GSK Advances mRNA Flu Vaccine to Late-Stage Clinical Development Following Positive Phase II Results

Positive Phase II Results:
GSK has announced positive headline data from its phase II seasonal influenza mRNA vaccine program, demonstrating improved immune responses against influenza A and B strains compared to the current standard of care in both younger and older adults.

Late-Stage Development:
The positive results support the progression of the mRNA seasonal influenza vaccine program to late-stage clinical development, aiming to develop a new best-in-class vaccine for greater protection during the influenza season.

Safety and Efficacy:
The vaccine candidate showed an acceptable safety and reactogenicity profile, meeting all pre-defined success criteria in the tested age groups.

CureVac Partnership:
The vaccine candidate is based on CureVac’s proprietary second-generation mRNA backbone, and GSK has assumed full control for the development, manufacturing, and commercialization of influenza vaccines through a new licensing agreement.

Clinical Trial Details:
The phase II study assessed the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate in 250 healthy younger adults and 250 healthy older adults.

Future Plans:
GSK aims to advance the program to phase III clinical trials, with the dosing of the first phase III participant associated with a significant milestone payment for CureVac.