GSK's mRNA Flu Vaccine Promising for All Ages

GSK has announced positive headline results for its mRNA seasonal influenza vaccine, marking a significant milestone as the program now advances into late-stage clinical development.

The Phase 2 study, identified as NCT06431607, has been investigating various dose levels of a modified, multivalent vaccine candidate. The study included 250 healthy adults aged 18 to 64 years and an equal number of healthy older adults aged 65 to 85 years. The vaccine was compared against approved vaccine comparators that are age-appropriate for the participants.

The results from this study indicated that the vaccine formulation elicited strong immune responses against both influenza A and B strains. This was observed in both the younger and older adult groups when compared to the standard care vaccines currently approved for use. Interim data also suggested that the vaccine candidates exhibit an "acceptable safety and reactogenicity profile" across all mRNA formulations tested, as reported by GSK.

Tony Wood, the company's chief scientific officer, commented on the findings, stating, "This marks a significant advancement in our mRNA program and these data support moving into late-stage development. Ultimately, our goal is to develop a new best-in-class vaccine to bring greater protection to people through the influenza season."

The development of this vaccine is based on CureVac's second-generation mRNA backbone. The project has been pursued under an infectious disease vaccines alliance between GSK and CureVac. In July, the partners signed a new licensing agreement, which granted GSK full control over the development and manufacturing of the program as well as other vaccine candidates under their collaboration.

Myriam Mendila, CureVac's chief scientific officer, expressed optimism about the study results. She stated, "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. We are strongly encouraged by the positive response against influenza A strains but particularly excited about adequate immune responses against influenza B."

These promising results were announced shortly after GSK revealed encouraging late-stage results for its "ultra-long-acting" biologic, depemokimab, in severe asthma exacerbations. The SWIFT-1 and SWIFT-2 Phase 3 trials assessed the efficacy and safety of depemokimab in adults and adolescents with severe lung conditions and type 2 inflammation. Both trials met their primary endpoints, showing significant reductions in the annualized rate of clinically significant exacerbations over a 52-week period compared to a placebo.

These sequential successes underline GSK's commitment to advancing innovative treatments and preventative measures in the field of infectious diseases and chronic conditions. The progression of the mRNA influenza vaccine into late-stage development signifies a substantial step toward potentially offering enhanced protection against seasonal flu for various age groups.