African-Made Ebola Vaccine Candidate to Advance to Clinical Trials After US$16.5mn Funding

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, the biopharmaceutical company said in a statement on Friday.

• 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.
• Minapharm’s investigational vaccine becomes the fifth Bundibugyo-specific virus vaccine candidate supported by CEPI in response to the escalating epidemic.

"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, said.

It joins a portfolio of promising CEPI-backed candidates* built on different technologies to maximise the likelihood of developing a safe and effective vaccine. Minapharm's 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.

"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 of CEPI, said.

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.

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.