BioNTech SE has provided further details on the company’s R&D effort, “Project Lightspeed,” to develop a potential vaccine to induce immunity and prevent COVID-19 infection in response to the growing global health threat posed by the disease. BioNTech’s product candidate, BNT162, is a potential first-in-class mRNA vaccine in the worldwide effort against COVID-19.
 
BioNTech intends to initiate clinical testing for BNT162 in late April 2020, subject to regulatory approval, as part of a global clinical development program in Europe (commencing in Germany), the U.S. and China. The company has been in close contact with regulatory and scientific authorities around the world and is in ongoing discussions with other pharmaceutical companies and research bodies to make a vaccine available to the public as quickly as possible worldwide.
 
As part of its global development program, BioNTech announced a strategic alliance with Fosun Pharma to jointly develop its COVID-19 vaccine in China. In addition, BioNTech is in advanced discussions with its existing collaborator Pfizer regarding the development of the vaccine outside China. BioNTech plans to manufacture the vaccine for clinical trials along with its partner Polymun at BioNTech’s state-of-the-art GMP certified mRNA manufacturing facilities in Europe, and is preparing to ramp up production for global supply in collaboration with its partners.
 
“We feel a duty to exploit our full technology and immunotherapy expertise to help address the COVID-19 pandemic emergency,” said Ugur Sahin, founder and chief executive officer, BioNTech. “We are working closely together with regulatory agencies and our existing collaborators in the infectious disease field, including Pfizer, to rapidly initiate trials in order to make a vaccine available to the public as quickly as possible worldwide. In addition, we are working on a novel therapeutics approach for those patients who have already been infected – we plan to disclose more on that effort in the coming weeks.”