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Sanofi (SNY)/Translate Bio Begin Study on mRNA Flu Vaccine

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Sanofi (SNY - Free Report) and partner Translate Bio (TBIO - Free Report) announced that they have initiated a phase I study which is evaluating their investigational, mRNA-based vaccine candidate against seasonal influenza.

The study, which will be conducted in the United States, will investigate the safety and immunogenicity of the monovalent (single-strain) mRNA-based flu vaccine candidate in up to 280 participants. Initial data from the same is expected by the end of 2021.

The companies will evaluate two formulations of the influenza mRNA vaccine (MRT5400 and MRT5401) in the phase I study. The study will evaluate several dose levels of both vaccine formulations given to healthy adults aged 18 to 49 years.

The companies decided to begin the phase I study on the influenza vaccine candidate after it demonstrated promising safety and immunogenicity results in preclinical studies.

Shares of Sanofi have rallied 7.7% so far this year compared with the industry’s growth of 8%.

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Notably, the study on the influenza vaccine candidate is the second mRNA vaccine program which has been undertaken by Sanofi and Translate Bio.

We remind investors that Sanofi has also partnered with Translate Bio to develop a mRNA-based vaccine candidate, MRT5500, for treating COVID-19 infection. The candidate is currently being evaluated in a phase I/II study which is assessing its safety, immune response and reactogenicity.

Meanwhile, Sanofi is also making an adjuvanted recombinant protein-based COVID-19 vaccine candidate in partnership with Glaxo (GSK - Free Report) . The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology.

Last month, Sanofi/Glaxo began a pivotal phase III study on their adjuvanted recombinant protein-based COVID-19 vaccine candidate.

The phase III study on the COVID-19 vaccine candidate follows the encouraging interim data from a phase II study announced in May 2021, in which the vaccine candidate demonstrated strong neutralizing antibody responses in all adult age groups, with 95 to100% seroconversion rates.

Sanofi and Glaxo anticipate an approval for their vaccine candidate in the fourth quarter of 2021, subject to late-stage study data readout and regulatory review.

Incidentally, Sanofi is lagging in its COVID-19 vaccine development efforts. Pfizer/BioNTech, Moderna (MRNA - Free Report) , AstraZeneca and J&J have already launched their COVID-19 vaccines in several countries and vaccinations are in full swing.

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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