CureVac Takes Bayer on Board for CVnCoV

08.01.2021 - CureVac has agreed a collaboration with Bayer to speed up production and distribution of its Covid-19 vaccine candidate CVnCOV, which began clinical trials in December with a goal of 36,500 participants in Europe and Asia.

Financial terms of the pan-German agreement, which foresees the further development, supply and key territory operations of the vaccine, have not been disclosed.

The Tübingen-headquartered biotech said the Leverkusen pharmaceutical giant will contribute its expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance as well as support in selected countries.

Terms of the pact establish CureVac as the marketing authorization holder for the vaccine. Bayer will support the manufacturing effort with its operations in the EU and selected additional markets, while holding further options to become marketing authorization holder in markets outside Europe.

 The partners said they hope to be able supply “hundreds of millions of CVnCoV doses around the world” following approval. CureVac hinted earlier that it hopes to submit an application for marketing by mid-2021, pending completion of clinical studies.

Like the Pfizer-BioNTech and Moderna shot, the CureVac candidate is based on an mRNA technology.  However, the company has said it chose to use the potency of untranslated regions to optimize the RNA rather than make chemical modifications.

According to CureVac, its candidate triggers immune responses at a 12-µg dose, compared to the 100 µg used by Moderna. This, it said, will enable it to make more doses.

Commenting on the plans, CureVac CEO Franz-Werner Haas said the cooperation will make CVnCoV available to many people as quickly as possible. Building on the “positive data,” he said, “we now have another strong partner on our side to get the vaccine to the people who need it following the receipt of the requisite regulatory approvals,”

“The need for vaccines against COVID-19 is enormous. We are therefore pleased to be able to provide significant support to CureVac, a leader in mRNA technology, in advancing the further development and supply of its COVID-19 vaccine candidate,” said Stefan Oelrich, president of Bayer’s pharmaceuticals segment.

Match-up of biotechs and “big pharma”

The latest match-up between a young, innovative biotech and an a  pharmaceutical power player resembles the successful expertise meld between Mainz-based BioNTech, which developed the vaccine technology for the candidate branded as Comirnaty, and US drugs mammoth Pfizer.

The CureVac-Bayer deal also supports the German government’s quest to immunize more people and should help to ease the current pressure on its health minister.

 Jens Spahn is facing criticism for Berlin’s agreement to source vaccine supply through the EU rather than build up its own, especially as Germany has two homegrown players and the government owns a 23% share in CureVac . At the same time, smaller European countries leaders, led by the Czech Republic, have praised the cooperative decision as an act of solidarity.

CureVac and BioNTech are also under pressure from Germany’s national and regional governments to license their technology to “big pharma,” toward improving vaccine supply. The intellectual property owners have pushed back against this strategy as impracticable, however, making the current approach appear a compromise.

Both German vaccine developers are working to expand their partner networks for development, production and distribution of vaccines, drawing ingredients from outside firms as well as engaging CDMOs in both production and fill &finish. CureVac is collaborating with Germany’s Wacker and France’s Fareva, among others.

BioNTech is cooperating with German CDMO Rentschler and has pledged to start production at a plant in Marburg, Germany, acquired last year from Novartis as soon as possible.

Author: Dede Williams, Freelance Journalist