Sanofi (SNY - Free Report) and GlaxoSmithKline (GSK - Free Report) announced that they have initiated a phase I/II study on their adjuvanted coronavirus vaccine candidate. The candidate is being developed using Sanofi’s recombinant protein-based technology and Glaxo’s pandemic adjuvant technology.
The study will evaluate the safety, reactogenicity (tolerability) and immunogenicity of the vaccine candidate in 440 healthy adults. First result from the study, supporting the initiation of a phase III study, is anticipated in December. The late-stage study is also expected to start in the same month. The companies plan to file for regulatory approval in the first half of 2021, subject to sufficiency of data.
Pre-clinical data on the vaccine candidate has demonstrated acceptable tolerability and high levels of neutralizing antibodies that are comparable to levels in patients who have recovered from the COVID-19 infection.
We note that the companies are scaling up manufacturing of the antigen and adjuvant to support their target of producing up to one billion doses of the vaccine in 2021.
Please note that the companies signed a collaboration in April to accelerate the development of a novel vaccine to fight COVID-19. Sanofi will lead the clinical development and registration of the vaccine candidate.
Per the terms of the collaboration, Sanofi will contribute the S-protein COVID-19 antigen developed using its recombinant DNA technology, which has helped produce an exact genetic match to proteins found on the surface of the virus. Glaxo’s adjuvant technology will be used to reduce the amount of vaccine protein required per dose, which, in turn, will support large-scale manufacturing. Proven technologies of these leading companies may lead to a better and scalable coronavirus vaccine, which is the need of the hour.
Shares of Sanofi have gained 0.5% so far this year compared with the industry’s increase of 0.3%.
We note that Sanofi has a collaboration with the Biomedical Advanced Research and Development Authority (“BARDA”) related to the development of coronavirus vaccine. BARDA is funding the development of its recombinant-based COVID-19 vaccine candidate, under the agreement. Meanwhile, the company has also collaborated with Translate Bio (TBIO) to develop an mRNA-based vaccine for coronavirus infection. Leading players in coronavirus vaccine development currently are Moderna, Pfizer/BioNTech and AstraZeneca/Oxford University, having initiated phase III studies on their candidates.
Apart from vaccine, Sanofi was also developing its rheumatoid arthritis drug, Kevzara (sarilumab), as a potential treatment for severe COVID-19 patients. However, the company announced earlier this week that the phase III study evaluating the drug in severely or critically ill patients hospitalized with COVID-19 did not meet the primary endpoint and key secondary endpoint. In July, a Sanofi-led U.S.-based phase III study evaluating Kevzara in critical COVID-19 patients also failed to meet the primary and key secondary endpoints. Sanofi and partner Regeneron (REGN - Free Report) do not plan conduct any further studies on Kevzara in COVID-19
Please note that, currently, Gilead’s (GILD - Free Report) antiviral drug, Veklury (remdisivir) is the only drug to receive emergency use authorization from the FDA for treating severe/critical COVID-19 patients.
Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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