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Vir Biotechnology, Inc.
Preclinical Studies Demonstrate Sotrovimab Retains Activity Against the Full Combination of Mutations in the Spike Protein of the Omicron SARS-CoV-2 Variant
Dec 7 2021
4 min read

Preclinical Studies Demonstrate Sotrovimab Retains Activity Against the Full Combination of Mutations in the Spike Protein of the Omicron SARS-CoV-2 Variant

 – New preclinical findings generated through in vitro testing of sotrovimab againstthe complete pseudo-virus updated to bioRxiv

– Data build on promising signal published last week, underscoring the importance of sotrovimab for early treatment of COVID-19 –

– Sotrovimab is authorized and available for the treatment of early COVID-19 in the US and multiple countries around the world –

LONDON and SAN FRANCISCO, Dec. 07, 2021 (GLOBE NEWSWIRE) --  GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced an update to preclinical data on bioRxiv1, a preprint server, demonstrating that sotrovimab, an investigational monoclonal antibody, retains in vitro activity against the full known Omicron spike protein, the new SARS-CoV-2 variant (B.1.1.529). The preclinical data was generated through pseudo-virus testing of the combined known mutations of the Omicron variant, which included the maximum number of changes (37 mutations) identified to date in the spike protein. These findings build on the initial preclinical data generated through pseudo-virus testing, provided last week, showing sotrovimab retained in vitro activity against key individual mutations of the Omicron variant, including those found in the binding site of sotrovimab. These data add to the growing body of preclinical evidence demonstrating that sotrovimab retains activity against all tested variants of concern.

George Scangos, Ph.D., Chief Executive Officer of Vir, said: “Sotrovimab is the first monoclonal antibody to report preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the still prevalent and highly contagious Delta variant. Given the less than three-fold neutralization shift demonstrated in the pre-clinical pseudo-virus assay, we are confident that sotrovimab will continue to provide significant benefit for the early treatment of patients hoping to avoid the most severe consequences of COVID-19.”

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “From the outset of our collaboration with Vir we hypothesized that sotrovimab would have a high barrier to resistance and thus could deliver best-in-class potential for the early treatment of patients with COVID-19. These pre-clinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date by the WHO, and we look forward to discussing these results with regulatory authorities around the world.”

About sotrovimabSotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor, Inc.’s Xtend™ technology, has also been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

Pre-clinical data, published in bioRxiv, demonstrate that sotrovimab retains activity against all currently tested variants of concern and interest of the SARS-CoV-2 virus as defined by WHO, plus others, including but not limited to Delta (B.1.617.2), Delta Plus (AY.1 or AY.2), Mu (B.1.621) and Omicron (B.1.1.529).

About the sotrovimab clinical development program

  • COMET-ICE: a Phase 3, multi-center, double-blind, placebo-controlled trial investigated an intravenous (IV) infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalized and not requiring oxygen. The final COMET-ICE trial results in the full trial population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p