Sanofi, GSK Move COVID-19 Vaccine Candidate Into the Clinic, Expect Data by December

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Months after forging a development partnership for a COVID-19 vaccine, GlaxoSmithKline and Sanofi are moving their adjuvanted vaccine candidate into the clinic.

The vaccine candidate, which uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology, will begin a Phase I/II trial in the United States. The trial will include 440 health adults and will be conducted at 11 separate testing sites, the companies announced. The trial will evaluate the safety, tolerability and immunogenicity of the vaccine candidate.

The vaccine candidate uses Sanofi’s S-protein COVID-19 antigen, which is based on recombinant DNA technology to develop the vaccine candidate. That antigen will be boosted by GSK’s pandemic adjuvant technology. The use of an adjuvant may reduce the amount of vaccine protein required per dose, which allows more vaccine doses to be produced and protect more people.

Preclinical data from the vaccine candidate showed an acceptable reactogenicity profile and data based on two injections of the adjuvanted recombinant vaccine showed high levels of neutralizing antibodies that are comparable to levels in humans who recovered from the COVID-19 infection. Pre-clinical results are expected to be published later this year.

First data results from the Phase I/II study are expected to be available by early December. If the data is strong enough, the companies plan to initiate a Phase III study with thousands of patients that same month. GSK and Sanofi said there is a potential for the vaccine candidate to be ready for market within the first half of 2021 should all trials hit their endpoints.

GSK and Sanofi have been laying the groundwork for this moment for the past several months. The two companies have struck deals with the United States and the United Kingdom to supply millions of doses of the vaccine, should it prove to be beneficial. In July, the companies entered into a $2.1 billion deal with the U.S. government for 100 million doses of the vaccine. That funding was expected to cover clinical development costs and also allow the companies to scale up manufacturing and delivery capabilities. Both companies also agreed with the U.K. government to supply up to 60 million doses of recombinant protein-based COVID-19 vaccine. The companies are geared to produce one billion doses of the vaccine in 2021.

Roger Connor, president of GSK Vaccines, said moving the candidate into clinical development is an important moment in addressing the global pandemic caused by the novel coronavirus.

“This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilizes established technology from both companies and can be produced at scale by two of the leading vaccine manufacturers globally. We now look forward to the data from the study, and if positive, beginning a Phase III trial by the end of the year,” Connor said in a statement.

Tomas Triomphe, Global Head of Sanofi Pasteur, also touted the importance of moving their asset into the clinic. The vaccine, he said, could help defeat COVID-19, which has infected more than 26 million people across the globe, including more than 6 million in the United States and nearly 341,000 in the U.K.

“Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December,” Triomphe said.