GSK, CureVac hope 2nd time's the charm as updated COVID vax launches into clinic

After barging in late to the COVID-19 vaccine party, GlaxoSmithKline is hoping its shotgun-style approach to developing a jab will pay off, the latest candidate being CureVac’s revised shot that just launched into the clinic. 

That shot—CV2CoV—touted as a “second-generation” mRNA vaccine after CureVac’s first attempt failed, has started to be administered in a phase 1 trial, the two companies announced Wednesday. It comes after a pre-clinical trial in monkeys found that the vaccine elicited an immune response similar to that of natural infection. 

“This phase 1 trial of CV2CoV will provide clinical data to further establish this backbone as a basis to flexibly address not only different COVID-19 variants, but also a range of other diseases and potential combination vaccines,” said Klaus Edvardsen, M.D., Ph.D., chief development officer of CureVac.

The study is recruiting more than 200 adults in the U.S. to determine dosing, with initial data expected in the second half of the year. 

For CureVac, this is a chance at redemption after the biotech was forced to end development of its first shot in October 2021 following less-than-stellar 48% efficacy in clinical trials. GSK had previously agreed to help manufacture 100 million doses of that vaccine back in February 2021, at the same time signing a deal to work on a second shot. 

CureVac, a smaller German biotech, is staking much of its credibility on the development of the vaccine and the partnership with GSK. No other candidate in its platform is past phase 1 studies. 

But for the British big pharma, the CureVac partnership is one of four in the mix to develop a shot—even if the company is late to the game behind peers like Pfizer. GSK is also working with Sanofi, SK Bioscience of South Korea and Canada-based Medicago on candidates. The collaboration with Sanofi is the furthest along, with the two initiating a rolling admission with European regulators in February 2022. 

But GSK and CureVac have familiarity with each other, now approaching two years since initially signing a broader pact for CureVac’s mRNA technology. As a part of that deal, GSK paid more than €270 million ($300 million) in initial funds, including €150 million ($167.5 million) in equity, in exchange for five mRNA-based vaccine and monoclonal antibodies. That original deal didn’t include a COVID shot, which came into the fold six months later, at which point CureVac was still progressing its first COVID vaccine candidate. The two are also collaborating on a flu vaccine using CureVac’s mRNA tech. 

Wednesday's news is welcome for GSK after the FDA announced late last week that it was pausing use of the company’s FDA-approved COVID therapy made in collaboration with Vir Biotechnology, after it was shown to be less effective against the omicron subvariant BA.2. The two companies have said they are preparing a “package of data” to support a higher use of the therapy, sotrovimab, to combat the variant.