Sanofi (SNY) to Start Phase III COVID-19 Vaccine Study Soon
Sanofi SNY and GlaxoSmithKline plc GSK announced that their adjuvanted recombinant protein-based COVID-19 vaccine candidate elicited strong neutralizing antibody responses across all adult groups in a phase II study.
Interim data from the study showed that the adjuvant COVID-19 candidate achieved 95% to 100% seroconversion (generation of antibodies) in all age groups (18 to 95 years old) for all three doses — 5 µg, 10 µg and 15 µg — of the candidate that are being evaluated in the study. Data showed that neutralizing antibodies following immunization with the candidate were comparable to those generated by natural infection.
Moreover, high neutralizing antibody levels were elicited in participants with evidence of prior SARS-CoV-2 infection, after a single dose of the vaccine. The companies stated that this observation suggests strong potential of the candidate to be developed as a booster vaccine for COVID-19.
The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology.
Please note that the phase II study is evaluating two dosing regimens for each doses of the candidate administered 21 days apart for safety, reactogenicity, and immunogenicity.
Based on the promising interim data from the phase II study, the companies plan to initiate a global pivotal phase III study in a few weeks. The late-stage study will evaluate 10µg dose of Sanofi’s recombinant vaccine candidate in combination with Glaxo’s pandemic adjuvant. It will evaluate two formulations of the vaccine candidate targeting the original SARS-CoV-2 (the Wuhan virus) and B.1.351 (South African) variant.
Sanofi and Glaxo anticipate an approval for their candidate in the fourth quarter of 2021, subject to late-stage study data readout and regulatory review.
So far this year, Sanofi’s shares have gained 10.1% compared with the industry’s 6.5% increase.
Please note that the development of the adjuvant vaccine candidate was delayed due to insufficient immune response observed in older adults in early-stage studies likely due to an insufficient concentration of the antigen in the vaccine. Sanofi initiated a new phase II study (the aforementioned study) in February with an improved antigen formulation, with support from the US Biomedical Advanced Research and Development Authority. The improved antigen formulation seems to have improved immunogenicity of the candidate as demonstrated from the interim data from the new study.
Meanwhile, Sanofi has also partnered with Translate Bio TBIO to develop a mRNA-based vaccine candidate, MRT5500, for COVID-19. The candidate is currently being evaluated in a phase I/II study initiated in March this year.
Although development of Sanofi’s adjuvant vaccine was delayed, the company is trying to get engaged in helping a swift recovery of global economy by supporting development of authorized COVID-19 vaccines. In January, Sanofi entered into an agreement with Germany’s BioNTech BNTX to support the manufacture and supply of the latter’s COVID-19 vaccine candidate, which is being co-developed with Pfizer. Meanwhile, Sanofi is also providing manufacturing support for Moderna and J&J’s COVID-19 vaccines.
Sanofi Price
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Zacks Rank
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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