“Nature Publishes New Research from Vir Biotechnology Demonstrating the Capacity of Enhanced Monoclonal Antibodies to Induce Protective Adaptive Immunity to Viral Infection - BioSpace” plus 3 more

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• Nature Publishes New Research from Vir Biotechnology Demonstrating the Capacity of Enhanced Monoclonal Antibodies to Induce Protective Adaptive Immunity to Viral Infection - BioSpace
• Donald Trump appears to blame Gold Star families for coronavirus infection - The Mercury News
• Antibody treatments show promise on virus infections - Arkansas Online
• What we know - and don't know - about Trump's COVID-19 illness - Reuters

Nature Publishes New Research from Vir Biotechnology Demonstrating the Capacity of Enhanced Monoclonal Antibodies to Induce Protective Adaptive Immunity to Viral Infection - BioSpace Posted: 09 Oct 2020 06:12 AM PDT SAN FRANCISCO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology Inc. (Nasdaq: VIR) today announced the publication of preclinical research in an influenza animal model highlighting a new mechanism for enhancing the efficacy of monoclonal antibodies to treat viral infection and induce a protective response. Data demonstrate that selective engagement of an activating Fc receptor on dendritic cells by antiviral monoclonal antibodies induced protective CD8+ T cell adaptive responses. The paper, entitled "Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection," was published in the October 8, 2020 online edition of Nature. "In the past several years, we've gained a better understanding of how integral Fc mediated effector functions of monoclonal antibodies are for their therapeutic efficacy in pre-clinical models of neoplastic, infectious and inflammatory diseases," said Jeffrey V. Ravetch, M.D., Ph.D., study senior author and Theresa and Eugene M. Lang Professor and Head of the Leonard Wagner Laboratory of Molecular Genetics and Immunology at The Rockefeller University. "These approaches have been successfully applied to anti-tumor therapeutics and have resulted in improved clinical outcomes in a variety of oncologic diseases. Our present studies have uncovered a significant new mechanism by which antibodies, through their Fc region, can not only engage innate immune responses but activate adaptive T cell responses, thereby stimulating protective anti-viral immunity in these models." The research published in Nature focuses on the role of the Fc domain of monoclonal antibodies, regions with the capacity to bind to other immune cells through a family of receptors (the Fc receptors). By engineering antibodies with modified Fc domains to enhance binding to specific Fc receptors on innate immune cells, investigators observed an enhanced protective immune response. Certain modifications (GAALIE variants) were associated with activation of dendritic cells, as well as antiviral effector T-cells, indicating induction of the adaptive arm of the immune system, which is responsible for long-term immunity. Based on this research, monoclonal antibodies programmed with improved effector function represent a potential new approach in the design of therapeutic antibodies for both the prevention and treatment of infectious diseases. "By observing and learning from our body's powerful natural defenses, we have discovered how to maximize the capacity of antibodies through the amplification of key characteristics that may enable more effective treatments for viral diseases," said Herbert "Skip" Virgin, M.D., Ph.D., study co-author and executive vice president, research, and chief scientific officer of Vir. "These data may have significant implications across a wide range of infectious diseases, and we look forward to exploring the vaccinal potential of the GAALIE-engineered antibodies we are advancing through clinical development – VIR-3434 for chronic hepatitis B and VIR-7832 for SARS-CoV-2." The preclinical study was conducted by Dr. Ravetch and Stylianos Bournazos, Ph.D., of the Laboratory of Molecular Genetics and Immunology at The Rockefeller University, in collaboration with Dr. Virgin and Davide Corti, Ph.D., senior vice president of antibody research at Vir's subsidiary Humabs BioMed SA. "This type of exceptional collaborative partnership between cutting-edge science and clinical application has the potential to significantly improve our ability to address infectious diseases," stated Dr. Virgin. Vir is currently evaluating several monoclonal antibodies that have been Fc engineered to include the XX2 "vaccinal mutation" (or GAALIE variant) for which Vir has licensed exclusive rights for all infectious diseases.  About VIR-3434 VIR-3434 is a subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients. About VIR-7832  VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine. VIR-7832 is being developed by Vir and its partner GlaxoSmithKline plc (LSE/NYSE: GSK) as part of their broader collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2.  About Vir Biotechnology Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.  