Sanofi and Translate Bio Initiate Phase 1 Clinical Trial of mRNA Influenza Vaccine
-- Trial will evaluate potential of next generation of influenza vaccines with combined mRNA technology and flu vaccine development expertise --
-- Positive preclinical safety and immunogenicity data for mRNA influenza vaccine candidates support initiation of Phase 1 clinical trial --
-- Interim data anticipated by the end of 2021; outcomes from this clinical trial will inform next steps of our mRNA-based influenza vaccine program and strategy --
LEXINGTON, Mass., June 22, 2021 (GLOBE NEWSWIRE) -- Sanofi Pasteur, the vaccines global business unit of Sanofi and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, have initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza.
The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. Flu seasons that are dominated by A/H3N2 strain circulation activity tend to be more severe, especially among those considered at-risk such as older adults and younger children.
“The first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of influenza vaccines. We've all witnessed the promise of mRNA technology during this pandemic and are now looking to extend that promise to select annual vaccines,” said Jean-François Toussaint, Global Head of Research and Development, Sanofi Pasteur. “In line with our global leadership and our 70-year history of protecting people with influenza vaccines, we will always focus on developing products that demonstrate protection beyond flu, as we believe it is critical to demonstrate protecting patients from hospitalizations due to cardiovascular events and pneumonia. We look forward to sharing initial results by year-end.”
“We are pleased to have this second mRNA vaccine program underway with our partner Sanofi Pasteur,” said Ronald Renaud, chief executive officer, Translate Bio. “We believe that mRNA technology could have several advantages for a seasonal flu application including the potential ability to demonstrate robust immune responses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity. We look forward to evaluating the potential of these mRNA influenza vaccine candidates in this Phase 1 clinical trial.”
Sanofi and Translate Bio have developed and will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in the Phase 1 influenza mRNA vaccine clinical trial. The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.
The trial follows successful preclinical research which demonstrated promising safety and immunogenicity. Preclinical results were shared previously at the 8th annual mRNA Healthcare Conference in November 2020.
About the Phase 1 trial
About the Sanofi Pasteur and Translate Bio collaboration
This collaboration brings together Sanofi Pasteur’s leadership in vaccines and Translate Bio’s mRNA research and development expertise. Under the agreement, the companies are jointly conducting research and development activities to advance mRNA infectious disease vaccine candidates and mRNA vaccine platform development during a research term of at least four years after the original signing in 2018.
About Translate Bio
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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