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Sanofi is expanding a partnership with Translate Bio by paying the Lexington, Massachusetts-based company $425 million to develop messenger RNA (mRNA) vaccines for infectious diseases. The pair’s most advanced program is a vaccine for COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2.
Sanofi began working with Translate in 2018, when it struck a $45 million deal to develop up to five infectious diseases vaccines with Translate’s mRNA expertise. The expanded deal announced today gives Sanofi exclusive rights to develop mRNA vaccines for any infectious disease. Translate will get $300 million in cash and $125 million from stock purchased at a 50% premium. Under the expanded deal, Translate could earn up to $1.9 billion in future payments as well.
While traditional vaccines use whole viruses or viral proteins, mRNA vaccines encode the genetic instructions for making viral proteins in a string of nucleotides, which are packaged in lipid nanoparticles for delivery into human cells.
At the end of March, Sanofi and Translate announced they would develop a vaccine for COVID-19 in which the mRNA encodes the SARS-CoV-2 spike protein.
About a dozen other companies developing mRNA vaccines for COVID-19 are taking a similar approach. In fact, by the time Sanofi and Translate announced their program, another mRNA company, Moderna, had already begun a clinical trial of a COVID-19 vaccine, making it the first company to do so in the US.
And whereas Moderna is gearing up for a Phase III trial of 30,000 people in July, Sanofi and Translate are still evaluating multiple vaccine candidates in animals. They don’t plan on testing the vaccine in humans until the fourth quarter of 2020.
Several of the COVID-19 vaccine frontrunners were designed just days after the first genetic sequences of SARS-CoV-2 were posted online in January. In March, Translate CEO Ron Renaud told C&EN that his company and Sanofi waited to see how SARS-CoV-2 would evolve to help them design a vaccine that the virus couldn’t easily escape. They’ve also been testing multiple versions of the vaccine to see which one is the best. “We wanted to make sure we were methodical with how we approached it,” Renaud said.
In addition to the mRNA vaccine, Sanofi is developing a more traditional COVID-19 vaccine that contains the spike protein itself. That approach, called a recombinant protein subunit vaccine, is already used to make commercial influenza vaccines, including Sanofi’s Flublok vaccine. In contrast, no mRNA vaccine has been proven to prevent disease in humans.
Sanofi plans to start clinical trials of its traditional vaccine in September, a date that was pushed up from an earlier estimate of December. That vaccine could be approved as soon as June 2021, according to the company. The mRNA vaccine, with its later start date, likely wouldn’t be available until the second half of 2021.
Yet regardless of whether Translate’s mRNA vaccine for COVID-19 is ever needed, Sanofi’s investment in the company, and mRNA vaccines, will outlive the pandemic. The pair is planning a clinical trial of an mRNA influenza vaccine in mid-2021. It is also developing mRNA vaccines for other, unnamed viral and bacterial pathogens.