An early-stage company based in the U.K. claims to have stabilized SARS-CoV-2 RNA for two months at 45 degrees Celsius. The research, by Stablepharma, in collaboration with University Hospital La Paz in Madrid, Spain, potentially paves the way for thermostable mRNA vaccines.
“It’s difficult to predict timelines,” says Özgür Tuncer, CEO, and executive director of Stablepharma. “But probably by 2022 we will be in a position to know if we can create a thermostable vaccine, and then it depends on a partnership [with a vaccine manufacturer].”
Tuncer spoke to GEN after a Dragon’s Den-style presentation on the company’s StablevaX™ technology at the 18th Annual bioProcessUK 2021 conference earlier this month.
According to Tuncer, Stablepharma is focused on eliminating the cold chain from vaccine manufacturing. The company uses a toolbox of stabilization techniques, including a patented sponge and a sugar glass with high chemical stability.
“What the technology does is stabilize the vaccine in sugar glass and put it into a hibernating state. There are lots of ways to do that, and the technology is quite straightforward,” he explains.
Since February 2021, the company have been working to develop a thermostable mRNA vaccine for COVID-19 in collaboration with the University of Strathclyde.
“We’re manufacturing at an academic scale at the moment,” continues Tuncer. “It’s difficult to predict timelines, but we should have full study output and report from Strathclyde in the next few months.”
Stablepharma then hopes to move into an animal study of antibody response to the reformulated mRNA vaccine. The company is also working on a second, longer established program to develop a fridge-free tetanus diphtheria (Td) vaccine, and has recently announced a collaboration with vaccine manufacturer BB-NCIPD (Bul Bio).
“We’ve conducted animal challenge studies and have fantastic data showing enhanced stability,” says Tuncer. “We still need to do a small first-in-human study and file as a reformulation, but we’re not far from getting to market–it could be fairly quick.”