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Sanofi/GSK initiate Phase 1/2 COVID-19 trial, first results expected early December

September 3, 2020

Sanofi (NASDAQ:SNY) and GlaxoSmithKline (NYSE:GSK) have started the Phase 1/2 clinical trial for their COVID-19 adjuvanted recombinant protein-based vaccine candidate.

The trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the COVID-19 vaccine candidate. A total of 440 healthy adults are being enrolled.

First results, anticipated by early December 2020 will support the initiation of a Phase 3 trial in December. If sufficient data is obtained, companies plan to request regulatory approval in H1 2021.

Pre-clinical studies have shown promising safety and immunogenicity and will be published later this year.

In parallel, both the companies are scaling up manufacturing of the antigen and adjuvant with the target of producing up to 1B doses in 2021.

In July 2020, Sanofi/Glaxo joined Operation Warp Speed, to supply 100M COVID-19 vaccine doses to U.S.

The Warp speed participants include Vaxart (NASDAQ:VXRT), Pfizer (NYSE:PFE), Moderna (NASDAQ:MRNA), Merck (NYSE:MRK), Johnson & Johnson (NYSE:JNJ) and AstraZeneca (NYSE:AZN).

Previously: Sanofi plans to start human testing of COVID-19 vaccine – Bloomberg (Aug. 27)

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