Sanofi and Translate Bio Launch Phase 1 Clinical Trial for mRNA-Based Seasonal Influenza Vaccine

On June 22, 2021, Sanofi Pasteur, the global vaccines division of Sanofi, and Translate Bio announced that a Phase 1 clinical trial has been initiated for their jointly developed next-generation mRNA seasonal influenza vaccine. The two companies have developed two vaccine formulations (MRT5400 and MRT5401) utilizing different lipid nanoparticle (LNP) compositions. The trial will evaluate the safety and immunogenicity of these two monovalent candidate vaccines, which encode the hemagglutinin protein of the influenza A/H3N2 virus strain. Interim data from the trial are expected to be announced by the end of this year.

Globally, there are an estimated 290,000 to 650,000 influenza-related deaths annually, with approximately 10 million influenza-related hospitalizations. Influenza seasons predominantly driven by the influenza A (H3N2) virus strain tend to be more severe, particularly among high-risk populations such as older adults and young children. This Phase 1 clinical trial builds upon positive preclinical results announced last November, which demonstrated the promising safety and immunogenicity of the mRNA influenza vaccine. The trial will enroll 280 healthy adults aged 18 to 49 years to receive varying doses of either MRT5400 or MRT5401.

As early as June 2018, the two companies entered into a collaboration and exclusive licensing agreement, combining Sanofi Pasteur's expertise in vaccines with Translate Bio's mRNA R&D expertise to develop mRNA vaccines targeting five infectious disease pathogens. The agreement was initially expanded in March 2020 to include the development of a COVID-19 mRNA vaccine. In June 2020, the two companies further expanded the collaboration agreement to develop a broad portfolio of novel mRNA vaccines for current and future infectious diseases. The collaboration is currently conducting clinical trials for two mRNA vaccines: one targeting COVID-19 and the other targeting influenza.

Note: The original text has been abridged.

References:

[1] Sanofi and Translate Bio Initiate Phase 1 Clinical Trial of mRNA Influenza Vaccine. Retrieved June 22, 2021, from https://www.globenewswire.com/news-release/2021/06/22/2250634/0/en/Sanofi-and-Translate-Bio-Initiate-Phase-1-Clinical-Trial-of-mRNA-Influenza-Vaccine.html

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