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

• Continued technology platform validation with extended preliminary data from older adults in ongoing Phase 1 studies in COVID-19 and flu
• COVID-19: monovalent modified mRNA construct CV0501 successfully boosted antibody titers against BA.1 and ancestral variants in adults age ≥65
• Flu: monovalent modified mRNA construct Flu-SV-mRNA elicited antibodies approximately 2.3 times those of licensed vaccine comparator in adults aged 60-80
• Reaffirming plan to advance modified mRNA COVID-19 and flu candidates to the next stages of clinical development in collaboration with GSK in 2023

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / January 30, 2023 / CureVac N.V. (Nasdaq:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced positive 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. Detailed data can be reviewed in the associated presentation. 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.

"The exciting preliminary data seen among older adults for our COVID-19 and flu programs significantly add to the validation of our technology platform into this highly relevant and at-risk population," said Franz-Werner Haas, Chief Executive Officer of CureVac. "The strong immune responses we observed in both indications further support our commitment to advancing to the next stage of product development in 2023."

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.

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