Sanofi doubled down on its original 2018 pact with Translate Bio last year as the pair teamed up for an mRNA approach to COVID vaccines, and today the two announced they are starting clinical trials using the tech.
The phase 1/2 trial, which was originally guided for the fourth quarter 2020 but has slid into Q1, will look to enroll 415 participants using the mRNA vaccine MRT5500, with interim results expected in the third quarter. The trial is set up to assess safety, immune response and reactogenicity, after preclinical data showed “high neutralizing antibody levels.”
Those in the test will either get one dose of MRT5500, or two doses 21 days apart. In all, three different dose levels will be investigated (15µg, 45µg or 135µg). It did not give a breakdown of the percentage of age, gender or race of the trial, simply saying all participants will be over 18 years old.
They’re also working on earlier, preclinical studies to find additional mRNA candidates against emerging SARS-CoV-2 variants, such as those first found in South Africa and Brazil, which may be able to escape some vaccines and natural immunity.
“Our mRNA vaccine candidate is the result of our expertise in infectious diseases coupled with the innovative technologies of our partner,” said Thomas Triomphe, EVP 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.”
Other mRNA vaccines both in trials and in the real world have proven massively effective in stopping severe disease and deaths and appear to also stop transmission of the disease.
This comes a few months after Sanofi and one-time rival, now partner GlaxoSmithKline saw their vaccine efforts hampered by weak results in older adults, forcing them to tweak their approach and delay trials, which has put them further back in a race to vaccinate the world currently being led by mRNA biotechs BioNTech/Pfizer and Moderna, as well as AstraZeneca and Oxford University’s and Johnson & Johnson’s more traditional vaccines.
The pair have however made those tweaks and recently kickstarted a phase 2; and with the mRNA vaccine now in trials, Sanofi is still set up to help in the COVID fight later down the line.
The trial starts after Sanofi last summer doubled down on its 2018 pact with Translate Bio. The original deal saw the pair ink an $805 million pact, worth just $45 million upfront with the rest heavily backloaded, with the companies working together advance to mRNA vaccines under an initial three-year agreement.
But amidst the pandemic, Sanofi paid out substantially more upfront: $300 million in cash and $125 million in an equity investment, with a major $1.9 billion in biobucks also locked into the deal, alongside a new pact penned last March between the pair to work on a vaccine for COVID-19.
Translate Bio transferred technology and processes to allow Sanofi Pasteur to develop and manufacture mRNA vaccines for infectious diseases, and this includes work for MRT5500.