Progressing African Bundibugyo Ebolavirus Vaccine Candidate to Clinical Trials
Cairo – Minapharm Group (www.Minapharm.com), a prominent biopharmaceutical company in Africa headquartered in Egypt with branches in Berlin, is set to receive up to US$16.5 million from the Coalition for Epidemic Preparedness Innovations (CEPI).
This funding will propel the development of a vaccine candidate for Bundibugyo ebolavirus, fortifying initiatives aimed at creating vaccines to tackle the swiftest and second-largest Ebola outbreak recorded in the Democratic Republic of the Congo (DRC).
The Bundibugyo vaccine by Minapharm is developed by ProBioGen, a Berlin-based entity within the Minapharm Group, using their proprietary modified vaccinia Ankara (MVA) vaccine platform known as MVA-CR19.
A similar technology underlies a licensed vaccine for smallpox and mpox and has demonstrated long-term immunity in a vaccine targeting the closely related Zaire ebolavirus (source).
CEPI’s investment will facilitate the advancement of the Bundibugyo vaccine candidate through preclinical development and into an early-stage clinical trial to evaluate the vaccine candidate’s immunogenicity and safety.
The human study, identified as a Phase 1 trial, is expected to be conducted in Africa.
Minapharm’s investigational vaccine becomes the fifth Bundibugyo-specific virus vaccine candidate backed by CEPI in response to the growing epidemic.
It is part of a collection of promising CEPI-supported candidates* using various vaccine technologies, aimed at maximizing the potential for developing a safe and effective vaccine that could help mitigate this critical crisis.
It’s the only Bundibugyo vaccine candidate funded by CEPI that aims to provoke both B- and T-cell responses, ensuring comprehensive and durable immunity.
“CEPI’s funding to Minapharm leverages the increasing strength of African-led innovation to confront this worsening outbreak and prepare for future threats,” Dr. Richard Hatchett, CEO of CEPI, commented.
“In just three months, Bundibugyo cases have rapidly spread across the DRC, making this outbreak the largest and deadliest the country has faced.
“We are pleased to support Minapharm’s Bundibugyo vaccine candidate: it will enhance CEPI’s portfolio, provide the world with an additional opportunity for intervention, and advance Minapharm’s proprietary MVA platform, which, if successful, could form the foundation for future African-manufactured filovirus vaccines.
“The quicker we can advance a range of promising candidates, the better our chances of saving lives and controlling this epidemic.”
CEPI aims to bring at least two Bundibugyo vaccines to Emergency Use Authorisation and WHO Prequalification to address this outbreak while also preparing for future Bundibugyo epidemics.
Dr. Wafik Bardissi, Group Chairman and CEO of Minapharm and Chairman of ProBioGen, stated: “For more than 25 years, Minapharm has established robust biologics capabilities in Egypt and, in collaboration with ProBioGen, developed a cross-continental model that merges scientific innovation, proprietary technologies, and advanced biomanufacturing.”
Dr. Bardissi further noted: “This program showcases our strengths throughout the entire biologics continuum, from design and development to manufacturing, in response to a pressing public health emergency.
“With support from CEPI, we are transforming scientific ingenuity into health sovereignty, utilizing the breadth of our technologies and expertise to advance a vaccine response for Africa.”
Dr. Volker Sandig, Chief Scientific Officer of ProBioGen, remarked: “ProBioGen’s MVA-CR19 platform was specifically designed for the rapid generation of recombinant MVA vaccine candidates and scalable manufacturing.”
“We are proud to contribute this platform and our CMC expertise to a Minapharm-led initiative backed by CEPI, facilitating the advancement of a Bundibugyo ebolavirus vaccine candidate towards clinical evaluation in response to an urgent public health requirement.”
Dr. Jean Kaseya, Director General, Africa CDC, emphasized, “The Bundibugyo virus is currently driving the largest Ebola outbreak that the DRC has ever experienced.
“A vaccine candidate developed by an African company is precisely the type of capability our continent needs — not only for this outbreak but also to enable Africa to develop and manufacture the tools required to safeguard its own population.
“We welcome CEPI’s support for Minapharm’s efforts as a significant step towards achieving that health sovereignty.”
In the development of the Bundibugyo-specific vaccine candidate, ProBioGen — Minapharm’s wholly-owned subsidiary based in Germany — will produce the recombinant MVA drug substance under Good Manufacturing Practice (GMP) regulations.
The drug substance is the active component of a vaccine, incorporating viral proteins that can train the immune system to identify and combat a specific pathogen – in this instance, Bundibugyo ebolavirus.
Subsequently, the drug substance will be transported to Minapharm’s facility in Cairo, Egypt, where it will be turned into the drug product – the completed vaccine mixture that combines the drug substance with additional vaccine ingredients and packaging, ready for testing.
Simultaneously, Minapharm intends to transition the drug substance manufacturing to its biotechnology facilities in Cairo, facilitating entirely local production of both drug substance and drug product.
This project builds on more than 25 years of Minapharm’s proven experience in the development, comprehensive manufacturing, and commercialization of complex biologics in Africa.
If the Phase 1 trial of the vaccine candidate proves successful, CEPI expects to collaborate with Minapharm and ProBioGen to support late-stage trials necessary to generate efficacy data for emergency use authorization and licensing.
CEPI, Minapharm, and ProBioGen are committed to ensuring a rapid and affordable supply of the vaccine to affected countries and populations that require it if it is proven safe and effective.
A successful outcome from this project could also establish the groundwork for expanding Minapharm’s vaccine manufacturing capacities in the future, potentially with assistance from CEPI and other collaborators.
So far, CEPI’s Bundibugyo virus vaccine development program has received funding from the European Commission through its 2026 grant under Horizon Europe to CEPI, the U.S. Department of State, and the existing core funding from CEPI.
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