HomeAfrican Bundibugyo ebolavirus vaccine candidate advanced to clinical trials

African Bundibugyo ebolavirus vaccine candidate advanced to clinical trials

Leading African biopharmaceutical company Minapharm Group, headquartered in Egypt with subsidiaries in Berlin, will receive up to US$16.5 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of a Bundibugyo ebolavirus vaccine candidate, strengthening efforts to develop vaccines to combat the fastest-growing and second-largest Ebola outbreak on record affecting the Democratic Republic of the Congo (DRC).

Minapharm’s Bundibugyo vaccine is designed by ProBioGen, a Berlin-based specialist within Minapharm Group, based on their proprietary modified vaccinia Ankara (MVA) vaccine platform, MVA-CR19. A similar technology underpins a licensed vaccine against smallpox and mpox, and has elicited long-term immunity in a vaccine targeting the related Zaire ebolavirus.

CEPI’s funding will advance the Bundibugyo vaccine candidate through preclinical development and into an early-stage clinical trial to assess the immunogenicity and safety of the vaccine candidate. The study in humans, known as a phase 1 trial, is expected to take place in Africa.

Minapharm’s investigational vaccine becomes the fifth Bundibugyo-specific virus vaccine candidate supported by CEPI in response to the escalating epidemic. It joins a portfolio of promising CEPI-backed candidates built on different vaccine technologies to maximise the likelihood of developing a safe and effective shot that could help bring this devastating crisis under control.

It is the only Bundibugyo vaccine candidate CEPI is funding that is designed to induce both B- and T-cell responses for comprehensive and long-lasting immunity.

CEPI’s goal is to bring at least two Bundibugyo vaccines to Emergency Use Authorisation and WHO Prequalification (World Health Organization) to respond to this outbreak, while also building readiness for future Bundibugyo epidemics.

To develop the Bundibugyo-specific vaccine candidate, ProBioGen – a wholly-owned subsidiary of Minapharm based in Germany – will generate the recombinant MVA drug substance under Good Manufacturing Practice (GMP) guidelines. The drug substance is the active component of a vaccine which includes viral proteins that could train the immune system to recognise and fight a specific pathogen – in this case, Bundibugyo ebolavirus. The drug substance will then be shipped to Minapharm’s facility in Cairo, Egypt, to create the drug product – the finished vaccine mixture which combines the drug substance with other vaccine ingredients and packaging ready for testing. In parallel, Minapharm plans to transfer drug substance manufacturing to its biotechnology facilities in Cairo, enabling fully local drug substance and drug product manufacturing.

The project leverages more than 25 years of Minapharm’s proven track record and experience in the development, end-to-end manufacturing and commercialisation of complex biologics in Africa.

If the phase 1 trial of the vaccine candidate is successful, CEPI anticipates working with Minapharm and ProBioGen to support late-stage trials to generate efficacy data for emergency use authorisation and licensure. CEPI, Minapharm and ProBioGen are committed to enabling rapid, affordable supply of the vaccine to affected countries and to the populations that need them should it prove safe and effective.

A positive outcome from this project could also lay the foundation for the future expansion of Minapharm’s vaccine manufacturing capabilities, potentially with support from CEPI and other partners.

To date, CEPI’s Bundibugyo virus vaccine development programme receives funds from the European Commission through its 2026 grant under Horizon Europe to CEPI, the US Department of State and CEPI’s existing core funding.

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