German biotechnology company BioNTech and the Coalition for Epidemic Preparedness Innovations (CEPI) have joined forces to advance the mRNA-based vaccine candidates.
Under the partnership, CEPI will provide up to $90m in funding to support the development of mRNA-based vaccine candidates.
The partnership will advance the development of BNT166 for the prevention of mpox (monkeypox), an infectious disease caused by the Orthopoxvirus family viruses.
BioNTech’s BNT166 vaccine programme includes novel prophylactic vaccines for a range of infectious diseases, including those prevalent in lower-income countries.
The strategic partnership also contributes to CEPI’s 100 Days Mission, which aims to advance the development of well-tolerated vaccines against potential future pandemics.
It will help create a vaccine that can be ready for regulatory authorisation and manufacturing at scale within 100 days of recognition of a pandemic pathogen.
CEPI CEO Richard Hatchett said: “The 100 Days Mission aims to accelerate the development of a vaccine against a novel virus with pandemic potential to just 100 days, and BioNTech’s world-class scientists, technology and facilities can make a vital contribution.
“Achieving this mission, and potentially preventing the next pandemic, will require gathering a wealth of knowledge and data about the performance of the latest vaccine platforms, like mRNA, which can enable rapid responses to emerging infectious threats across a broad range of viruses.
“Our work on mpox could broaden the portfolio of vaccines available against this potentially deadly disease, while building our understanding of how mRNA technology performs against Orthopoxviruses, a family of viruses that have long afflicted humankind and remain an ongoing threat today.”
The partnership between BioNTech and CEPI will advance the responses to future outbreaks caused by viruses of the Orthopoxvirus viral family in several ways.
It will support the development of an mRNA-based mpox vaccine candidate, which could help provide large supplies of vaccines for use against future mpox outbreaks.
In addition, the data generated could support the rapid development of mRNA-based vaccines against future outbreaks caused by Orthopoxviruses.
A Phase 1/2 clinical trial will evaluate the safety, tolerability, reactogenicity and immunogenicity of two mRNA-based multivalent vaccine candidates for active immunisation against mpox.
Furthermore, BioNTech aims to establish a decentralised end-to-end manufacturing network in Africa, to enable scalable production of mRNA-based medicines.
The German biotech company is currently building the first manufacturing site, based on its advanced BioNTainer solution, in Kigali, Rwanda.
BioNTech co-founder and CEO Ugur Sahin said: “Mpox can cause severe complications, particularly in children and pregnant women as well as in immunocompromised individuals.
“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 program 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.”
