CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today 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.

“Our clinically validated technology platform and second-generation mRNA backbone give us great confidence as we continue clinical development of novel vaccine candidates to address seasonal flu,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “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 us well to develop and deliver seasonal flu vaccines together with GSK that combat dominant strains of the season as they emerge.”

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 licensed flu comparator vaccine.

As previously reported, in 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 favorable tolerability profile and no concerning safety signals. Preliminary immunogenicity data indicated strong hemagglutinin inhibition immune responses in line with a licensed flu comparator vaccine beginning at the lowest tested dose.

The CureVac-GSK infectious disease collaboration was first announced in July 2020 and focuses on the development of new products based on CureVac’s mRNA technology for different targets in the field of infectious diseases.