When Vir Biotechnology won the Fierce 15 award a few years back, infectious disease work was something of an outlier in life science R&D. But the company was adamant it was a clear and present danger to the world and one that needed addressing.
This has proven to be something of an understatement: One-quarter of the world is now hunkering down to weather the infectious storm that is COVID-19, and Vir’s insistence on the importance of infectious disease research is prescient to say the least.
Today, the biotech, helmed by former Biogen CEO George Scangos, says it has mapped out “multiple antibodies” that can “neutralize” SARS-CoV-2, the virus causing COVID-19.
The San Francisco biotech says it will kick-start a phase 1/2 clinical test as early as this summer, in “3 to 5 months.” Vir handed over its leading candidate to Chinese life science firm WuXi Biologics and Scangos’ former Big Biotech Biogen to shorten lead times—boy, does that seem to have worked.
“We are pleased with the rapidity of our progress and excited to move two development candidates into human testing as soon as possible,” said Scangos. “Stopping this disease will take a combination of prevention and treatment approaches. At Vir, we are fortunate that our existing antibody platform gave us a running start against COVID-19, and we have the internal and partnered capabilities to work on multiple approaches.”
Vir says the ability of its antibody to neutralize the SARS-CoV-2 live virus “has been confirmed in two separate laboratories” and explains that 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.”
It adds that the conservation of this epitope “will make it more difficult for escape mutants to develop” and therefore less able to outrun drug therapies.
This comes amid a major upscaling in R&D against the virus, which includes more than a dozen experimental and potentially repurposed drugs such as antivirals to treat the disease in more severe patients, as well as more than 40 vaccines also in progress to try to halt the disease from infecting people in the future.
Vir is looking at a two-pronged approach: It has engineered the Fc region of its lead development candidate with a half-life extending alteration to potentially extend the time over which the antibody provides protection, as well as a second alteration (“vaccinal” mutation) that increases short-term potency and, in animal models, leads to the generation of protective CD8+ T cells that may provide long-term immunity.
This alteration gives the antibody the potential to function prophylactically and therapeutically as well as to be able to induce long-term immunity (i.e., to function both as a therapeutic and a vaccine), it says, giving a major level of protection, should it work. (And caveats abound as to how many early-stage efforts never leave the lab.)
The lead development candidate is being produced with and without the vaccinal mutation, and Vir “intends to move both versions into human testing.”
It said it is also still on the lookout for additional antibodies from survivors of SARS-CoV-2, SARS-CoV-1 and other coronaviruses. “These antibodies may also be candidates to address the ongoing COVID-19 pandemic as well as coronavirus outbreaks that may occur in the future,” it said, adding: “Vir’s long-term goal is to identify pan-coronavirus antibodies that could be effective against most or all coronavirus outbreaks. Vir has used this same approach in the discovery and development of VIR-2482, a pan-influenza A antibody that the company is developing for the prevention of influenza A.”
With a market cap of $3.6 billion, Vir's stock shot up 14% in early trading this morning, following a typical trend that has seen a major lift to its shares since last month, when it first announced its attempts to combat the virus.