Vir Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "potential," "may," "will," "could," "expect," "plan," "anticipate," "believe," "estimate," "goal," "intend," "candidate," "continuing," "developing" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the ability of enhanced Fc mediated effector functions in enhancing the efficacy of monoclonal antibodies to treat viral infections and inducing a protective response in animal models, using an oncological therapeutic approach and enhanced effector function in the treatment of infectious diseases, the vaccinal potential of specifically engineered antibodies in the treatment of chronic hepatitis B and SARS-CoV-2, and statements around the company's plans to explore the vaccinal potential of engineered antibodies as it advances through clinical development of VIR-3434 for the treatment of chronic hepatitis B and VIR-7832 for SARS-CoV-2. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in treating chronic hepatitis B and neutralizing SARS-CoV-2, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact: Investors Neera Ravindran, M.D. VP, Head of Investor Relations & Strategic Communications nravindran@vir.bio +1-415-506-5256 Media Cara Miller VP, Corporate Communications cmiller@vir.bio +1-415-941-6746

Donald Trump appears to blame Gold Star families for coronavirus infection - The Mercury News Posted: 08 Oct 2020 11:31 AM PDT By Betsy Klein | CNN President Donald Trump appeared to place blame on Gold Star families for infecting him with Covid-19, Thursday, going a step further than previous comments speculating where he contracted the virus. The White House held an event honoring Gold Star families indoors, in the East Room, with no social distancing and few masks on the evening of Sunday, September 27. That gathering came one day after a Supreme Court event in the Rose Garden, where multiple attendees have subsequently tested positive. And it came after months of blatant disregard for basic public health guidance inside the White House, ultimately putting West Wing and residence staff and the President himself in direct risk of catching the virus. Video: 'Shell shock' in the White House "I got a lot of things doing. And again, when I want to say hello to Gold Star families, what I — I'm not going to be in a basement saying, 'Hey I can't see you as you traveled in from California and all the different places.' It's OK," Trump said Thursday morning during a call-in interview on Fox Business. "And I think at some point I would — it's a very — look, it's a tiny, tiny it's like a tiny little microscopic piece of dust. It gets into nose your mouth or your eye, frankly, or something else or you touch something. So, I understand, and then you get better," he added. The comments go further than Trump's previous suggestion during an interview with Fox News after senior adviser Hope Hicks' diagnosis that Hicks contracted the virus from a member of the military or law enforcement. "It's very, very hard when you are with people from the military or from law enforcement, and they come over to you and they want to hug you and they want to kiss you because we really have done a good job for them. And you get close and things happen," Trump told Sean Hannity hours before his diagnosis was publicly disclosed. There's no way to say conclusively how Trump and others contracted the virus, and just because someone tested positive sooner than someone else does not mean they were responsible for the infection. The White House placed a high reliance on unreliable rapid antigen tests, but has not put similar effort into rapid contact tracing to determine potential spread. Trump held numerous events actively shirking social distancing and mask wearing in the days, weeks and months before his infection, many of which were indoors. And hundreds of officials who were not in daily contact with the President, but regularly interact with key officials who were, were not regularly tested. The White House has declined to provide a full list of attendees in the East Room, but CNN has reached out to some of the families and organizations known to be in attendance. Timothy Davis, the president and CEO of the Greatest GENERATIONS Foundation, said in a statement that all Gold Star Family attendees were tested by the White House ahead of the event, and, like the Supreme Court event, all tested negative for coronavirus. The rapid antigen tests administered by the White House are known to deliver a high rate of false negatives. "Considering it has been 12-days since the event, All Gold Star family are all doing well and exhibit no symptoms of Covid-19," Davis said in the statement, adding that the group is providing a "daily update" to the White House Office of Public Liaison. Though the White House has claimed all contact tracing is complete, New York Times White House correspondent and CNN contributor Michael Shear, who tested positive for the virus following direct interaction with White House officials, told CNN late Tuesday that there's been no outreach by the White House to do contact tracing or to follow up on his condition. And at least one other White House official told CNN that they've also alerted officials that they have had direct contact with positive White House personnel, and received no guidance on how to proceed. That Trump would place blame on Gold Star families says much about his general attitude toward the solemn club of military families who have