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Sotrovimab (VIR-7831), an Investigational Antibody Utilizing Xencor's Xtend™ Technology, Receives U.S. FDA Emergency Use Authorization for the Treatment of COVID-19
-- Vir Biotechnology and GlaxoSmithKline's investigational SARS-CoV-2 antibody, engineered with the Xencor XmAb® Fc technology, Xtend™, is authorized for
About this update from Xencor, Inc.
[{"type":"text","content":"\n-- Vir Biotechnology and GlaxoSmithKline's investigational SARS-CoV-2 antibody, engineered with the Xencor XmAb® Fc technology, Xtend™, is authorized for treatment of mild-to-moderate COVID-19 in high-risk adults and pediatric patients --\n\n-- Treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalization or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial –\n\n-- Xencor to receive royalties on worldwide net sales --\n\n MONROVIA, Calif.--(BUSINESS WIRE)--\nXencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for sotrovimab (previously VIR-7831), an XmAb®-engineered antibody developed by Vir Biotechnology, Inc. (Vir) and GlaxoSmithKline plc (GSK). Sotrovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, to treat 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. Xencor has provided Vir non-exclusive licenses to XmAb Fc technologies, including Xtend™, designed to enhance the half-life of novel antibodies being investigated as potential treatments for patients with COVID-19.\n\n\"We are proud that Xtend technology was integrated into sotrovimab for the purpose of reducing the dose administered and potentially enhancing its lung tissue bioavailability and are grateful to Vir and GSK for advancing this important medicine. Xtend has demonstrated, in multiple antibodies and through numerous human clinical trials, the ability to extend antibody drug half-life and reduce dosing frequency in patients, an important feature in anti-viral therapy for pandemic use,\" said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. \"Our partnership with Vir exemplifies our commitment to enabling the broad use of XmAb Fc technologies and to rapidly developing potential treatments for COVID-19 and other serious infectious diseases. Though the vaccine ...