Tuesday, May 09, 2023
CureVac announced that the first participant was dosed in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates, developed in collaboration with GSK. The tested multivalent vaccine candidates address all four WHO-recommended flu strains.
The combined Phase 1/2 study will evaluate mRNA-based, modified, multivalent influenza vaccine candidates for safety, reactogenicity and immune responses. The first Phase 1 dose selection part is being conducted in the U.S. and Belgium and will feature a licenced flu comparator vaccine.
The clinically validated technology platform and second-generation mRNA backbone has given great confidence for the development of novel vaccine candidates to address seasonal flu. There are still unmet needs as seasonal flu is ever-evolving and immune responses to current vaccines remain a challenge, particularly in older adults.
The flexibility, speed and scalability of CureVac’s end-to-end mRNA capabilities position well to develop and deliver seasonal flu vaccines together with GSK that combat dominant strains of the season as they emerge.
CureVac and GSK’s ongoing Phase 1 trial in older and younger adults of a monovalent, modified mRNA seasonal flu vaccine candidate, preliminary data showed a favourable tolerability profile and no concerning safety signals. Preliminary immunogenicity data indicated strong haemagglutinin inhibition immune responses in line with a licenced flu comparator vaccine beginning at the lowest tested dose.