BioNTech to advance mRNA-based mpox vaccine candidates through CEPI deal

18 Sep 2023
VaccinePhase 1mRNAImmunotherapy
BioNTech announced on Monday a partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of mRNA-based vaccine candidates against mpox. CEPI will provide up to $90 million for the company’s BNT166 programme.
In May last year, BioNTech initiated the BNT166 programme to address mpox, which shortly after was declared a public health emergency of international concern by the World Health Organization. The firm’s chief executive Ugur Sahin said "our scientific approach as well as our mRNA technology have the potential to significantly contribute to deliver on CEPI's 100 Days Mission," which aims to accelerate the development of a vaccine against a novel virus with pandemic potential to just 100 days.
Phase I/II trial
BioNTech plans to start a Phase I/II trial of the BNT166 candidates, which encode surface antigens that are expressed in the two infectious forms of the mpox virus to fight replication and infectivity. The study is designed to enrol 196 healthy participants with and without a prior history of smallpox vaccination and will evaluate two mRNA-based multivalent vaccine candidates for active immunisation against mpox.
According to BioNTech, any licensed vaccines developed under the partnership are expected to be made available at affordable prices in low- and middle-income countries. The BNT166 programme also includes the malaria and tuberculosis candidate vaccines BNT165 and BNT164, respectively, which are both currently in Phase I studies.
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