CureVac, GSK announces Phase 2 data from influenza mRNA vaccine program

CureVac (CVAC) announced that GSK (GSK) has reported Phase 2 headline data from the seasonal influenza mRNA vaccine program. The program was fully licensed to GSK under the terms of a licensing agreement announced on July 3, 2024. According to GSK, the data demonstrated positive immune responses against influenza A and B strains compared to the current standard of care, meeting all predefined success criteria in the tested age groups of older and younger adults. The interim data further suggests the tested vaccine candidate has an acceptable safety and reactogenicity profile. The vaccine candidate is based on CureVac’s second-generation mRNA backbone. “The positive Phase 2 results once again highlight the immense potential of our second-generation mRNA backbone to develop best in class vaccines against influenza and other infectious diseases,” said Dr. Myriam Mendila, CSO of CureVac. “We are strongly encouraged by a positive response against influenza A strains but particularly excited about adequate immune responses against influenza B. We look forward to seeing advanced data from the study and potential transition of the program to Phase 3, which would be associated with a significant milestone payment for CureVac.” The Phase 2 study was initiated following interim data reported on April 4, 2024, from the Phase 2 part of the ongoing combined Phase 1/2 study in seasonal influenza. It assesses the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate, encoding antigens matched to all three WHO-recommended flu strains. The study includes 250 healthy younger adults aged 18 to 64 and 250 healthy older adults aged 65 to 85. In each age group, different dose levels will be tested in comparison to an age-appropriate, licensed comparator vaccine.