lost a son, daughter, brother, sister, husband, wife, father or mother. During the 2016 election, Trump went after Khizr Khan, whose son, Army Capt. Humayun Khan, died in Iraq in 2004, after Khan spoke out against Trump at the Democratic National Convention. "Who wrote that? Did Hillary's script writers write it?" Trump said in an interview at the time. "I think I've made a lot of sacrifices. I work very, very hard." Trump also repeatedly attacked Sen. John McCain, who, he said, was "not a war hero," despite being captured in Vietnam and tortured as a prisoner of war. Despite that, Trump has claimed to be a champion of the military, tweeting, "STRONGEST EVER MILITARY. VOTE!" from his hospital suite at Walter Reed National Military Medical Center Monday. The-CNN-Wire ™ & © 2020 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

Antibody treatments show promise on virus infections - Arkansas Online Posted: 09 Oct 2020 02:09 AM PDT WASHINGTON -- They're not cures, but experimental antibody drugs like the one President Donald Trump was given are among the most promising therapies being tested for treating and preventing coronavirus infections. Eli Lilly and Regeneron Pharmaceuticals Inc. are asking the U.S. government to allow emergency use of their antibody drugs, which aim to help the immune system clear the virus. The medicines are still in testing; their safety and effectiveness are not yet known. Trump is among fewer than 10 people who were able to access the Regeneron one under "compassionate use" rules, without enrolling in a study. How do they work? Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help eliminate it. Vaccines mimic an infection to spur antibody production. But it can take several weeks after a vaccine or natural infection for the most effective antibodies to form. The experimental drugs are concentrated versions of specific antibodies that worked best against the coronavirus in lab and animal tests. In theory, they start helping right away. The one-time treatment is given through an IV. [CORONAVIRUS: Click here for our complete coverage » arkansasonline.com/coronavirus] How do the drugs differ? Regeneron is using two antibodies to enhance chances its therapy will work even if the virus evades one. The company made a successful Ebola combo antibody treatment this way. Lilly is testing two different antibodies -- one with the Canadian company AbCellera and another with a Chinese company, Junshi Biosciences -- individually and in combination. Others testing similar drugs are GlaxoSmithKline and Vir Biotechnology Inc., which says it has engineered antibodies to last longer than they usually do. Amgen, Adaptive Biotechnologies and the Singapore biotech company Tychan Pte Ltd. also have studies underway. When might they be available? Eli Lilly and Regeneron have asked the Food and Drug Administration for emergency authorization. During public health emergencies the FDA can speed drugs to market based on a lower standard of evidence than is normally required. Drugmakers need only show that the expected benefits of their therapies outweigh the risks for treating covid-19. There is no deadline for the FDA to rule on the drugs, but it typically makes decisions on such emergency applications within days or weeks. Who would get them? Researchers are still trying to determine the best candidates for antibody treatment. Some studies involve newly infected people to see if early treatment can lower the risk of becoming sick. Other studies in hospitalized patients aim to prevent serious illness, complications or death. Researchers also are testing these drugs to try to prevent infection in people at high risk of it, such as health workers, housemates of people with covid-19, and nursing home workers and residents. Will there be enough for everyone? It depends on how potent the drugs prove to be, something still being studied. If a high dose is needed to be effective, it will mean that fewer people can be treated with limited supplies. Regeneron says it has enough doses for approximately 50,000 patients and expects 300,000 available within the next few months. Under a $450 million contract, the federal government has agreed to buy initial supplies of Regeneron's drug and distribute them at no cost to U.S. patients. Lilly says it expects to have 1 million doses this year of the single antibody that it submitted to FDA. However, the company's research has focused on a combination of two antibodies to treat covid-19 patients. Lilly said it expects to have just 50,000 doses of that combo this year. What's the evidence that they work? Lilly and Regeneron have revealed only partial results in news releases; they haven't been published or vetted by independent scientists. Lilly said Wednesday that its two-antibody combo reduced symptoms, the amount of virus, hospitalizations and ER visits for patients with mild or moderate covid-19. The results are an interim look at a mid-stage study in which 112 people received the antibodies and 156 got a placebo. The amount of virus was significantly lower 11 days later in those given the drug -- the main goal of the study. About 5.8% of patients given placebo required hospitalization or an emergency room visit versus 0.9% of those given the antibodies.

