March 12, 2021: “Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
The Companies expect interim results from this trial in the third quarter of 2021.
“Our mRNA vaccine candidate is the result of our expertise in infectious diseases coupled with the innovative technologies of our partner,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.
“Initiating the Phase 1/2 trial represents an important step forward in our goal of bringing another effective vaccine to the ongoing fight against the COVID-19 pandemic.”
“We have made important progress towards developing mRNA vaccine candidates for infectious diseases through our collaboration with our partner Sanofi Pasteur,” said Ronald Renaud, Chief Executive Officer of Translate Bio.
“With the impact of mRNA vaccines demonstrated during the pandemic, our joint development team remains steadfast in our commitment to advancing MRT5500 as part of the collaborative effort to overcome this global health crisis.”
Preclinical studies are ongoing and will continue over the next several months to evaluate whether MRT5500, as well as additional mRNA vaccine candidates, will induce neutralizing antibodies against the emerging SARS-CoV-2 variants, with the potential to inform current and future clinical development.
The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20°C storage temperature for late-stage clinical trials and at launch.
Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C).
MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.
About the Phase 1/2 clinical trial
The Phase 1/2 clinical trial is a randomized, double blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of MRT5500, a COVID-19 vaccine candidate.
A total of 415 healthy adults 18 years of age and older are expected to be enrolled in the trial across 13 investigational sites.
Clinical trial participants will receive one dose of MRT5500, or two doses 21 days apart. Three different dose levels will be investigated (15µg, 45µg or 135µg).
About previously-published preclinical results
Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans.”
https://www.sanofi.com/en/media-room/press-releases/2021/2021-03-12-07-00-00-2191846
