CureVac announces progress in Phase 2 COVID-19, Seasonal Flu programs

CureVac announced solid progress in its clinical vaccine development programs in COVID-19 and seasonal flu, conducted in collaboration with GSK. In the joint COVID-19 development program, recruitment of the ongoing Phase 2 study was completed at 427 randomized participants after the first participant was dosed in August 2023 . The study assesses the safety and immunogenicity of different single booster doses of two modified mRNA COVID-19 vaccine candidates: the monovalent candidate, CV0601, encoding the spike protein of the omicron BA.4-5 variant and the bivalent candidate, CV0701, encoding the spike protein of the omicron BA.4-5 variant as well as the original SARS-CoV-2 strain. Vaccine candidates are compared to a licensed or authorized bivalent COVID-19 comparator vaccine. Interim Phase 2 data are expected in early 2024. In the joint seasonal flu development program, the first participant was dosed in the Phase 2 part of the combined Phase 1/2 study, following selection of a promising vaccine candidate based on positive Phase 1 interim data announced September 12, 2023. The potentially differentiated, multivalent candidate encodes antigens matched to all WHO-recommended flu strains. It was selected from the Phase 1 part of the study that compared a comprehensive series of multivalent, modified mRNA seasonal flu vaccine candidates with up to eight separate mRNA constructs per candidate. In Phase 2, the selected candidate will be tested in younger and older adults at different dose levels compared to age-appropriate licensed seasonal flu comparator vaccines. Data are expected in 2024.