GSK’s mRNA Flu Vaccine Candidate Moves to Phase III After Positive Phase II Results

GSK’s mRNA Flu Vaccine Candidate Moves to Phase III After Positive Phase II Results

(IN BRIEF) GSK has reported positive results from its phase II trial for an mRNA seasonal influenza vaccine candidate, showing strong immune responses against influenza A and B strains in both younger and older adults. The trial met success criteria for safety and effectiveness, supporting the progression to phase III clinical trials. This development is part of GSK’s ongoing effort to create a next-generation flu vaccine, bolstered by partnerships like the recent licensing agreement with CureVac to enhance its mRNA vaccine development.

(PRESS RELEASE) LONDON, 12-Sep-2024 — /EuropaWire/ — GSK has announced promising phase II trial results for its mRNA seasonal influenza vaccine candidate. The trial, involving both younger and older adults, showed that the vaccine candidates elicited strong immune responses against influenza A and B strains compared to the current standard of care. The vaccine formulations demonstrated an acceptable safety and reactogenicity profile, meeting pre-defined success criteria in both age groups.

These positive results pave the way for GSK to advance the vaccine into phase III clinical trials. Chief Scientific Officer Tony Wood emphasized the importance of this milestone, highlighting the company’s goal to develop a best-in-class flu vaccine for greater protection during the flu season.

GSK’s mRNA platform is part of the company’s broader commitment to innovation, strengthened by partnerships like the recent licensing agreement with CureVac, and investments in technologies such as AI/ML-based sequence optimization and nanoparticle design.

About study NCT06431607

The phase II study assesses the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate, encoding antigens matched to all three WHO-recommended influenza 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 were tested in comparison to an age-appropriate, licensed comparator vaccine.

https://www.clinicaltrials.gov/study/NCT06431607

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024.

Media Contact:

Tim Foley
Vice President, Global Corporate Media Relations
corporate.media@gsk.com
+44 (0)20 8047 5502

SOURCE: GlaxoSmithKline plc