After 'half-baked' data drop, CureVac releases results on mRNA flu, COVID-19 vaccines in older adults

Weeks after annoying analysts with a “half-baked” data drop, CureVac is back with more clinical trial results on its GSK-partnered mRNA vaccines against influenza and COVID-19. The update fills a key hole in the earlier release by providing an early look at how the vaccines perform in older adults. 

CureVac, a mRNA veteran that largely missed out on the COVID-19 gold rush, responded to the lackluster data on its first vaccine against SARS-CoV-2 by pivoting to a second-generation candidate. The prospect, CV0501, uses modified mRNA, bringing CureVac in line with the practices of its peers, and encodes the BA.1 subvariant of omicron. CureVac is developing the vaccine in parallel to its flu candidate.

In the latest data drop, the German biotech revealed that the 12-µg dose of CV0501 generated a ratio of post-boost to pre-boost serum neutralizing titers against BA.1 of 13.3 at Day 29. The release lacks data on the two higher doses, 25 µg and 50 µg, but CureVac shared some additional figures in a presentation (PDF).

The ratio in the 25-µg arm at Day 29 was 18.4. While CureVac is yet to share Day 29 data on 50 µg, the results at Day 15 suggest it is unlikely to improve on the lower doses. The ratio at Day 15 was lower in the 50-µg cohort than in the 25-µg arm. Against wild-type SARS-CoV-2, the Day 29 ratios for the 12-µg and 25-µg doses were 4.6 and 9.1, respectively.

BA.1 has largely disappeared as other subvariants have emerged, and CureVac is moving with the times. A phase 2 trial that is scheduled to start later this year will assess “monovalent and/or bivalent vaccine candidates designed to target clinically relevant variants,” according to the company.

CureVac is undertaking a similar pivot in flu. The data released Monday come from a study of FLU-SV-mRNA, a H1N1 encoding, monovalent candidate, but the company plans to take a multivalent vaccine into a phase 1/2 trial around the middle of the year. 

In the existing study, the monovalent mRNA vaccine outperformed a licensed quadrivalent product. The study linked FLU-SV-mRNA to a 2.3 times higher level of antibody titers as well as to an increased ratio of post- to pre-boost titers and rate of seroconversion. 

CureVac will face competition from some familiar faces as it moves forward in COVID-19 and flu. The two other biotechs that made the early running in mRNA, BioNTech and Moderna, have captured a big slice of the COVID-19 vaccine market between them and are now moving in on an influenza space dominated by well-entrenched companies with older technologies such as AstraZeneca and Sanofi. 

Shares in CureVac rose 8% to over $12 in premarket trading.