BioNTech intends to advance a prophylactic mRNA-based Mpox vaccine with an encouraging safety profile that can be produced at scale. Credit: Marcus Krauss/Shutterstock.com.

BioNTech has entered a strategic collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop messenger ribonucleic acid (mRNA)-based vaccine candidates for monkeypox (Mpox) prevention.

Under the deal, CEPI will provide funding of up to $90m to support the mRNA-based vaccine development programme BNT166.

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This alliance intends to contribute to the 100 Days Mission of CEPI to expedite the development of well-tolerated vaccines for pandemic viruses arising in the future.

This approach will aid in readying the vaccines for regulatory approvals, as well as production at scale within 100 days of detecting a pathogen.

BNT166 is part of the infectious disease programmes of BioNTech and such vaccine candidates encode for surface antigens expressed in the two infectious Mpox virus types to prevent replication of the virus and infectivity.

BioNTech intends to advance a prophylactic mRNA-based Mpox vaccine possessing an encouraging safety profile that can be produced at scale.

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In this regard, two mRNA-based multivalent Mpox vaccine candidates will be analysed for safety, tolerability, reactogenicity and immunogenicity.

A Phase I/II trial will enrol 196 healthy subjects irrespective of their smallpox immunisation status.

BioNTech CEO and co-founder Ugur Sahin said: “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 programme in May 2022 to help address this need.

“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.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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