Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2021.
“2021 was a transformative year in which we delivered our first blockbuster medicine, sotrovimab, to COVID-19 patients as a result of prescient scientific insights from our R&D team and the rapid development and disciplined execution of an integrated strategy by the entire company alongside our collaborator, GSK. Simultaneously, we continued to advance our robust and diverse portfolio of compounds with the potential to address hepatitis B, influenza A, HIV and more, with multiple clinical value drivers expected in 2022,” said George Scangos, Ph.D., chief executive officer of Vir Biotechnology.
Dr. Scangos added, “In the year ahead, we plan to share important data readouts from multiple Phase 2 combination trials aimed at developing a functional cure for HBV; report additional data from our Phase 1 study evaluating our HIV T cell vaccine; initiate a Phase 2 trial for our potential universal prophylaxis for influenza A; report new data evaluating sotrovimab as prophylaxis for immunocompromised COVID-19 patients and as treatment for hospitalized COVID-19 patients; and advance new innovative pan-coronavirus solutions. Importantly, our strong cash position allows us the flexibility to invest in additional internal and external opportunities.”
Corporate Update
COVID-19
- The Company has made significant progress increasing global patient access to sotrovimab in collaboration with GlaxoSmithKline (GSK). Sotrovimab has been granted Emergency Use Authorization (EUA), temporary authorization or marketing approval (under the brand name Xevudy®️) in more than 40 countries.
- To date, binding agreements have been received for the sale of approximately 1.7 million doses of sotrovimab worldwide.
- In November, the Company and GSK announced the sale of more than 750,000 doses globally to date, including multiple contracts with the US government. Approximately 90% of those doses were delivered in 2021 and the remainder are expected be delivered throughout the first half of 2022. The delivered doses led to the recognition of $917.2 million of sotrovimab collaboration revenue in 2021.
- In January, the Company and GSK announced the sale of an additional 600,000 doses to the US government, which are expected to be delivered throughout the first quarter of 2022, and the sale of approximately 350,000 additional doses to other countries, which are expected to be delivered throughout the first half of 2022. Based solely on the binding agreements received to date, the Company expects to recognize approximately $1.1 billion of sotrovimab collaboration revenues when the doses are delivered in the first half of 2022.
- The Company and GSK expect to manufacture approximately 2 million doses in the first half of 2022 and additional doses in the second half of 2022.
- During and following the fourth quarter, the Company announced preclinical data generated through pseudovirus testing demonstrating that sotrovimab retains neutralizing activity against the highly divergent Omicron variant (B.1.1.529).
- In February, the Company published pseudovirus data demonstrating a 16-fold shift in neutralization activity against the Omicron BA.2 subvariant. Vir’s BA.2 results were derived from 10 independent experiments that were conducted using an optimized pseudovirus assay. This is the same assay that was used to generate data for previous variants. These data have been shared with regulatory agencies around the world. Initial feedback from the FDA question Vir’s conclusion that the 500 mg IV dose of sotrovimab retains activity against the BA.2 Omicron subvariant based on Vir’s current modeling assumptions, and the FDA has asked for additional data to support Vir’s position. The agency also requested safety data for higher doses. Both have been provided to the agency and Vir is awaiting further correspondence.
- The Health Care Provider Fact Sheet was recently updated to show that sotrovimab’s neutralization activity was reduced an average fold change in EC50 value of 16-fold against the SARS-CoV-2 Omicron B.1.1.529/BA.2 spike variant compared to wild-type. The Fact Sheet also noted that the clinical relevance of the 16-fold reduction in sotrovimab activity against the SARS-CoV-2 Omicron B.1.1.529/BA.2 variant is unknown.
- As of February 24, 2022, the FDA noted on its EUA website that sotrovimab is currently authorized in all US regions until further notice by the agency.
- In November, the Company announced the results of the Phase 3, randomized, open-label, COMET-TAIL trial, which achieved its primary endpoint, demonstrating that 500 mg intramuscular (IM) administration of sotrovimab (n=376) was non-inferior to 500 mg intravenous (IV) administration (n=378) for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents. Low rates of serious adverse events (≤1% in both arms) were observed. Based on the results of the COMET-TAIL trial, in January, the Company and GSK submitted an application to the U.S. Food and Drug Administration (FDA) requesting an amendment to the EUA for sotrovimab to include IM administration.
