Egypt-based biopharma company Minapharm Group is set to receive up to US$16.5 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of a vaccine candidate against Bundibugyo ebolavirus, as efforts intensify to address the ongoing outbreak in the Democratic Republic of the Congo (DRC).

The vaccine candidate has been designed by ProBioGen, Minapharm’s Berlin-based subsidiary, using its proprietary MVA-CR19 modified vaccinia Ankara (MVA) platform. The platform is designed to generate recombinant MVA vaccine candidates and enable scalable manufacturing.

CEPI funding will support the candidate through preclinical development and into a Phase 1 clinical trial, which will evaluate its safety and immunogenicity. The early-stage human trial is expected to be conducted in Africa.

The Minapharm candidate is the fifth Bundibugyo-specific vaccine candidate supported by CEPI. According to CEPI, it is the only candidate in its Bundibugyo portfolio designed to induce both B-cell and T-cell immune responses, with the aim of providing comprehensive and longer-lasting immunity.

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, CEPI. He said the programme would also advance Minapharm’s proprietary MVA platform, potentially supporting the development of future African-manufactured filovirus vaccines.

Dr Wafik Bardissi, Group Chairman and CEO, Minapharm, and Chairman of ProBioGen, said the programme demonstrates the group's capabilities across the biologics value chain, from vaccine design and development to manufacturing.

Under the programme, ProBioGen will initially manufacture the recombinant MVA drug substance under GMP conditions at its German facilities. The material will then be transferred to Minapharm’s Cairo facility for production of the finished vaccine drug product.

Minapharm also plans to transfer drug-substance manufacturing to its biotechnology facilities in Cairo, potentially enabling fully localised manufacturing of both the drug substance and finished vaccine in Egypt.

The project builds on Minapharm’s more than 25 years of experience in developing, manufacturing and commercialising complex biologics in Africa.

Dr Volker Sandig, Chief Scientific Officer, ProBioGen, said the MVA-CR19 platform was developed to facilitate rapid generation of recombinant MVA vaccine candidates and scalable manufacturing, adding that ProBioGen would contribute its platform and CMC expertise to the programme.

The initiative also received support from Africa CDC, with Dr Jean Kaseya, Director General, Africa CDC, highlighting the importance of an African company advancing a vaccine candidate as part of efforts to strengthen the continent's capacity to develop and manufacture vaccines.

If the Phase 1 trial is successful, CEPI expects to work with Minapharm and ProBioGen on late-stage clinical trials to generate efficacy data required for emergency-use authorisation and eventual licensure.

The organisations also intend to establish the capability for rapid and affordable supply of the vaccine to affected countries if the candidate proves safe and effective.