Vir, GSK prepare to submit anti-COVID-19 mAb EUA

By The Science Advisory Board staff writers

Vir Biotechnology and GlaxoSmithKline (GSK) are moving ahead with regulatory submission of their COVID-19 monoclonal antibody (mAb), VIR-7831, after a data monitoring committee said that VIR-7831 worked so well in clinical trials that further study is not necessary to pursue an emergency use authorization (EUA) through the U.S. Food and Drug Administration (FDA).

The recommendation was based on an interim analysis of data from a phase III clinical study of 583 patients enrolled in the COVID-19 Monoclonal antibody Efficacy Trial -- Intent to Care Early (COMET-ICE) trial, which demonstrated an 85% reduction in hospitalization or death in patients receiving VIR-7831 compared to placebo. VIR-7831 was well-tolerated. The trial will continue to follow patients for 24 weeks.

VIR-7831 is an investigational dual-action SARS-CoV-2 mAb that binds to a conserved region of the spike protein. The candidate incorporates Xencor's Xtend technology, 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.

Based on the results, Vir and GSK plan to submit an EUA application to the FDA and for authorization in other countries. The data will also be used to support a biologics license application (BLA) submission to the FDA.

Separately, the companies also announced the publication of data in the preprint server, bioRxiv, demonstrating that VIR-7831 is effective against SARS-CoV-2 variants of concern, based on in vitro data from pseudotyped virus assays.

Copyright © 2021

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