EQS-News

CureVac Announces Positive Data in Older Adults from COVID-19 and Flu mRNA Vaccine Development Programs - Seite 2

COVID-19 Program

Newly reported immunogenicity data from CV0501 in older adults (age ≥65) are based on the fully recruited dose groups of 12, 25 and 50µg, consisting of 10 subjects per dose. They show relevant titers of neutralizing antibodies beginning at the lowest tested dose. On day 29 at the 12µg 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 (dose level undisclosed) was assessed for safety and reactogenicity in older adults (age 60-80) 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 sero­conversion[1]⁾ 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.

Previously discussed preliminary results in younger adults for the COVID-19 and flu programs can be reviewed via the conference call and webcast materials archived on January 6, 2023, on the Events section on the CureVac homepage.

The CureVac/GSK infectious disease collaboration was first announced in July 2020. It focuses on the development of new products based on CureVac’s mRNA technology for different targets in the field of infectious diseases. The collaboration was extended in February 2021 to also include jointly developed vaccine candidates for COVID-19. In 2022, the companies broadened their development strategy to test modified mRNA in addition to unmodified mRNA.