BioNTech and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced a strategic partnership to advance mRNA-based vaccine candidates with the development of BNT166 for the prevention of mpox, an infectious disease that can lead to severe, life-threatening complications. Mpox gained global attention in May 2022 with an increasing number of cases that then developed into an international outbreak. CEPI will provide funding of up to $90 million to support the development of mRNA-based vaccine candidates.

The mpox vaccine program BNT166 is part of BioNTech’s efforts to develop novel prophylactic vaccines for a range of infectious diseases with a high medical need, including indications that are disproportionally prevalent in lower-income countries. Since the eradication of smallpox in 1980, the global population-level immunity against the Orthopoxvirus viral family, including mpox, has been waning. BioNTech is aiming to develop a prophylactic mRNA-based mpox vaccine with a favorable safety profile that can be manufactured at scale.

“Mpox can cause severe complications, particularly in children and pregnant women as well as in immunocompromised individuals. The global outbreak, which was declared a public health emergency of international concern, underlines the need for a highly effective, well-tolerated, and accessible mpox vaccine. We initiated our BNT166 program in May 2022 to help address this need,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We believe our scientific approach as well as our mRNA technology have the potential to significantly contribute to deliver on CEPI’s 100 Days Mission.”

“The 100 Days Mission aims to accelerate the development of a vaccine against a novel virus with pandemic potential to just 100 days, and BioNTech’s world-class scientists, technology and facilities can make a vital contribution. Achieving this mission, and potentially preventing the next pandemic, will require gathering a wealth of knowledge and data about the performance of the latest vaccine platforms, like mRNA, which can enable rapid responses to emerging infectious threats across a broad range of viruses. Our work on mpox could broaden the portfolio of vaccines available against this potentially deadly disease, while building our understanding of how mRNA technology performs against Orthopoxviruses, a family of viruses that have long afflicted humankind and remain an ongoing threat today,” said Richard Hatchett, M.D., Chief Executive Officer of CEPI.

The BNT166 vaccine candidates encode surface antigens that are expressed in the two infectious forms of the monkeypox virus (MPXV) to efficiently fight virus replication and infectivity.