Leading African biopharmaceutical company Minapharm Group, headquartered in Egypt with subsidiaries in Berlin, will receive up to $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.
Meanwhile, Gavi, the Vaccine Alliance, has announced additional funding of $7 million to support Bundibugyo virus disease (BVD) outbreak response.
The money will fund a shipment of 70,000 doses of the Ervebo vaccine to DRC. US$ 6 million from Gavi’s First Response Fund will help countries and partners protect routine immunisation and prepare for future Ebola vaccinations.
Sania Nishtar, the chief executive officer of Gavi, said: “This new funding will help save lives, keep other deadly diseases at bay and support the rollout of the Ervebo vaccine, which has shown promising signs in early data of offering protection against Bundibugyo.”
Nishtar said, “Given the severity of [the Ebola] outbreak, it is important every tool we have is brought to bear to prevent loss of life and ease suffering.”
The additional investment in Ervebo vaccines follows today’s decision by the International Coordination Group on Vaccine Provision (ICG) – which manages the use of Gavi-funded global vaccine stockpiles for outbreak response – to allocate an initial tranche of 70,000 Ervebo doses to DRC.
The proven safety of the Ervebo vaccine, which has been successfully used to fight several Ebola Zaire outbreaks, along with early evidence that it could help reduce severe illness and deaths from BVD, makes it an important tool to potentially save lives in what has now become the largest Ebola outbreak in DRC’s history.
With these vaccines readily available through the stockpile, deployment could happen rapidly, with administration based on guidance from the WHO Strategic Advisory Group of Experts on Immunisation (WHO SAGE).
Also, Gavi will provide US$ 6 million to protect immunisation services and prepare for Ebola vaccination, as part of a wider commitment of up to US$ 50 million through the Gavi First Response Fund made in May.
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.
Richard Hatchett, chief executive officer of CEPI, said:
“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.”
CEPI’s goal is to bring at least two Bundibugyo vaccines to Emergency Use Authorisation and WHO Prequalification to respond to this outbreak, while also building readiness for future Bundibugyo epidemics.
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.”
Bardissi added:
“This programme 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.”
According to Volker Sandig, chief scientific officer of ProBioGen:
“ProBioGen’s MVA-CR19 platform was developed to enable rapid generation of recombinant MVA vaccine candidates and scalable manufacturing. We are proud to bring this platform and our CMC expertise to a Minapharm-led programme supported by CEPI, helping advance a Bundibugyo ebolavirus vaccine candidate towards clinical evaluation in response to an urgent public-health need.”
Meanwhile, Jean Kaseya, director general of Africa Centre for Disease Control (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 — 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 U.S. Department of State and CEPI’s existing core funding.
