- Sanofi plans to begin clinical testing of its experimental coronavirus vaccine sooner than initially expected, targeting September for the start of a Phase 1/2 study. If all goes well, the first doses could be available for emergency use in January 2021, the French drugmaker said Tuesday.
- The new timeline is an acceleration of several months from what Sanofi set out in April, when it agreed to work with GlaxoSmithKline to develop its vaccine. The companies are using more established technologies than leading developers like Moderna, but have been slower to ready a vaccine for human studies.
- Sanofi is also hedging its bets, allying with Translate Bio, which, like Moderna, specializes in messenger RNA vaccines. On Tuesday, Sanofi deepened its partnership with the Lexington, Massachusetts-based biotech, announcing a deal that will hand Translate $425 million, and potentially much more, in exchange for exclusive global rights to vaccines for infectious diseases.
Despite its vaccine prowess, Sanofi's coronavirus work arguably has received less attention than efforts by Moderna, AstraZeneca and Johnson & Johnson.
On Tuesday, the French drugmaker made the case that, while slower to progress, its lead vaccine candidate has a better chance of proving safe and effective than others quicker to enter clinical testing.
"We're the only vaccine in the race that's off a proven platform that works at scale," said Sanofi CEO Paul Hudson on a call with reporters Monday.
"We're a little bit slower, but we [have] much higher likelihood of success."
Sanofi is using the same technology that underpins its approved influenza vaccine Flublok, a platform that uses insect cells to produce viral proteins capable of triggering a protective immune response in humans. Through its partnership with GSK, the drugmaker is then pairing its protein-based approach with the British pharma's immune-boosting adjuvant.
The companies are confident the resulting vaccine will be more effective in stopping infection or preventing disease than candidates being developed by Moderna and others.
Even so, Sanofi's sped-up timeline reflects the urgency with which companies are moving. A Phase 1/2 study start in September could yield preliminary data by December, with a potential emergency authorization in the U.S. and Europe by January 2021, the company said.
January is the U.S. government's target for beginning vaccinations under 'Operation Warp Speed,' a hyper-aggressive project that's likely to include about seven drugmakers.
Sanofi said it could make up to 100 million doses of its candidate by January, with the potential for one billion doses in 2021.
While the protein-based vaccine is its primary candidate, Sanofi's expanded deal with Translate gives it greater access to the type of messenger RNA technology also used by Moderna. The companies have already been working to evaluate mRNA vaccine candidates in test tubes and animals.
Under the new arrangement, Sanofi will pay Translate $300 million and invest another $150 million in Translate stock in exchange for exclusive global rights to infectious disease vaccines the companies develop.
Translate could receive as much as $1.9 billion in additional milestone payments as well.
The first clinical tests of a coronavirus vaccine candidate are expected in the fourth quarter, Sanofi and Translate said, with earliest approval in the second half of 2021.
If successful, the companies could make between 90 million and 360 million doses of the resulting vaccine each year.