With more than a touch of inevitability, CureVac is abandoning its first mRNA COVID vaccine after dismal results earlier this year and switching focus to a second mRNA asset with GlaxoSmithKline.
A lot was expected from the little German biotech CureVac, with an mRNA shot on its hands, many were hoping the vaccine could match the heights seen by fellow/rival native BioNTech. But a botched first attempt that saw an efficacy range below 50%—far below the original 90% seen in early mRNA readouts from others—has pushed CureVac to finally toss that vaccine out.
Rewind back to June of this year, and preliminary data from CureVac's first-generation mRNA candidate vaccine showed only 47% efficacy at preventing any severity of COVID-19. The news saw CureVac's shares halved at the market.
CureVac dug deep into the data, noting positives in some subgroups and continuing to gun for an approval. But those plans are all now on ice.
“[CureVac] has announced a strategic decision to … withdraw its first-generation COVID-19 vaccine candidate, CVnCoV, from the current approval process with the European Medicines Agency,” the biotech said in a statement Tuesday morning.
CureVac said the agency had talked to the biotech and made it clear that any approval of the shot wouldn’t come until around halfway through next year. The company will now instead focus on "development of second-generation mRNA vaccine candidates in collaboration with GSK,” which will likely be in the latter stages of development by mid-2022.
Reading between the lines, it seems that CureVac may as well hedge its bets on that candidate, CV2CoV, given the weak results seen from the first were likely to never gain market traction, if the shot ever gained approval. It also comes as the more contagious variant, known as Delta, has swept the globe, rendering mRNA vaccines less efficacious in terms of stopping the spread of the virus, though still holding up against severe forms of disease.
The GSK-partnered drug is a different setup from CureVac's first effort and is based on “a different, enhanced mRNA backbone,” GSK has recently said. The companies will now hope to replicate the stronger efficacy seen in animal models in the clinic.
The shot is still some months off clinical development, though the pair believes they can “achieve regulatory approval for market readiness of an improved COVID-19 vaccine in 2022.”
“The decision is also aligned with the evolving dynamics of the pandemic response towards a greater need for differentiated vaccines to address the developing endemic SARS-CoV2 situation,” CureVac added. This has also seen a deal to sell the biotech's first-generation vaccine to Europe canned.
“The global fight against COVID-19 continues, and we remain committed to making a difference with a safe and efficacious vaccine. This goal has not changed, but the requirements to effectively address the virus and emerging variants have changed,” said Franz-Werner Haas, CEO of CureVac.
“In the ongoing transition from acute pandemic to endemic, our decision to withdraw CVnCoV from the regulatory approval process and focus our efforts on second-generation mRNA vaccine candidates reflects expected changes in public health needs that our second generation can potentially address," the CEO continued. “We will now take advantage of CVnCoV learnings and infrastructures to focus our resources on advanced second-generation vaccines in close collaboration with GSK.”
CureVac's shares sagged around 13% to $37.24 in premarket trading Tuesday morning, compared to a close of $43.14.