Vir Advances Antibodies Against COVID-19, CEO Leads BIO’s Coronavirus Outreach

Xconomy National — 

Scrip talked to George Scangos about his dual roles in the pandemic response, helming Vir as the company tests antibody and siRNA approaches while working with BIO to facilitate coronavirus collaborations.

George Scangos made a surprising shift when the former Biogen CEO left the world of big biotech to lead an infectious disease-focused start-up. Vir Biotechnology (NASDAQ: VIR) emerged in early 2017 with $150m and quickly brought its fundraising total later that year to more than $500m. The company went public late last year and Vir’s participation in the search for a coronavirus treatment has thrust the company into the spotlight in the last month, and elevated Scangos’s profile once again since he’s also leading BIO’s outreach to biotech firms to help get their coronavirus ideas from concept to clinical trials.

Vir’s stock has surged from $12.15 at the start of the year to $39.76 as of 20 March as it revealed three different partnerships to manufacture and develop antibodies and short interfering RNA (siRNA) medicines to treat COVID-19.

In an interview with Scrip, Scangos noted that many companies want to apply their expertise to the rapid search for COVID-19 vaccines and cures, but they don’t know where to start and don’t have the resources to go it alone.

“There are a number of biotech companies who have either early-stage research programs, marketed products or technologies that they would like to test to see if they have the capability to do something for COVID,” Scangos said. “One of the things BIO would like to do is facilitate interactions between companies who have complementary strengths, so that they can work together.”

He noted that companies are willing to form partnerships now to get work started rapidly and work out the commercial details later. That’s what his company did when it signed an agreement to have Biogen manufacture antibodies that Vir is advancing as potential treatments for COVID-19.

“It is an opportunity for the biotech industry and the companies in that industry to step up and work together collectively so that we can do something to head off this pandemic,” Scangos said. “My role has been to work with the staff at BIO and the members of the board at BIO to make those things happen. The other function I think BIO can serve is information, not only to its member companies but to the public and to other groups that are wanting to know what it is that BIO can do and what it is doing.”

San Francisco-based Vir’s employees are largely working from home with the exception of scientists who work in the lab, as the state of California has ordered residents to shelter in place to reduce the spread of the coronavirus.

“Everybody at Vir and I think across the industry is working under conditions that they’re not used to working in and people have been working flat out. The day starts really early and it goes very late,” Scangos said. He noted that Vir and others across the biopharmaceutical industry “feel an incredible sense of urgency” to bring forward COVID-19 treatments and vaccines.

Using Antibodies To Neutralize Infections

One of the technology platforms that Vir is applying to COVID-19 is its antibody platform, which the company uses to isolate antibodies from patients who have recovered from infectious diseases and then engineers those antibodies to enhance their therapeutic effects.

“We have done that repeatedly in the past with success,” Scangos said. “During one of the Ebola outbreaks we had isolated, from a patient who recovered from Ebola, antibodies to Ebola. We screened many thousands of antibodies in order to find two that were capable of actually blocking an Ebola infection and seemed to have other properties.”

One of those, called mAb114, was isolated by one of Vir’s scientists as part of a collaboration with the National Institutes of Health (NIH), which tested the antibody and an antibody therapeutic from Regeneron Pharmaceuticals (NASDAQ: REGN) to see how each candidate worked in Ebola patients; both were more effective than Mapp Biopharmaceutical’s ZMapp.

MAb114 is being tested in an NIH-led Phase 2/3 trial in Africa with initial data published last November in the New England Journal of Medicine. Ridgeback Biotherapeutics LP entered into a patent license agreement with the National Institute of Allergy and Infectious Diseases for mAb114 in November 2018 and is moving it forward with the goal of eventual US Food and Drug Administration approval. Vir retains an economic interest in mAb114 and may be eligible for payments.

Vir’s antibody platform also yielded VIR-2482 for prophylactic use against influenza A, which the company is testing in a Phase 1 clinical trial in human volunteers. VIR-2482 is engineered with a long half-life that should cover patients for the entire flu season, which typically is about five to six months long.

“We have a pan-flu antibody that recognizes all strains of influenza A that have arisen since the 1918 pandemic. It also recognizes many strains of flu that have never been in humans, so avian strains that could be the source of the next pandemic, and we’re bringing that forward as a better way to prevent flu than a vaccine,” Scangos said.

