CEPI will provide up to $16.5 million to Minapharm to advance an experimental Bundibugyo Ebola vaccine through preclinical development and into a Phase 1 clinical trial in Africa.

The funding comes as the Democratic Republic of the Congo faces the largest Ebola outbreak ever reported in the country, with thousands of confirmed Bundibugyo virus cases and more than 2,000 deaths reported by mid-August. WHO says the outbreak remains in a phase of intense transmission.

Bundibugyo virus is a different species from the Zaire ebolavirus responsible for previous major Ebola outbreaks. There is currently no approved vaccine or specific treatment for Bundibugyo virus, making the development of targeted vaccines an urgent public-health priority.

Vaccine to move towards human testing

Minapharm’s vaccine candidate has been developed by ProBioGen, its Berlin-based subsidiary, using the MVA-CR19 modified vaccinia Ankara vaccine platform.

The CEPI funding will support preclinical work and preparation for an early-stage human study designed to assess the vaccine candidate’s safety and immunogenicity. The Phase 1 trial is expected to take place in Africa.

The candidate is designed to generate both B-cell and T-cell immune responses against Bundibugyo virus. CEPI said it is the fifth Bundibugyo-specific vaccine candidate it has supported as part of its response to the outbreak.

CEPI chief executive officer Richard Hatchett 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.”

He added that advancing several vaccine candidates could increase the chances of developing a vaccine capable of helping to control the current epidemic.

Manufacturing could move to Egypt

The programme also has a manufacturing component that could increase Minapharm’s ability to produce vaccines locally.

ProBioGen will initially generate the recombinant MVA drug substance under Good Manufacturing Practice requirements at its German facilities. The drug substance will then be transferred to Minapharm’s facilities in Cairo, where it will be used to manufacture the finished vaccine product.

Minapharm also plans to transfer drug-substance manufacturing to its biotechnology facilities in Cairo. If successful, the move could allow the company to manufacture both the active vaccine material and finished vaccine in Egypt.

Minapharm Group chairman and chief executive officer Wafik Bardissi said: “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.”

The proposed manufacturing transfer could therefore extend the project beyond development of a single vaccine candidate by strengthening local vaccine manufacturing capability.

Phase 1 will test safety and immunity

The candidate is still at the preclinical stage and has not yet been shown to protect people against Bundibugyo virus.

If the Phase 1 study produces positive safety and immunogenicity data, CEPI said it expects to work with Minapharm and ProBioGen on later-stage trials designed to generate efficacy data needed for emergency use authorisation and potential licensure.

ProBioGen chief scientific officer Volker Sandig said: “ProBioGen’s MVA-CR19 platform was developed to enable rapid generation of recombinant MVA vaccine candidates and scalable manufacturing.”

The development programme is taking place against an outbreak that WHO declared a public health emergency of international concern in May. The agency’s latest detailed update reported 4,665 confirmed cases and 2,184 deaths in the DRC as of 12 August, with transmission continuing across six provinces.

CEPI said its broader goal is to advance at least two Bundibugyo vaccine candidates towards emergency use authorisation and WHO prequalification, while building preparedness for future outbreaks.

For Minapharm, the programme could provide a route from African-led vaccine development into clinical testing while also supporting the expansion of vaccine manufacturing capacity in Egypt.