The drug maker Sanofi Pasteur has been more cautious than some of its rivals in projecting when its Covid-19 vaccines might be ready. Now, it’s announcing an acceleration of clinical trials to reach the market faster — and striking a $425 million deal to broaden its partnership with a smaller biotech company to develop one of them.
The start of a Phase 1/2 clinical trial for a vaccine that Sanofi is developing with GSK has been pushed up to September from December. And a first-in-human study of the vaccine it is developing with Translate Bio, based on mRNA technology, will begin in the fourth quarter, Sanofi said Tuesday.
Sanofi, which has deep experience in vaccinology but has had one of the more conservative timelines of the major players in the race to develop Covid-19 vaccines, is now predicting it will be able to catch up to competitors that got off to an earlier start in clinical trials than it did.
“We are the only vaccine in the race that’s off a proven platform that works in scale,” CEO Paul Hudson said of the vaccine Sanofi is making with GSK’s help.
The vaccine, which Sanofi expects to reach the market sooner than the vaccine it is partnering with Translate Bio on, employs the approach used to make the company’s flu vaccine, Flublok, called a recombinant vaccine. Genetic material from the surface protein of the SARS-CoV-2 virus is inserted into insect cells, which express antigen that is then purified.
The company said its experience working with the recombinant platform will help as it ramps up production.
Sanofi is using one of GSK’s proprietary adjuvants — a compound that boosts the immune response, allowing less vaccine to be used for each person — with this vaccine.
When Sanofi announced it was entering the race to develop Covid-19 vaccines back in mid-February, it estimated it would take three to four years to develop a product. It is now predicting it may be able to win approval for two vaccines in 2021.
“Things have matured a lot from where we were,” John Shiver, senior vice president for global vaccines, said of the compressed timelines.
Sanofi believes it will have enough data from its Phase 1/2 trial for the recombinant vaccine that it could be used via the Food and Drug Agency’s emergency use pathway, if the agency issues such approvals for Covid-19 vaccine. The Phase 3 trial for that vaccine could begin in December or January, Shiver said, with a goal of having the vaccine fully licensed by June.
Sanofi, which like others working on Covid-19 vaccines is producing in bulk at risk — before its candidate vaccines have been shown to work — expects to have 100 million doses of the recombinant vaccine by the end of 2020, and an additional 1 billion doses in 2021, he said.
It’s unclear how many shots will be required to protect each person, though the company expects it may take two, with a four-week interval between the vaccinations. If that proves to be the case — and if the vaccine works — Sanofi could provide enough of this vaccine to protect 50 million people in 2020 and 500 million in 2021.
Translate Bio and Sanofi signed a collaboration deal in 2018 to develop mRNA vaccines for as many as five infectious diseases. The partnership was first expanded in March to pursue the development of an mRNA vaccine against Covid-19. The second expansion, announced Tuesday, essentially gives Sanofi an exclusive license to pursue the development of mRNA vaccines made by Translate Bio across all infectious disease areas.
“This leverages a lot of the great work going on between the two companies. We’ve generated a significant amount of data across some of the initial pathogens we started working on. We felt it was prudent to put this platform to work against infectious disease vaccines more broadly,” said Translate Bio CEO Ron Renaud.
Under terms of the new deal, Sanofi is paying Translate Bio $300 million in cash and will purchase $125 million in company stock at $25.59 per share, representing a 58% premium to Tuesday’s closing price.
Translate Bio will be eligible for up to $1.9 billion in future milestone payments, including payments tied to the development of a Covid-19 vaccine. If any of these mRNA vaccines reach the market, Sanofi will pay Translate Bio royalties based on sales.
Sanofi and Translate Bio have multiple mRNA vaccine candidates against Covid-19 in preclinical testing now, with the goal of selecting a lead candidate for a first-in-human study to start in the fourth quarter. That still puts them behind competing mRNA vaccines from Moderna and a partnership of Pfizer and BioNTech that have already begun clinical trials.
A second mRNA vaccine program against influenza is also in preclinical testing, with a human study expected to start in the middle of 2021.