BioNTech SE and the Coalition for Epidemic Preparedness Innovations (CEPI) announced a strategic partnership to advance mRNA-based vaccine candidates with the development of BNT166 for the prevention of mpox (formerly monkeypox, caused by a member of the Orthopoxvirus viral family), an infectious disease that can lead to severe, life-threatening complications.
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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.
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 against a potential future pandemic virus so that a vaccine can be ready for regulatory authorization and manufacturing at scale within 100 days of recognition of a pandemic pathogen.
The partnership between BioNTech and CEPI could help accelerate responses to future outbreaks caused by viruses of the Orthopoxvirus viral family in several ways.
For example, advancing the development of an mRNA-based mpox vaccine candidate, if successfully approved and authorized, could help provide larger supplies of vaccines for use against future mpox outbreaks.
In addition, the data generated could contribute to the rapid development of mRNA-based vaccines against future outbreaks caused by Orthopoxviruses.
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 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. ■