CVnCoV filed with EU for rolling submission in COVID-19.- CureVac

CureVac N.V. announced initiation of a rolling submission with the European Medicines Agency (EMA) for CVnCoV, the company’s mRNA-based COVID-19 vaccine candidate, currently in late-stage clinical testing. The process was initiated when the first data package consisting of CVnCoV pre-clinical data was submitted to EMA and passed the technical validation. CVnCoV is currently being investigated in a randomized, observer blind, placebo-controlled Phase IIb/III clinical trial called HERALD in healthy adults at a dose of 12 µg at sites in Europe and Latin America.Comment: CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The vaccine is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nano Particles (LNPs). Phase I and IIa clinical trials of CVnCoV began in June and September 2020, respectively. Phase I interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation.