CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), and Novartis AG announced that they have signed an initial agreement for the manufacturing of CureVac’s COVID-19 vaccine candidate, CVnCoV. Preparations for the start of production, technology transfers and test runs are already underway. Following final agreement, Novartis plans to manufacture the mRNA and bulk drug product of the CVnCoV vaccine candidate for up to 50 million doses by the end of 2021 and up to a further 200 million doses in 2022. Delivery from the manufacturing site in Kundl, Austria, is expected to start in summer 2021.
Dr. Florian von der Mülbe, Chief Production Officer of CureVac, says: “I am very pleased that with Novartis we have found another highly experienced partner to support the production of our vaccine candidate. Together with Novartis we expect to increase significantly our manufacturing capacity and place our production network on an even broader base.”
Steffen Lang, Global Head of Novartis Technical Operations and member of Executive Committee Novartis, adds: “We feel it is our responsibility to do everything in our power to help and we are pleased to announce our collaboration with CureVac. At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. We are currently expanding our site with additional capacities for the production of mRNA in order to best serve the increasing demand.”
CureVac started building an integrated European vaccine manufacturing network with several CDMO partners in the fall of 2020. So far, CureVac is working with Bayer, Fareva, Wacker and Rentschler, among others.
CureVac began development of its mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen first for clinical development, CVnCoV, 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 Nanoparticles (LNPs). Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 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. The quality of immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. In December 2020 CureVac initiated a pivotal Phase 2b/3, the HERALD study, with a 12µg dose of CVnCoV. In February 2021 CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.
CureVac has entered into several strategic partnerships for the further development, production and commercialization of CVnCoV. The company entered into a collaboration agreement with Bayer in January 2021 with regards to CureVac´s current vaccine candidate CVnCoV. In February 2021 CureVac and the British pharmaceutical company GlaxoSmithKline (GSK) agreed to jointly develop next-generation multi-valent 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. GSK will also potentially contribute to this collaboration. Clinical trial and commercial material is provided by the company’s substantial production capacities for mRNA vaccines at its headquarters in Tübingen, supported by the current expansion of manufacturing capacities in Europe, allowing broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the Company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in Tübingen, Germany, and employs more than 600 people at its sites in Tübingen, Frankfurt, and Boston, USA.