BioNTech SE (BNTX) and the Coalition for Epidemic Preparedness Innovations (CEPI) announced Monday a strategic partnership to advance mRNA-based vaccine candidates with the development of BNT166 for the prevention of mpox (formerly monkeypox)<\/p>\n
mpox, caused by a member of the Orthopoxvirus viral family, is an infectious disease that can lead to severe, life-threatening complications.<\/p>\n
CEPI will provide funding of up to $90 million to support the development of mRNA-based vaccine candidates.<\/p>\n
Under the partnership, BioNTech is initiating a Phase 1\/2 clinical trial of the mRNA-based mpox vaccine program, BNT166.<\/p>\n
The clinical trial (NCT05988203) will evaluate the safety, tolerability, reactogenicity and immunogenicity of two mRNA-based multivalent vaccine candidates for active immunization against mpox.<\/p>\n
The Phase 1\/2 trial aims to enroll 196 healthy participants with and without prior history of known or suspected smallpox vaccination (vaccinia-naive participants).<\/p>\n
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.<\/p>\n
BioNTech is aiming to develop a prophylactic mRNA-based mpox vaccine with a favorable safety profile that can be manufactured at scale.<\/p>\n
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.<\/p>\n
The strategic partnership between BioNTech and CEPI is aiming to contribute to CEPI’s 100 Days Mission, a global goal to accelerate development of well-tolerated and effective vaccines that can be ready for regulatory authorization and manufacturing at scale within 100 days of recognition of a pandemic pathogen.<\/p>\n
This mission is spearheaded by CEPI and embraced by the G7, G20, and industry leaders.<\/p>\n
The data generated could contribute to the rapid development of mRNA-based vaccines against future outbreaks caused by Orthopoxviruses. <\/p>\n