CureVac announces data in older adults from COVID-19, flu mRNA vaccines

CureVac announced extended preliminary data from ongoing Phase 1 clinical programs in COVID-19 and seasonal flu conducted in collaboration with GSK. The newly reported data focus on older adult age groups in both indications. The data further support the decision to advance updated versions of the modified mRNA COVID-19 and flu vaccine constructs to the next stage of clinical testing in 2023. COVID-19 Program: Newly reported immunogenicity data from CV0501 in older adults are based on the fully recruited dose groups of 12, 25 and 50microgram, consisting of 10 subjects per dose. They show relevant titers of neutralizing antibodies beginning at the lowest tested dose. On day 29 at the 12microgram dose level, CV0501 generated a ratio of post-boost to pre-boost serum neutralizing titers against BA.1 of 13.3. While CV0501 encodes the Omicron BA.1 variant, a Phase 2 clinical study, expected to start later in 2023, will assess monovalent and/or bivalent vaccine candidates designed to target clinically relevant variants. Seasonal Flu Program: A single dose of Flu-SV-mRNA was assessed for safety and reactogenicity in older adults and was observed to be safe and well tolerated with no grade 3 adverse events in the 32 subjects who were administered the mRNA construct. Immunogenicity of Flu-SV-mRNA was assessed in parallel with a licensed seasonal flu vaccine comparator. Adjusted geometric mean hemagglutinin inhibition antibody titers elicited by Flu-SV-mRNA in older adults were approximately 2.3 times those elicited by the licensed vaccine comparator. In the same age group, the percentage of subjects achieving sero conversion was 89.7% for Flu-SV-mRNA and 56.2% for the licensed flu vaccine comparator. The vaccine candidate for future clinical development is expected to target all four flu virus strains currently recommended by the WHO for influenza vaccines. A Phase 1/2 study for multivalent vaccine candidates is expected to start around mid-2023.