- The Company and GSK plan to submit a Biologics License Application (BLA) for sotrovimab to the FDA in the second half of 2022.
- The Company and GSK are collaborating to assess the use of sotrovimab in uninfected immunocompromised patients to determine whether sotrovimab can prevent symptomatic COVID-19 infection. Two Phase 3 trials are expected to start in the second quarter of 2022. One is a platform trial and one is a company sponsored trial, COMET-STAR. The primary endpoint for both trials is incidence of symptomatic PCR-confirmed COVID-19. The analysis of the primary endpoint of COMET-STAR will be event driven, and could be as early as the second half of 2022.
- Sotrovimab is also being evaluated among patients hospitalized with COVID-19 in the United Kingdom as part of the Randomized Evaluation of COVID-19 Therapy (RECOVERY) Trial. Initial data are expected in the second half of 2022.
- The United Kingdom’s National Health Service-supported AGILE initiative evaluating VIR-7832 in a Phase 1b/2a trial of adults with mild-to-moderate COVID-19 remains ongoing. To date, no safety signals have been reported for the 50 mg, 150 mg and 500 mg dose cohorts. The first patient in the Phase 2a portion of the trial was dosed in February. Additional data are expected in the first half of 2022.
Chronic Hepatitis B Virus (HBV)
- The Company has continued to advance its broad HBV portfolio aimed at the pursuit of a functional cure.
- In November, the Company presented new data evaluating the potential for VIR-2218 and VIR-3434 to achieve a functional cure for chronic HBV at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®.
- 24-week data evaluating VIR-2218 in combination with PEG-IFN-α, an approved immune modulatory agent, demonstrated that concurrent initiation of VIR-2218 and PEG-IFN-α therapy resulted in earlier and more substantial HBsAg reductions compared to VIR-2218 alone or with PEG-IFN-α following a VIR-2218 lead-in. Also, three participants achieved HBsAg loss below the lower limit of quantification by Week 24; two of three achieved anti-HB seroconversion.
- A single dose of 6 mg, 18mg, or 75 mg of VIR-3434 resulted in rapid HBsAg reductions in most participants within approximately one week post-dose, and the largest and most sustained reductions in HBsAg were observed in the 75 mg cohort. VIR-3434 has been Fc engineered to include the XX2 “vaccinal mutation,” allowing it to potentially function as a T cell vaccine. No new safety signals were reported.
- In December, the Company and Gilead Sciences, Inc. (Gilead) initiated a Phase 2 trial to evaluate the various combinations of VIR-2218, selgantolimod (GS-9688), Gilead’s investigational TLR-8 agonist, and nivolumab, an approved PD-1 inhibitor, as a potential functional cure regimen for chronic HBV infection.
- In 2022, the Company expects data readouts from multiple trials evaluating VIR-2218 and VIR-3434:
- Initial data from the first cohorts of Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial of VIR-2218 in combination with VIR-3434, are expected in the first half of 2022.
- Additional data from the Phase 2 trial of VIR-2218 in combination with PEG-IFN-α are expected in the first half of 2022.
- Additional data from the Phase 1 monotherapy trial of VIR-3434 are expected in the first half of 2022.
- The Company’s collaborator, Brii Biosciences, continues to lead the Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the potential treatment of chronic HBV infection. Initial data are expected in the second half of 2022.
Other Pipeline
- Additional data from the proof-of-concept Phase 1 trial of VIR-1111, an investigational human immunodeficiency virus (HIV) T cell vaccine based on human cytomegalovirus (HCMV), to evaluate whether this new approach can elicit potentially protective immune responses that differ from other HIV vaccines, are expected in the first half of 2022. To date, no safety signals have been reported.
- Anticipating an increase in the incidence of influenza in the Northern Hemisphere this coming winter, the Company expects to initiate a Phase 2 trial evaluating VIR-2482 in the second half of 2022. Additionally, the Company and GSK are evaluating the potential of several next-generation monoclonal antibodies for influenza treatment and prevention, functional genomics applications for respiratory targets, and monoclonal antibodies for non-influenza diseases.
- In January, the Company announced an expansion of its collaboration with the Bill & Melinda Gates Foundation to include the advancement of innovative platform technologies in the development of broadly neutralizing antibodies designed to provide a “vaccinal effect” aimed at a functional cure of HIV and the prevention of malaria.