Celonic will manufacture over 100 million doses of Curevac’s COVID-19 Vaccine Candid...

Celonic will manufacture over 100 million doses of Curevac’s COVID-19 Vaccine Candidate, CVnCoV

Celonic will manufacture over 100 million doses
of Curevac’s COVID-19 Vaccine Candidate, CVnCoV

CureVac  and Celonic Group have conclud a partnership for the production of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020 and CVnCoV is the vaccine candidate chosen for first clinical development. This optimized, non-chemically modified mRNA is encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs). Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. First clinical data reported in November 2020 showed that this candidate was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of the immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. A phase 2b/3 trial, the HERALD study, has now been initiated in December 2020 with a 12µg dose of CVnCoV and  CureVac initiated a rolling submission with the European Medicines Agency (EMA) in February 2021.

More than 50 million doses expected before the end of 2021
Curevac and Celonic have now entered into a commercial supply agreement to produce CureVac’s coronavirus vaccine candidate at Celonic’s state-of-the-art commercial manufacturing facility for biologics and ATMPs, in Heidelberg, Germany. In total Celonic will be prepared to manufacture more than 100 million doses of CVnCoV. More than 50 million doses are expected to be produced before the end of 2021. Under the terms of the initial agreement, technology and knowledge transfer is already underway. The commercial supply agreement includes manufacturing of the mRNA drug substance as well as LNP formulation of the bulk drug product. CureVac reaffirms an expected output capacity of its broad European manufacturing network of up to 300 million doses in 2021. The German biopharmaceutical company has entered into several strategic partnerships for the further development, production and commercialization of CVnCoV, including a collaboration agreement with Bayer in January 2021 with regards to CureVac´s current CVnCoV currently in clinical Phase 2b/3. Last February,  CureVac and GSK also agreed to jointly develop next-generation mRNA vaccines against COVID-19. The development of new vaccine candidates is strengthened by a partnership with the UK Government and its Vaccines Taskforce, which CureVac also entered in February 2021.

Anne-Lise Berthier (30/03/2021)