CureVac and Celonic have entered a commercial supply agreement to manufacture over 100 million doses of the former’s mRNA-based Covid-19 vaccine candidate CVnCoV.
As an optimised, non-chemically modified mRNA, CVnCoV encodes the prefusion stabilised full-length spike protein of the SARS-CoV-2 and is formulated within lipid nanoparticles.
The vaccine candidate will be produced at Celonic’s commercial manufacturing facility for biologics and advanced therapy medicinal products in Heidelberg, Germany.
The companies intend to produce over 50 million doses of CVnCoV before the end of this year.
According to the initial agreement, technology and knowledge transfer are progressing.
The manufacturing of the mRNA drug substance and the LNP formulation of the bulk drug product are included in the commercial supply agreement.
CureVac confirmed a potential output capacity of its extensive European manufacturing network of up to 300 million doses this year.
CureVac chief production officer Dr Florian von der Mülbe said: “The manufacturing of sufficient quantities of vaccine is critical to combating the Covid-19 pandemic.
“With this partnership, we are further extending our integrated European manufacturing network, reinforcing the overall production capacity for our Covid-19 vaccine candidate CVnCoV.”
According to phase I interim data, CVnCoV was generally well tolerated across all tested doses and prompted robust antibody responses apart from showing signs of T cell activation.
The quality of the immune response was similar to recovered Covid-19 patients, imitating the immune response after a natural infection.
CureVac commenced a phase IIb/III HERALD study of a 12µg dose of CVnCoV last December and began a rolling submission with the European Medicines Agency (EMA) for the vaccine candidate last month.
Celonic CEO Dr Konstantin Matentzoglu said: “We have invested heavily to support our partners in bringing novel Covid-19 therapeutics and vaccines to patients at an accelerated pace.”
Earlier this month, Novartis entered an initial agreement with CureVac to manufacture the mRNA and bulk drug product for CVnCoV.