- French drugmaker Sanofi will begin development of a vaccine against the new coronavirus that's rapidly spread across China, announcing Tuesday a partnership with the U.S. government that will build on work the company's done investigating a treatment for the related SARS virus.
- Sanofi is the third major biopharmaceutical company to partner with the Biomedical Advanced Research and Development Authority, or BARDA, following announcements in recent weeks from Regeneron and Johnson & Johnson. Regeneron is working on antibody-based treatments, rather than a vaccine.
- The French pharma thinks it can move quickly, based on its past work in SARS and the applicability of technology that it uses for its quadrivalent influenza vaccine. David Loew, Sanofi's head of vaccines, said the company expects to have a research candidate ready for in vitro testing within six months and for clinical study within a year and a half.
As the coronavirus outbreak swept through China's Hubei province in December and January, Sanofi, along with other major vaccine makers like GlaxoSmithKline, Merck & Co. and Pfizer, held back from joining the wave of smaller biotechs announcing vaccine development programs.
With their experience and manufacturing capabilities, larger drugmakers are critical partners in producing vaccines against fast-moving and deadly viruses. In fighting past epidemics of Ebola and Zika, for example, Merck & Co, Johnson & Johnson and Sanofi started clinical testing that, in the case of Ebola virus, resulted in the world's first authorized vaccine against the pathogen.
But developing vaccines is costly and comes with substantial risk: epidemics can burn out, making years-long studies difficult, while producing a candidate at scale takes substantial investment in manufacturing. Sanofi dropped its Zika vaccine efforts after BARDA decided against funding a late-stage trial needed to prove the company's candidate worked, STAT previously reported.
In monitoring the coronavirus outbreak, the tipping point for Sanofi executives came when infections continued to spread despite the drastic efforts taken by the Chinese government to lock down Wuhan and other nearby cities.
"When we saw that the Chinese government took these radical measures and the epidemic actually continued to increase, that gave us pause and we felt that it's a different category than what we have seen with Zika," said Sanofi's Loew on a conference call with reporters.
"The measures that have been taken, to my knowledge, are probably the most aggressive we have ever seen to tackle a spreading disease."
Despite China's efforts to contain transmission, more than 70,000 people have been infected in the country and nearly 1,800 have died from the disease now known as COVID-19. The virus, which is genetically similar to both SARS and MERS, has spread from China to 25 other countries, infecting 794 outside of China as of Feb. 17, according to figures from the World Health Organization.
With the world's focus on the virus, scientists have raced to publish initial epidemiological findings and to better characterize how likely people are to experience the severe and sometimes fatal symptoms that can result from infection.
Still, researchers remain uncertain how contagious the virus is during an incubation period that's thought to last as long as two weeks, and whether the numbers released by the Chinese government reflect the true scale of the outbreak.
"We don't know if the virus is suddenly going to disappear, or if it's going to accelerate," said Loew. "There's a lot of insecurity for industry and I think therefore industry can't carry alone all the risks."
Collaborative partnerships like the one Sanofi struck with BARDA, therefore, are critical, according to the executive.
Financial details weren't disclosed, but BARDA said it would "provide expertise and reallocated funds to support the vaccine's development."
To produce a vaccine candidate, Sanofi will use recombinant DNA technology that currently underpins the approved quadrivalent influenza vaccine FluBlok, which the pharma acquired in a 2017 deal to buy the Meriden, Connecticut-based Protein Sciences.
Protein Sciences had also begun work on a SARS vaccine candidate using the same platform, advancing research to late preclinical stages. That candidate was aimed at a "spike" protein found on the surface of the SARS virus and, researchers think, the novel coronavirus from China as well.
Sanofi plans to combine the DNA sequence that encodes for this spike protein with DNA of a baculovirus that's harmless to humans.
If all goes well, a vaccine candidate could be ready for in vitro testing within six months, Loew said, with clinical testing to begin six months to a year following that achievement.
Phase 1 testing to establish safety and the vaccine's ability to provoke an immune response would follow, and then larger tests to prove the vaccine could actually block infections.
Citing the industry's experience with Ebola, John Shiver, Sanofi's head of vaccine R&D, said three or four years would probably be the fastest the company could get to a licensed vaccine.
But Sanofi executives cautioned against putting too much certainty into development timelines.
"We are in uncharted territory," said Loew. "We need to be careful on what we assume because it's a bit of a fluctuating situation right now in terms of the epidemiological burden, the death rates and what might happen seasonally."