Curevac withdraws MAA of CVnCoV
German CureVac N.V. has withdrawn its application for market approval of its COVID-19 vaccine candidate and will focus on the development of a second-generation vaccine.
CureVac announced that it will focus on a second-generation mRNA vaccine candidate in collaboration with the British pharma major GlaxoSmithKline. Clinical development will start "in the coming months". The company’s first-generation COVID-19 vaccine candidate, CVnCoV, however,will be withdrawn from the ongoing registration process with the European Medicines Agency (EMA) because it would hit the market too late.
A pre-contract for supplies of CVnCoV with the European Commission has been annulled. However, the company needs not to pay back the €450m fee to the EC but have been invested in the establishment of manufacturing capacities that will be used to produce the second generation COVID19 vaccine candidate. A production and commercialisation partnership with Bayer will also be terminated, said Dr. Franz-Werner Haas, CEO of Curevac.
Preclinical results seem to support the great potential of the second-generation mRNA-COVID-19 vaccine candidate, CV2CoV. According to Curevac, CV2CoV demonstrated up to tenfold higher immunogenicity than CVnCoV in animal models. Futhermore, GSK and CureVac will accelerate the development of modified mRNA vaccine constructs. The stock market price initially fell by further 15%,