News | September 12, 2023

CureVac Advances Seasonal Flu Study To Phase 2 In Collaboration With GSK Following Selection Of Promising mRNA Vaccine Candidate With Broad Coverage

  • Phase 1 part of combined Phase 1/2 study assessed comprehensive series of flu vaccine candidates, featuring up to eight separate mRNA constructs per candidate
  • Best-performing candidate providing broad antigen coverage against WHO-recommended flu strains selected for Phase 2, following positive data from Phase 1 interim analysis
  • Dosing of first Phase 2 participant anticipated in Q4 2023; Phase 2 to include older adults and standard-of-care comparison

CureVac N.V. (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced selection of a promising vaccine candidate for continued clinical development based on positive data from an interim analysis of the ongoing Phase 1 part of a combined Phase 1/2 study, conducted in collaboration with GSK.

The Phase 1 part compared a comprehensive series of multivalent, modified mRNA seasonal flu vaccine candidates with up to eight separate mRNA constructs per candidate, addressing all four WHO-recommended flu strains. The selected vaccine candidate will be advanced to the Phase 2 part of the study, which is expected to dose the first participant in Q4 2023 and will expand to include older adults aged 65 to 85.

“We are very pleased with the interim results from the Phase 1 part of the study, which provided a strong basis to move our clinical development forward into Phase 2,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “The power, flexibility and speed of our mRNA tech­nology platform offers tremendous potential to overcome the current challenges associated with providing seasonally updated and highly effective influenza vaccines. We feel confident that our differen­tiated vaccine candidate has the potential to offer people broad protection and will advance us on the path to transforming public health.”

Vaccine candidates in the Phase 1 part of the combined Phase 1/2 study were tested at different dose levels in 270 healthy younger adults (age 18-50). Interim safety data showed no safety concerns across all tested dose levels for the multi­valent candidates. Immunogenicity of all candidates was assessed in parallel with a licensed seasonal flu vaccine comparator. The humoral responses observed supported the selection of a candidate vaccine for further evaluation in Phase 2 in younger and older adults.

The CureVac-GSK infectious disease collaboration was first announced in July 2020 and focuses on the development of new products based on CureVac’s mRNA technology for different targets in the field of infectious diseases.

Source: CureVac