He noted that flu vaccines usually are effective against only about 40% of flu strains in a given season and they are even less effective for the elderly and other high-risk populations, because manufacturers have to guess in the fall which strain will be active a year later before they manufacture their vaccines in the spring. Also, not everyone who receives the flu vaccine generates an effective immune response.

“We’re giving them the antibody that provides the response, so it can overcome both of those limitations,” Scangos said. “And we have really effective antibodies that look like they’re effective against Zika, dengue and other infections. We are using the same approach for coronaviruses.”

Vir isolated a large number of antibodies that were capable of neutralizing SARS after the last SARS epidemic. In anticipation that additional outbreaks would emerge, the company screened some of those antibodies for their ability to neutralize coronaviruses before the emergence of SARS-CoV-2.

“We had a running start to screen our antibodies against CoV-2, which we have done, and at the same time we had gone back to SARS patients and identified some additional antibodies,” Scangos said. “We have serum from recovered COVID patients, so we have a large number of antibodies that are in process and our goal is to move those forward and get them through manufacturing and into clinical testing as soon as we can.”

Vir has not given any guidance on when it will identify a COVID-19 antibody that can be taken into clinical trials, but it anticipates making a more specific disclosure within a few weeks or months.

Engaging Partners For Manufacturing Early On

“Manufacturing obviously is key and the rate at which you can actually generate good cell lines and manufacture antibodies from them is going to be one of the bottlenecks here,” Scangos said. “We have begun, already, working with WuXi and Biogen and we have transferred to them the first of the antibodies, and they’re already working on them.”

Vir and WuXi Biologics agreed in February to work together on the global development, manufacturing and commercialization of treatments for COVID-19. WuXi’s commercial rights are limited to Greater China, while Vir maintained rights in all other markets.

The company also expanded its existing agreement with Alnylam Pharmaceuticals (NASDAQ: ALNY). for the development of RNA interfering (RNAi) therapeutics that treat infectious diseases to include therapies that target SARS-CoV-2. Vir will tap into Alnylam’s work to deliver novel conjugates of siRNA, which mediate RNAi, to the lungs and will lead development of any drug candidates under the agreement.

“The issue for biotech companies, like all pre-commercial companies, is you don’t have infinite cash in the bank,” Scangos said. “Vir is in the fortunate position that we were able to raise a substantial amount of money, so we are able to do that.”

The company, which plans to release its fourth quarter and full-year 2019 financial report on 24 March, had $320.2m as of 30 September based on its prior venture capital and private equity fundraising. In addition to those significant funds, Vir grossed an additional $142.9m from its IPO last October, and through its work on the novel coronavirus it has a relatively near-term opportunity to bring a revenue-generating product to market.

“When we started working [on COVID-19], it wasn’t clear whether this was purely something we were doing because it was the right thing, where we are going to help head off an epidemic,” Scangos said. “Increasingly, this looks like a serious global pandemic that is not going to go away soon. If that is the case, there is an interesting commercial opportunity as well as doing the right thing. We think it is a very interesting and important thing for Vir to be doing and other companies as well.”

COVID Trials Moving Quickly, Other Programs Continue Without Disruption

The CEO said Vir’s COVID-19 efforts have not impacted the company’s other programs, which include the Phase 1 influenza A antibody VIR-2482 and the Phase 2 hepatitis B virus (HBV)-targeting siRNA Vir-2218 under the partnership with Alnylam. Both are expected to advance later this year and the firm will move two new assets into the clinic.

“We have a group of people making sure that our other programs are not impacted by the COVID work and then we’ve got a group of people working on COVID,” Scangos said.

He noted that Vir has not yet seen any delays in its ongoing clinical trials nor in its plans to initiate additional trials, but said some impact may be felt as the coronavirus pandemic continues to unfold globally.

The CEO said Vir is pushing its COVID-19 programs forward “aggressively” and anticipates that those clinical trials will enroll quickly given the dire and growing need for treatments.

Meanwhile, he said the company continues to seek out partners for both its COVID-19 and non-coronavirus programs.

“We are always in discussions on our other programs as well and I don’t think our partnering strategy has changed as a result of the COVID situation,” Scangos said. “We don’t have an urgent need for cash right at this moment, so we’re going ahead and if we can get the right partnerships, we’ll find them. We don’t feel a compelling need to do that for the cash.”

This article was first published on 20 March 2020 in Scrip.

Image: iStock/Christoph Burgstedt