San Francisco-based Vir Biotechnology and its chief executive officer, George Scangos, believe it has a terrific antibody therapy against SARS-CoV-2, the virus that causes COVID-19. But is it too late to the game?
San Francisco-based Vir Biotechnology and its chief executive officer, George Scangos, believe it has a terrific antibody therapy against SARS-CoV-2, the virus that causes COVID-19. But while most of the world has heard of the antibodies developed by Eli Lilly and AbCellera, which received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA), and the cocktail by Regeneron Pharmaceuticals, which was used to treat President Trump (and has yet to receive an EUA), nobody’s really heard much about Vir’s therapeutic.
In its third-quarter financial report yesterday, Scangos said, “I am proud of the Vir team’s effort and success in accelerating our lead SARS-CoV-2 product candidate, VIR-7831, into a global Phase III trial, particularly in light of the more than 141,000 COVID-19 infections recently reported in a single day in the U.S. We expect to share initial results from the trial as early as January and look forward to advancing VIR-7831 into new patient populations alongside the initiation of a Phase Ib/IIa trial for our second investigational SARS-CoV-2 neutralizing antibody, VIR-7832. Simultaneously, we continue to advance our broader portfolio of product candidates for chronic hepatitis B, influenza A and HIV, as we seek to address some of the world’s most challenging infectious diseases.”
Vir has partnered with UK company GlaxoSmithKline on one of the antibody therapies and expects to begin a National Institutes of Health (NIH) Phase III trial in more-severe COVID-19 patients in addition to its own Phase III trial, beginning in the first quarter of 2021. Their own trial will be for preventing symptomatic COVID-19 infection.
This late-to-the-party component has caused company stock to take a hit. It was already down this year in August by $55 per share and in this week alone lost 21% of its value, closing Tuesday at $25.84.
“Look, they,” he said, referring to Lilly, Pfizer-BioNTech, and Gilead, “have data; we have not yet come out with any data. They are larger companies with better, well-oiled machines, certainly in Washington and also on the PR front. Having been in bigger companies and seen what they can do—we’re not as aggressive as they are.”
Scangos previously led Exelixis and Biogen, so he’s familiar with larger companies first-hand. He went on to say, “But, you know, all that’s temporary and, in the end, you either get good data or you don’t. We’re quite confident about our antibody and our approach.”
Scangos indicates their antibody approach is different than that of Lilly and Regeneron. Vir’s VIR-7831 was chosen based on its potent ability to neutralize the virus, kill infected cells, offer a higher barrier to resistance and achieve high concentrations in the lungs. On October 6, GlaxoSmithKline and Vir expanded the Phase III COMET-ICE trial of VIR-7831 in patients with COVID-19 at high risk of hospitalization. An independent Data Monitoring Committee recommended expansion of the study on September 30.
At the time, Hal Barron, chief scientific officer and president R&D for GSK, said, “Given the urgent patient need I am very pleased that we have progressed VIR-7831 from preclinical studies to a Phase III trial in only six months since announcing our collaboration with Vir. We believe this neutralizing antibody’s high barrier to resistance, notable effector function, and enhanced delivery into the lung suggest it has best-in-class potential in the fight against this global pandemic.”
It may be better than the others currently working their way toward emergency use authorization—certainly Scangos seems to think so. “We think we have a chance of being more efficacious,” he told the San Francisco Business Journal. “I think what’s important is to keep our heads down and get our jobs done and let the data speak.”