Vir Biotechnology Provides Corporate Update and Reports Second Quarter 2021 Financial Results

SAN FRANCISCO, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the second quarter ended June 30, 2021.

“Vir made strong progress this quarter across our extensive infectious disease portfolio, the most notable of which is that our monoclonal antibody sotrovimab is now available for patients who become ill with COVID-19 and are at high risk for hospitalization,” said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. “In lab experiments, sotrovimab retains efficacy against circulating variants of concern and interest, including the Delta, Delta Plus and Lambda variants. Additionally, its low dose may allow for more convenient intramuscular administration, which is now being tested in two clinical trials. Sotrovimab has been authorized for emergency use and, with our partner GSK, we have established supply agreements with multiple countries around the world. Together, we plan to submit a Biologics License Application to the FDA later this year and, in May of this year, the EMA began a rolling review of data to support a marketing authorization application in Europe.”

Dr. Scangos continued, “Beyond our lead program, we have built a deep and broad hepatitis B portfolio in our quest to develop a functional cure. We recently initiated a Phase 2 combination trial of VIR-2218 with VIR-3434, and another Phase 2 trial evaluating VIR-2218 with Gilead’s investigational TLR-8 agonist and nivolumab is planned to start soon. We also plan to share additional data later this year from our combination trial of VIR-2218 with pegylated interferon alfa and our VIR-3434 monotherapy trial.”

Corporate Update

COVID-19 Updates

• During and after the quarter, sotrovimab was authorized for emergency use in the U.S., received a positive Committee for Human Medicinal Products (CHMP) scientific opinion in the European Union (EU), and was granted interim, emergency or conditional authorization in Bahrain, Canada, Italy, Kuwait, Qatar, Singapore and the United Arab Emirates.
• Together with GlaxoSmithKline (GSK), we have established supply agreements with multiple governments around the world and continue to work actively to make sotrovimab available to patients in need. In July, the companies also signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab. 
• Updated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against currently circulating variants of concern and interest of the SARS-CoV-2 virus including Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617.2), Delta Plus (AY.1 or AY.2), Epsilon (B.1.427/B.1.429), Eta (B.1.525), Gamma (P.1), Iota (B.1.526), Kappa (B.1.617.1) and Lambda (C.37), as well as new variants from Bristol (B.1.1.7+E484K) and Cameroon (B.1.619), which predominantly includes both N440K and E484K mutations that may lead to reduced activity for other neutralizing monoclonal antibodies against the SARS-CoV-2 virus. The Company and GSK are continuing to evaluate the ability of sotrovimab to maintain activity against new and emerging variants through in vitro studies.
• In April, the first patient was dosed in the United Kingdom National Health Service-supported AGILE initiative. The trial initiative is the first to evaluate VIR-7832 in a Phase 1b/2a trial of adults with mild-to-moderate COVID-19. VIR-7832 shares the same characteristics as sotrovimab and has been engineered to potentially be a therapeutic T cell vaccine to further help treat and/or prevent COVID-19. Initial safety data are expected in the second half of 2021. Additionally, in July, the U.S. Food and Drug Administration (FDA) cleared the Company’s investigational new drug (IND) application for VIR-7832.
• In May, the European Medicines Agency’s (EMA) CHMP initiated a rolling review of data on sotrovimab that will continue until enough evidence is available to support a formal marketing authorization application (MAA). The rolling review process is expected to be complete in the second half of 2021.
• In May, the EMA’s CHMP issued a positive scientific opinion on sotrovimab for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The CHMP opinion under Article 5(3) can now be considered by the national authorities in EU member states when making evidence-based decisions on the early use of the medicine prior to marketing authorization.
• In May, the FDA granted an Emergency Use Authorization (EUA) to sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Together with GSK, the Company plans to submit a Biologics License Application (BLA) to the FDA in the second half of 2021.
• In June, the Company and GSK announced confirmatory full results for the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p