BioNTech To Initiate Phase 1/2 Clinical Trial Of MRNA-based Mpox Vaccine Program BNT166

(RTTNews) - 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)

mpox, caused by a member of the Orthopoxvirus viral family, is an infectious disease that can lead to severe, life-threatening complications.

CEPI will provide funding of up to $90 million to support the development of mRNA-based vaccine candidates.

Under the partnership, BioNTech is initiating a Phase 1/2 clinical trial of the mRNA-based mpox vaccine program, BNT166.

The clinical trial (NCT05988203) will evaluate the safety, tolerability, reactogenicity and immunogenicity of two mRNA-based multivalent vaccine candidates for active immunization against mpox.

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).

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.

BioNTech is aiming to develop a prophylactic mRNA-based mpox vaccine with a favorable safety profile that can be manufactured at scale.

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.

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.

This mission is spearheaded by CEPI and embraced by the G7, G20, and industry leaders.

The data generated could contribute to the rapid development of mRNA-based vaccines against future outbreaks caused by Orthopoxviruses.