Preclinical data demonstrate sotrovimab, authorised in multiple countries around the world, retains activity against all tested variants of concern, including key mutations of Omicron

Data to be confirmed by further in vitro pseudo-virus testing

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced an update to bioRxiv, a preprint server, with preclinical data demonstrating that sotrovimab, an investigational monoclonal antibody, retains activity against key mutations[1] of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab. These data were generated through pseudo-virus testing of specific individual mutations found in Omicron. To date, sotrovimab has demonstrated ongoing activity against all tested variants of concern and interest defined by the World Health Organization (WHO). The companies are now completing in vitro pseudo-virus testing to confirm the neutralising activity of sotrovimab against the combination of all the Omicron mutations with the intent to provide an update by the end of 2021.

George Scangos, PhD, Chief Executive Officer of Vir, said: 'Sotrovimab was deliberately designed with a mutating virus in mind. By targeting a highly conserved region of the spike protein that is less likely to mutate, we hoped to address both the current SARS-CoV-2 virus and future variants that we expected would be inevitable. This hypothesis has borne out again and again - with its ongoing ability to maintain activity against all tested variants of concern and interest to date, including key mutations found in Omicron, as demonstrated by preclinical data. We have every expectation that this positive trend will continue and are working rapidly to confirm its activity against the full combination sequence of Omicron.'

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: 'Since the beginning of the pandemic, we have been working with Vir to combine our scientific expertise and technologies to deliver an enduring treatment option for patients with COVID-19. Though early, these pre-clinical data support our long-held view on the potential for sotrovimab to maintain its activity as the virus continues to mutate. We are pleased that this treatment option is available to patients in the US and many other countries, and are working to expand access worldwide.'

About sotrovimab

Sotrovimab is an investigational SARS-CoV-2 neutralising 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'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.

Updated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against all current 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 key mutations of Omicron (B.1.1.529).

About the sotrovimab clinical development programme

COMET-ICE: a Phase III, multi-centre, 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 hospitalised 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

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