BioNTech SE (BNTX - Free Report) announced that it will receive a grant of up to 375 million euros ($445 million) from the German Federal Ministry of Education and Research (“BMBF”) to support the development of its mRNA-based coronavirus vaccine program, BNT162, as well as for its potential marketing authorization.
Please note that BioNTech is conducting the vaccine program in collaboration with Fosun Pharma in China and Pfizer (PFE - Free Report) globally except China.
The funding from the BMBF will be received in parts upon achieving certain milestones — preclinical evaluation, initiation and implementation of clinical-stage studies, up scaling of production capacities, and the submission for regulatory approval as well as future marketing authorization of a vaccine. BioNTech stated that it has already achieved five of the eight defined milestones in the funding agreement.
Shares of BioNTech have gained 97.5% so far this year compared with the industry’s increase of 1.3%.
We note that BioNtech is currently evaluating its lead vaccine candidate under the BNT162 program, BNT162b2, in a phase III study in collaboration with Pfizer. The study was initiated in July, following positive result in a phase I study. Data from the phase I study demonstrated that immunization with two 30μg doses of the candidate elicited 3.8 times and 1.6 times SARS-CoV-2–neutralizing geometric mean titers compared to sera of SARS-CoV-2 convalescent patients in younger and in older patients, respectively. The candidate was well tolerated.
Earlier this week, BioNtech and Pfizer submitted an amended protocol to increase enrollment target from 30,000 to 44,000 for their late-stage pivotal study to the FDA for approval.
The coronavirus vaccine candidate under the Pfizer-BioNTech collaboration is one of the leading coronavirus programs that are under development, globally. Other COVID-19 vaccine candidates in late-stage development include AZD1222, being developed under a collaboration between Oxford University and AstraZeneca (AZN - Free Report) , and Moderna’s (MRNA - Free Report) mRNA-1273.
BioNTech is currently evaluating another candidate under the BNT162 program, BNT162b1, in collaboration with Fosun Pharma in a phase I study.
Please note that the, BMBF initiative is supporting development of two other coronavirus vaccine candidates of two other companies. The total funding available under the initiative for the three companies is up to 750 million Euro.
BioNTech currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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