CureVac Presents Positive Data from mRNA Trials

01.02.2023 - German biotech CureVac has released preliminary data from its ongoing cooperation with UK drugmaker GSK on a new class of “transformative medicines” based on messenger mRNA.

CureVac said the data from the partners’ Phase 1 clinical programs in Covid-19 and seasonal flu vaccine, especially the strong immune responses observed in both indications, “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 and product development in 2023.

In both indications, the new research focuses on older adults and “significantly adds to the validation of our technology platform into this highly relevant and at-risk population,” said CureVac CEO Franz-Werner Haas, who recently announced his impending retirement at the end of the first quarter. He will be succeeded by Alexander Zehnder, who is currently global head of oncology at Sanofi.

In the Covid-19 program, the newly reported immunogenicity data from candidate CV0501 in adults aged around 65 are based on the fully recruited dose groups of 12, 25 and 50 µg, consisting of 10 subjects per dose. CureVac said they show relevant titers of neutralizing antibodies beginning at the lowest tested dose.

While CV0501 encodes the Omicron BA.1 variant, CureVac and GSK plan to start Phase 2 clinical study later this year that will assess monovalent and/or bivalent vaccine candidates designed to target variants seen as clinically relevant.

In the seasonal flu program, the German biotech said a single dose of Flu-SV-mRNA (the dose level was not disclosed) was assessed for safety and reactogenicity in adults aged 60 to 80. It was observed to be safe and well tolerated with no grade 3 adverse events in the 32 trial participants to whom it was administered.

Here, CureVac said immunogenicity was assessed in parallel with a licensed seasonal flu vaccine comparator and elicited antibodies about 2.3 times those produced by the licensed vaccine comparator in the same age group.

The vaccine candidate for future clinical development is expected to target all four flu virus strains currently recommended by the World Health Organiztion (WHO) for influenza vaccines. The partners plan to begin a Phase 1/2 study for this around mid-year.

Author: Dede Williams, Freelance Journalist