What we know - and don't know - about Trump's COVID-19 illness - Reuters Posted: 08 Oct 2020 03:08 PM PDT By Carl O'Donnell 6 Min Read (Reuters) - U.S. President Donald Trump revealed early on Oct. 2 that he had tested positive for the coronavirus, but several questions about the course of his illness remain unknown. The following is some of what is known and what is still unclear about the president's bout with COVID-19. Slideshow ( 5 images ) Who infected President Trump when? These are both questions that have not been answered as the White House has repeatedly refused to say when the president last tested negative for the coronavirus - information essential to tracing the timeline of when and where he was likely infected. Health experts say the timing of his positive test results suggest he likely contracted the illness in late September. On Sept. 26, Trump hosted a ceremony in the White House Rose Garden to announce his Supreme Court nominee, Amy Coney Barrett. The mostly outdoor event was attended by more than 100 people, most not wearing masks and with no social distancing. Whether Trump was infected at the event or infected others there is unknown. At least eight attendees, including the president, first lady and some top aides, tested positive afterwards, the New York Times reported. Trump may have contracted the virus from a member of his staff. On Oct. 1, White House aide Hope Hicks was diagnosed with COVID-19 and began to self-isolate. Hicks travels regularly with the president on Air Force One and accompanied him to Ohio for the presidential debate the previous Tuesday and to Minnesota for a campaign event on Wednesday. Several other members of his staff, including senior White House adviser Stephen Miller, have since tested positive for COVID-19. Some experts said Trump's symptoms and those experienced by Hicks first appeared too close together to make it likely that Hicks infected the president. It generally takes 5 to 7 days after infection for COVID-19 to be detected on a typical molecular diagnostic test, said Otto Yang, a physician at UCLA Health. The Wall Street Journal reported Trump first tested positive on a rapid test used for screening White House staff earlier on Thursday that was later confirmed by a more accurate lab test. He did not disclose his positive test until about 1 am ET (0500 GMT) after the news broke that Hicks had tested positive. Was the president seriously ill? Trump was ill enough to cause concern among his doctors and to convince him he should be treated at a hospital and not at the White House. Several pieces of evidence indicate Trump may have been seriously ill, but his aides and medical team have provided conflicting information. Sources told Reuters he suffered a mild fever and his doctor at the time said he was "fatigued but in good spirits." At briefings, his doctor gave unusually rosy reports while avoiding specific questions that would give a much more clear picture of Trump's condition. For example, they declined to discuss his lung scans or say whether he had pneumonia or whether blood tests showed markers for inflammation, a sign of more serious illness. Trump was hospitalized at Walter Reed National Military Medical Center in Maryland from Friday, Oct. 2 to the following Monday and had two known instances of low oxygen levels, a sign of more serious illness. He received many of the medicines that have shown some efficacy against COVID-19 in clinical trials, painting a confusing picture of how severely ill he may have been, physicians told Reuters. He received an experimental dual antibody therapy developed by Regeneron Pharmaceuticals Inc REGN.O that is so new it does not yet have an official name. That treatment can be given early in the course of the disease. He also received a five-day course of Gilead Sciences Inc's GILD.O antiviral remdesivir, which is often used for severely ill patients but can be given early in the illness. And he is taking the steroid dexamethasone, which experts have said should be reserved to prevent death in severely ill COVID-19 patients. Because the steroid suppresses the immune system's natural response, it can actually worsen a more mild illness, Yang said. Trump's physician said blood samples taken on Monday show the president had protective antibodies, but those were likely the Regeneron antibodies rather than a natural response, the company and other health experts said. In a series of videos this week, Trump proclaimed himself cured, possibly immune, and touted the benefits of the Regeneron therapy. U.S. infectious disease chief Dr. Anthony Fauci noted on Thursday that we do not know if the president is well, because patients can unexpectedly go downhill more than a week after symptoms begin. Has the president infected anyone? The U.S. Centers for Disease Control and Prevention recommends that patients avoid contact with others for 10 days after the onset of symptoms. That means Trump should assume he is contagious through Saturday, Oct. 10, if he was first symptomatic on Oct. 1. People are believed to be at their most contagious in the days just before symptoms arise. Since it is not known when Trump last tested negative, he could have been spreading the virus for days before testing positive. Trump put some of his Secret Service detail at risk on Oct. 1, when he left the hospital in a motorcade to wave to supporters, experts said. He and others in his car wore masks but were in close proximity in the hermetically sealed vehicle. Upon returning to the White House, Trump immediately removed his mask for photo ops, potentially putting those around him at risk. On Thursday, the president said he is no longer contagious, which some experts say is unlikely. The White House has not said whether he has tested negative. Reporting by Carl O'Donnell in New York; additional reporting by Deena Beasly, editing by Peter Henderson and Bill Berkrot

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