CureVac will shift its manufacturing setup to produce clinical material for second-generation mRNA vaccine candidates as it abandons CVnCoV.
Just one month ago, CureVac dropped two contract development manufacturing organization’s (CDMOs) after demand for mRNA COVID-19 candidate CVnCoV diminished but the firm remained confident future clinical trials would still go ahead.
Now, CureVac has decided to withdraw the first-generation vaccine candidate from the approval process with the European Medicines Agency (EMA) in a bid to “refocus efforts on improved second-generation vaccine candidates we are developing in collaboration with GSK.”
Photo by Jim Wilson on Unsplash
According to the firm, its second-generation candidates are based on an improved mRNA setup and includes flu candidates, infectious disease indications with GSK, and COVID-19 program, CV2CoV, which is anticipated to enter late-stage clinical development by mid-2022.
As such, CureVac told us it will shift its manufacturing setup at its European network plants to produce clinical materials for its second-generation candidates.
“Additionally, we are assessing the possibility of using existing materials for the development and production of second-generation vaccine candidates, as we manage commitments to our raw material suppliers,” said CureVac.
The company is also reviewing arrangements with third parties and plans to refine decisions in the coming months.
No repayments needed
As a direct result of withdrawing its EMA application, the existing Advanced Purchase Agreement with the European Commission will be ceased.
“We had secured an upfront payment of €450 million ($520 million) through the Advanced Purchase Agreement with the European Commission – as of now, we have spent more than €450 million developing CVnCoV and do not expect to make any repayments to the EU,” said CureVac.
The firm also received a €252 million ($291 million) grant from the German Federal Ministry of Education and Research. However, its decision to terminate CVnCoV’s EMA application means CureVac we will not be able to claim more than €196 million.
CureVac says it is assessing the possibility of using CVnCoV commitments for the second-generation vaccine candidates and admits “while there will be write-offs,” it wants to maximize the reuse of existing pledges.
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