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Sanofi, GSK To Kick Off Human Trials Of Covid-19 Candidate
Corona

Sanofi, GSK To Kick Off Human Trials Of Covid-19 Candidate

French drugmaker Sanofi and GlaxoSmithKline announced the start of the Phase 1/2 human clinical trial for their adjuvanted protein-based COVID-19 vaccine.

Sanofi (SNYNF) and GSK said that the Phase 1/2 clinical trial is a randomised, double blind and placebo-controlled trial tailored to evaluate the safety, tolerability and immune response of the COVID-19 vaccine candidate.

The companies expect first results from the trial in early December this year, which if successful will support the initiation of a Phase 3 trial thereafter. If these data are successful and sufficient for licensure application, Sanofi and GSK (GSK) plan to request regulatory approval in the first half of 2021.  

The vaccine candidate, developed in partnership by Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology.

“The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat COVID-19,” said Thomas Triomphe, Global Head of Sanofi Pasteur. “Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December. Positive data will enable a prompt start of the pivotal phase 3 trial by the end of this year.”

The companies said that a total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the US. Sanofi is leading the clinical development and registration of the COVID-19 vaccine.

Pre-clinical data showed an acceptable reactogenicity profile and data based on two injections of the adjuvanted recombinant vaccine demonstrated high levels of neutralising antibodies that are comparable to levels seen in humans who recovered from the COVID-19 infection. The pre-clinical results will be published later this year, the companies said.

In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to 1 billion doses in 2021. The development of the adjuvanted COVID-19 vaccine candidate is being supported through funding and a collaboration with the US Biomedical Advanced Research and Development Authority (BARDA)

Shares in Sanofi have recovered all of their losses since reaching a low in March and are now trading about 0.2% higher than at the beginning of the year. Looking ahead, the $125.12 average analyst price target reflects 25% upside potential in the shares in the coming 12 months.

The vast majority of Wall Street analysts are bullish on the stock. The Strong Buy consensus boasts 12 Buy ratings versus 2 Hold ratings. (See Sanofi stock analysis on TipRanks)

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