Sanofi is joining the array of companies pursuing a COVID-19 vaccine based on messenger RNA (mRNA), an experimental genetic technology intended to coax the body’s cells into producing proteins that treat a disease or spark immunity to one.
Sanofi (NYSE: SNY) announced Friday that it will develop COVID-19 vaccine candidates with Translate Bio (NASDAQ: TBIO), a Lexington, MA-based developer of mRNA therapies. The companies are already partners. In 2018, they began a three-year alliance aiming to develop vaccines for up to five infectious diseases. The COVID 19 research tacks a sixth vaccine target onto that pact.
For Sanofi Pasteur, the vaccines division of Paris-based Sanofi, the new research effort with Translate Bio marks its second COVID-19 vaccine alliance in the past two months. In February, the company announced it is working with the US Biomedical Advanced Research and Development Authority to develop a COVID-19 vaccine. The research will leverage recombinant DNA technology that Sanofi had previously advanced into preclinical development in 2003 when it was researching a SARS vaccine.
For Sanofi’s recombinant DNA vaccine, antigen, which mimics the surface of a virus in order to prompt an immune response, is produced in a bioreactor, Sanofi Pasteur executive vice president of R&D John Shiver said on a Friday conference call. That’s different than Translate Bio’s approach, which uses mRNA—molecules that carry genetic instructions for making proteins—to get cells to make the proteins that prompt the immune response. In short, the body is producing the antigen, Shiver said.
“They both potentially could achieve the same goal,” he said of the two vaccine approaches. “But because we don’t know exactly what’s going to be required for a successful vaccine, this is why it’s good to have so-called more shots on goal.”
Sanofi estimates that a vaccine based on the previous SARS research could reach animal testing this summer, and human testing in the fall, according to David Loew, executive vice president of Sanofi Pasteur. If all goes well, that vaccine could become available to the public in 12 to 18 months. The mRNA vaccine could reach human tests by the end of this year, and potentially become publicly available by the end of next summer.
That timeline puts it well behind Moderna (NASDAQ: MRNA). A Phase 1 study testing the Cambridge, MA-based biotech’s vaccine candidate, mRNA-1273, recently dosed the first patient. The Moderna vaccine is given as two injections into the arm 28 days apart. The company has said it is already making plans for Phase 2 testing.
Other companies that are developing mRNA vaccines for COVID-19 include CureVac and BioNTech (NASDAQ: BNTX), both based in Germany. Last week, BioNTech announced it is collaborating with Pfizer (NYSE: PFE) to develop a COVID-19 vaccine.
Sanofi is betting its partner’s experience with mRNA will translate to COVID-19. Translate Bio has already reached Phase 1 testing with an inhaled drug candidate for cystic fibrosis. Loew said Sanofi believes its partner will be able to quickly assess multiple vaccine candidates. He added that Translate Bio has the capacity to scale up to its manufacturing to hundreds of millions of doses.
“That’s a key differentiation in a pandemic,” Loew said. “You have 7 billion people, that, in theory, need to get vaccinated, so you need hundreds and hundreds of millions of doses if we want to get good coverage around the world.”
But the partners will need to get through clinical testing first. The amended agreement calls for Translate Bio to use its technology to discover, design, and manufacture COVID-19 vaccine candidates. Sanofi will provide its vaccine expertise, including its experience conducting clinical trials globally. According to a Translate Bio securities filing, the partners have agreed to a collaboration budget that covers discovery and preclinical research, though specific financial details were not disclosed.
The amended portion of the collaboration agreement does not come with an upfront or milestone payments to Translate Bio, Loew said. But the partners will negotiate royalties if their research yields a commercialized vaccine. For non-pandemic applications of the research, the milestones and royalties from the 2018 pact apply. That deal paid Translate Bio $45 million up front, and pledged up to $805 million in milestone payments.