Bundibugyo ebolavirus vaccine candidate advances toward clinical trials
 

(CAIRO) - Egypt-based biopharmaceutical company Minapharm Group, with subsidiaries in Berlin, will receive up to US$16.5 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to support the development of a vaccine candidate targeting Bundibugyo ebolavirus.

The funding will support preclinical development and an early-stage human clinical trial designed to evaluate the candidate’s safety and immunogenicity. The Phase 1 trial is expected to be conducted in Africa.

The vaccine candidate was developed by ProBioGen, a Berlin-based company within the Minapharm Group, using its modified vaccinia Ankara (MVA) vaccine platform, MVA-CR19. The platform relates to the technology used in a licensed smallpox and mpox vaccine. It has also been investigated in a vaccine candidate targeting Zaire ebolavirus, the virus responsible for most Ebola outbreaks.

The CEPI funding makes Minapharm’s candidate the fifth Bundibugyo-specific vaccine candidate to receive support from the organization in response to the ongoing outbreak in the Democratic Republic of the Congo (DRC).

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 said its support for multiple vaccine candidates using different technologies is intended to increase the chances of identifying a safe and effective vaccine against Bundibugyo ebolavirus. The current development program is focused on generating the clinical data needed to assess whether Minapharm’s candidate can advance to later-stage trials.

"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", said Dr. Richard Hatchett, CEO of CEPI. "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."

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."

Dr. Jean Kaseya, Director General, Africa CDC, said, "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."

To develop the Bundibugyo-specific vaccine candidate, ProBioGen will manufacture the recombinant modified vaccinia Ankara (MVA) drug substance in accordance with Good Manufacturing Practice (GMP) standards. The drug substance is the active component of the vaccine. In this case, it contains viral proteins designed to train the immune system to recognize and respond to Bundibugyo ebolavirus, the virus that causes Bundibugyo Ebola disease.

The drug substance will then be shipped to Minapharm’s facility in Cairo, Egypt, where it will be formulated into the drug product—the finished vaccine, combining the active drug substance with other ingredients and prepared for testing.

In parallel, Minapharm plans to transfer drug-substance manufacturing to its biotechnology facilities in Cairo. This would enable the company to manufacture both the drug substance and finished vaccine locally in Egypt.

The project leverages more than 25 years of Minapharm's proven track record and experience in developing, end-to-end manufacturing, and commercializing complex biologics in Africa.

If the Phase 1 trial is successful, CEPI anticipates working with Minapharm and ProBioGen to support late-stage trials that generate the efficacy data needed for emergency use authorization and licensure. If the vaccine is shown to be safe and effective, the organizations intend to support efforts to make it available to affected countries and populations in need.

A successful outcome from the project could also help lay the groundwork for expanding Minapharm’s vaccine manufacturing capabilities in the future, potentially with support from CEPI and other partners.

The Bundibugyo virus vaccine development program is currently supported by funding from the European Commission through CEPI’s 2026 Horizon Europe grant, as well as from the U.S. Department of State and CEPI’s existing core funding.

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