Bayer is joining CureVac to support its development of the messenger RNA (mRNA)-based COVID-19 vaccine CVnCoV, which advanced last month into a pivotal global Phase IIb/III trial that plans to enroll more than 35,000 patients, the companies said today.
Under the agreement, whose value was not disclosed, Bayer agreed to support the development, supply, and operations of CureVac within “key territory” markets that include the European Union (EU) and unspecified additional countries.
The EU agreed in November to purchase up to 405 million doses of CureVac’s CVnCoV vaccine—an initial 225 million doses, with an option to buy another 180 million—for an undisclosed price.
“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,” Stefan Oelrich, Member of Bayer’s Board of Management and President of Bayer’s Pharmaceuticals Division, said in a statement. “We are highly committed to making our capabilities and networks available to help end this pandemic.”
While CureVac will remain the EU Marketing Authorization Holder for CVnCoV, Bayer agreed to provide services for the vaccine that include clinical operations, regulatory affairs, pharmacovigilance, medical information, and supply chain performance.
Not covered by the agreement is manufacturing of CVnCoV, though Bayer is testing whether it can offer production capacity toward the vaccine, a CureVac spokesman told The Wall Street Journal.
“Several hundred million” doses
The companies said that Bayer’s support services are intended to enable the supply of “several hundred million” doses of CVnCoV worldwide.
CureVac said in November it expected to have capacity to manufacture up to 300 million doses of CVnCoV in 2021 and up to 600 million doses in 2022, after announcing an expansion of its manufacturing network in Europe designed to deliver pandemic-scale volumes of the vaccine through agreements with Wacker, Fareva, and other contract development and manufacturing organization (CDMO) partners.
CureVac is also developing an additional large-scale production facility at its headquarters in Tübingen, Germany, supported by the European Investment Bank (EIB).
“We are very happy to join forces with Bayer, whose expertise and infrastructure will help us make our vaccine candidate CVnCoV even more rapidly available to as many people as possible,” stated CureVac CEO Franz-Werner Haas, LLD, LLM.
CVnCoV is an mRNA-based vaccine encoding the full-length spike protein of SARS-CoV-2 and formulated with lipid nanoparticles (LNP). The vaccine uses nucleotides without chemical modifications in the mRNA, and is designed to provide a strong and balanced activation of the immune system.
CureVac has said that CVnCoV remains stable and within defined analytical specifications for at least three months when stored at a standard refrigerator temperature of 5° C (41° F), and for up to 24 hours at room temperature as a ready-to-use vaccine.
35,000-patient trial
CVnCoV is under study in the Phase IIb/III HERALD trial (NCT04652102), a randomized, observer blind, placebo-controlled study designed to assess the safety and efficacy of the vaccine in adults at a dose of 12 µg. The study is expected to include more than 35,000 participants in Europe and Latin America.
CureVac’s vaccine is one of 28 “Definitely Maybe” candidates among the more than 300 COVID-19 therapeutics included in GEN’s “COVID-19 DRUG & VACCINE CANDIDATE TRACKER.”
CureVac made news in March 2020 when it denied a report in the German newspaper Welt am Sonntag that President Donald Trump’s administration sought to lure German-based CureVac to the U.S. with funding to produce its vaccine exclusively for the American market after then-CEO Dan Menichella visited the White House with other biopharma executives, while Germany’s government pressed for the company to stay in Tübingen and produce its vaccine for Germany and Europe.
Menichella resigned that month, succeeded first by Ingmar Hoerr, a former CEO and founder who took a medical leave of absence, then by Haas.
Also in March 2020, the European Commission offered up to €80 million ($98 million) toward scaling up development and productions of the vaccine. The Coalition for Epidemic Preparedness Innovations (CEPI) awarded the company up to $8.3 million in January 2020 for accelerated vaccine development, manufacturing and clinical tests.
