viruses well,but it is uncertain how.One possibility is that they dampen their immune response.By findingout how the immune system responds differently in batsthan humans,researchers hope they can informclinicians on howtoreplicate that inpeople. Their approach will be to examine bat genome assemblies from 10 species to identify patterns of gene duplication, gain and loss and relate those patterns to differences in how bats respond to viral infection.Texas Tech is well positioned for such research as the home of theNatural Science Research Laboratory, a repository of hundreds of thousands of preserved animal tissue specimens that researchers can use for projects just like this one.Press release.

Twist BioscienceandSerimmunearecollaborating toidentify and evaluate SARS-CoV-2 therapeuticantibody candidatesfrom Twist libraries.The collaboration will evaluate existing Twist antibody candidates that bind with high affinity to either SARS-CoV-2 S1 spike protein or the human ACE2 cellular receptor, usingSerimmunesSerum Epitope Repertoire Analysis (SERA) platform, which maps the antigenic targets of antibody repertoires. Epitopes identified in the first phase will then be used to re-screen Twists proprietary synthetic antibody discovery libraries to identify and evaluate new candidates while at the same time further increasing the specificity of antibody candidates. Twist will be responsible for advancing all antibodies resulting from the collaboration.Press release.

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COVID-19's Achilles' Heel, Other News From the Bio-IT Community - Bio-IT World

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Being a human guinea pig: What it’s like taking part in the Coronavirus vaccine trials – ITV News

§ June 12th, 2020 § Filed under Genetically Modified Humans Comments Off on Being a human guinea pig: What it’s like taking part in the Coronavirus vaccine trials – ITV News

Charlotte Cross Environment Correspondent

When I told my family that Id signed up to volunteer for the human trials of a new Covid-19 vaccine, the first thing my brother said was: You know this is how the zombie apocalypse starts, right?

The plot twist, he added, would be that it wasnt the disease itself which brings about World War Z, but the attempts to find a cure.

So that was a reassuring thought to send me into my screening appointment on Monday. (In fairness, he has also volunteered to take me down should I develop a sudden craving for brains, so theres probably very little risk to the wider public.)

Once signed in, I learned a little more about the experimental inoculation being trialled.

Its being led by the University of Oxford, but with centres across the country - including Birmingham, Nottingham, Bristol, Southampton and Liverpool, among others - recruiting up to 10,260 volunteers.

The vaccine is called ChAdOx1 nCov-19. Its based on a weakened version of a virus which causes the common cold in chimpanzees, called an adenovirus, which has been genetically modified so it cant replicate in humans.

The researchers have then added a spike protein - part of what gives the Coronavirus its name - in the hope that the body will develop an immune response to this which will help protect people against future exposure.

Then theres the control group. Roughly half of those who sign up and get a jab wont receive ChAdOx1 nCov-19 at all, but a meningitis vaccine.

I signed up after hearing about the trials via a friend, who had shared an article from the Nottingham Post.

The study was looking for people between 18 and 55 who were otherwise healthy, who werent planning to get pregnant within the next year, and who were key workers - ie who will, as a fact of their jobs, be out in communities and are therefore at higher risk of exposure.

The more I read, the more I knew I had to do it. I ticked all the boxes. Aside from being a little nervous, there was no reason why I shouldnt do it - and Ive never considered being nervous of something a good enough reason not to plough on and do it anyway. It seemed like a good thing to do, and I couldnt rest on my laurels and let others shoulder all the burden.

At the screening, I had to undergo a physical examination, as well as give a urine sample (to ensure Im not already pregnant) and have blood tests. These would look for any blood abnormalities, as well as antibodies; anybody who has already had Covid-19, for example, might already have a level of immunity which would render a vaccination pointless, so that would exclude volunteers from being able to take part.

They also ensured all potential participants understood the risks involved. There are a few of the usual side effects to be aware of - temperature, discomfort at the injection site, etc - as well as a base warning that its still very new, meaning there could be side effects they dont know about yet.

This includes the risk of going into anaphylactic shock due to an unexpected allergic reaction; not to worry, though, those administering the vaccine are all trained in how to revive someone in that situation.

Yikes.

It took three days to get the results of my blood test back, and yesterday evening I got the call confirming I was eligible (ie I didnt have any antibodies already, nor did I have anything concerning in my bloods, which was a relief in itself).

The jab itself took place this morning.

Ive been assigned to a group which will (if we're not in the control group) receive approximately double the dose of ChAdOx1 nCov-19 than other groups; this will help them test what level of dosage will prove most effective.

The injection itself was about as pleasant as being poked in the arm with a sharp needle ever is, but managed to avoid anaphylactic shock, so cant complain too much.

I have to take paracetamol for the first 24 hours, and keep an e-diary for the first week detailing any and all symptoms and physiological oddities I might experience.

This is because theyre not just testing for efficacy, they also have to make sure its safe, of course.

The study will last for a year, during which time Ill have weekly Covid tests and regular blood tests to measure any exposure to the virus and my antibody response.

Of course, therell be nothing to report if Im in the control group, and it may be that the vaccine doesnt provide any protection at all even if I'm not.

But that wont mean its wasted time - its still a very important bit of work going on.

As with anything, its only by doing the tests that well know whether it works or not.

And I did come out to a rather sweet message from my brother, who - after sending a zombie gif, obviously - said he was proud of me.

Youre trying to make the world a better place, he said.

Thats all I - and my 10,259 fellow guinea pigs - can hope for.

Last updated Fri 12 Jun 2020

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Being a human guinea pig: What it's like taking part in the Coronavirus vaccine trials - ITV News

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Mouse model of COVID-19, key in accelerating research, developed by Washington U. – STLtoday.com

§ June 12th, 2020 § Filed under Genetically Modified Humans Comments Off on Mouse model of COVID-19, key in accelerating research, developed by Washington U. – STLtoday.com

Brett Case sterilizes his suit before working with the virus that causes COVID-19. Case and colleagues at Washington University School of Medicine in St. Louis have developed a mouse model of COVID-19 that is expected to speed up the search for drugs and vaccines for the potentially deadly disease. (Photo by Matt Miller, for Washington University)

Testing how potential drugs and vaccines work in mice before moving to primates or humans is more efficient, saves money and is safer for people, he said.

Mice are unable to naturally get infected with the coronavirus that causes COVID-19.

In people, the virus latches onto a protein called ACE2 on the surface of cells in the respiratory tract. The human ACE2 protein is different than the mouse ACE2 protein. The virus is unable to attach to mouse protein.

During the SARS epidemic in 2003, researchers created a strain of genetically modified mice born with the human ACE2 protein so they could study SARS.

After the epidemic, however, interest waned. The mice colonies closed, and their embryos were frozen.

The emergence of COVID-19, which is similar to SARS, triggered a rush to begin breeding the mice again. But theres still not enough of the genetically altered mice for researchers trying to study the disease.

Most investigators and most drug companies and vaccine companies dont have access to them, Diamond said.

Researchers needed a faster way to obtain mice. Diamond and his team decided to try introducing the human ACE2 protein into mice temporarily.

To do this, they inserted the gene for the human ACE2 into a mild respiratory virus called adenovirus. At the same time, they disabled the adenovirus ability to multiply.

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Mouse model of COVID-19, key in accelerating research, developed by Washington U. - STLtoday.com

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