African Bundibugyo ebolavirus vaccine candidate to be advanced to clinical trials

Leading African biopharmaceutical company Minapharm Group (www.Minapharm.com), 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 (https://apo-opa.co/4xrvZwE).

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 maximize 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 funding to Minapharm harnesses the growing strength of African-led innovation to help confront this increasingly severe outbreak and prepare for future threats. In just three months, cases of Bundibugyo have spread rapidly across the DRC, making this the largest and deadliest outbreak the country has ever faced. We are proud to support Minapharm’s Bundibugyo vaccine candidate: it will round out CEPI’s portfolio, give the world another shot on goal, and advance Minapharm’s proprietary MVA platform, which if successful can serve as the basis for future African-manufactured filovirus vaccines. The faster we can advance a pipeline of promising candidates, the better our chances of saving lives and bringing this epidemic under control.”

Dr Richard Hatchett, CEO, CEPI

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

Dr. Wafik Bardissi, Group Chairman and CEO of Minapharm and Chairman of ProBioGen, said: “For more than 25 years, Minapharm has built proven biologics capabilities in Egypt and, together with ProBioGen, established a cross-continental group model combining scientific innovation, proprietary technologies and advanced biomanufacturing.”

Dr. Bardissi added: “This program demonstrates the strength of our capabilities across the full biologics continuum, from design and development through to manufacturing, in response to an urgent public-health threat. With CEPI’s support, we are turning scientific ingenuity into health sovereignty, drawing on the breadth of our technologies and know-how to advance a vaccine response for Africa.”

“ProBioGen’s MVA-CR19 platform was developed to enable rapid generation of recombinant MVA vaccine candidates and scalable manufacturing,” said Dr Volker Sandig, Chief Scientific Officer of ProBioGen. “We are proud to bring this platform and our CMC expertise to a Minapharm-led program supported by CEPI, helping advance a Bundibugyo ebolavirus vaccine candidate towards clinical evaluation in response to an urgent public-health need.”

Bundibugyo virus is now driving the largest Ebola outbreak DRC has ever faced. A vaccine candidate advanced by an African company is exactly the kind of capability our continent needs - not just for this outbreak, but so that Africa can develop and manufacture the tools it needs to protect its own people. We welcome CEPI's support for Minapharm’s work as a concrete step toward that health sovereignty."

Dr. Jean Kaseya, Director General, Africa CDC

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 commercialization 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 program receives funds from the European Commission through its 2026 grant under Horizon Europe to CEPI, the U.S. Department of State and CEPI's existing core funding.