Pharma Focus Europe

BioNTech and CEPI Announce Collaboration to Advance mRNA Mpox Vaccine Development and Bolster CEPI's '100 Days Mission

Tuesday, September 19, 2023

BioNTech SE (Nasdaq: BNTX) and the Coalition for Epidemic Preparedness Innovations (CEPI) have announced a strategic partnership to advance the development of mRNA-based vaccine candidates, focusing on the creation of BNT166 for the prevention of mpox, formerly known as monkeypox. Monkeypox is an infectious disease that can result in severe, life-threatening complications and gained global attention due to a significant increase in cases in May 2022.

CEPI has committed to providing up to $90 million in funding to support the development of mRNA-based vaccine candidates.

The BNT166 mpox vaccine program is part of BioNTech's broader efforts to develop prophylactic vaccines for infectious diseases with a high medical need, especially those disproportionately affecting lower-income countries. Since the eradication of smallpox in 1980, global population-level immunity against Orthopoxviruses, including mpox, has decreased. BioNTech aims 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 aligns with CEPI's "100 Days Mission," a global initiative to accelerate the development of well-tolerated and effective vaccines against potential pandemic viruses. The mission seeks to have a vaccine ready for regulatory approval and large-scale production within 100 days of identifying a pandemic pathogen, supported by organizations like the G7, G20, and industry leaders. This collaboration between BioNTech and CEPI could contribute to more rapid responses to future outbreaks caused by Orthopoxviruses. Successful approval and authorization of an mRNA-based mpox vaccine candidate could increase vaccine supplies for future mpox outbreaks and aid in the development of mRNA-based vaccines for other Orthopoxviruses.

Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, emphasized the critical need for an effective mpox vaccine, especially for vulnerable populations. He stated that BioNTech's scientific approach and mRNA technology have the potential to support CEPI's 100 Days Mission effectively.

CEPI's CEO, Richard Hatchett, M.D., stressed the importance of collecting data on the performance of vaccine platforms like mRNA to respond swiftly to emerging infectious threats. He explained that the work on mpox could expand the vaccine portfolio against this dangerous disease and advance our understanding of mRNA technology's effectiveness against Orthopoxviruses.

The BNT166 vaccine candidates encode surface antigens found in both infectious forms of the monkeypox virus (MPXV), targeting virus replication and infectivity. A clinical trial (NCT05988203) is planned to assess the safety, tolerability, reactogenicity, and immunogenicity of two mRNA-based multivalent vaccine candidates for active mpox immunization. The Phase 1/2 trial will include 196 healthy participants, both with and without a history of smallpox vaccination.

BNT166 is part of BioNTech's commitment to providing equitable access to effective vaccines for high-need medical indications. This includes ongoing Phase 1 clinical trials for BioNTech's Malaria and Tuberculosis programs (BNT165 and BNT164, respectively). Additionally, BioNTech is establishing a

decentralized manufacturing network in Africa to enable scalable production of mRNA-based medicines, with the first site in Kigali, Rwanda.

BioNTech and CEPI are dedicated to ensuring that any licensed vaccines resulting from this partnership are made available at affordable prices in low- and middle-income countries.

Mpox, formerly known as monkeypox, is a zoonotic infectious disease caused by the monkeypox virus (MPXV), a member of the Orthopoxvirus genus that also includes the variola virus responsible for smallpox. Typical symptoms include skin rash, mucosal lesions, fever, swollen lymph nodes, headache, muscle aches, and sore throat. Severe cases can occur in children, immunocompromised individuals, and pregnant women, leading to complications such as superinfections, pneumonia, sepsis, encephalitis, stillbirth, and vision loss due to corneal infection. Human-to-human transmission can occur through physical contact, contaminated objects, or body fluids, including sexual contact. Although vaccines against Orthopoxviruses are available, there is a pressing need for a broadly accessible mpox vaccine, particularly in endemic regions. BioNTech and CEPI aim to address this need by expanding the vaccine portfolio against this virus through their strategic partnership.

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