The Coalition for Epidemic Preparedness Innovations will provide Minapharm Group with up to $16.5 million to advance a Bundibugyo ebolavirus vaccine candidate through preclinical development and into a Phase 1 clinical trial in Africa.
The funding supports efforts to develop a vaccine response to a Bundibugyo ebolavirus outbreak in the Democratic Republic of the Congo. CEPI said the outbreak has rapidly expanded and is the second-largest Ebola outbreak on record.
Minapharm’s vaccine candidate was designed by Berlin-based ProBioGen, a wholly owned Minapharm subsidiary, using ProBioGen’s proprietary modified vaccinia Ankara vaccine platform, MVA-CR19. The platform is designed to enable rapid generation of recombinant MVA vaccine candidates and scalable manufacturing.
The candidate is intended to induce both B-cell and T-cell immune responses, which CEPI said could support comprehensive and durable immunity. It is the fifth Bundibugyo-specific vaccine candidate receiving CEPI funding in response to the outbreak and the only one in the organization’s portfolio designed to target both types of immune responses.
The planned Phase 1 study will assess the candidate’s safety and immunogenicity in people. If successful, CEPI expects to consider supporting Minapharm and ProBioGen in later-stage trials intended to generate data for emergency-use authorization and licensure.
ProBioGen will manufacture the recombinant MVA drug substance under good manufacturing practice standards in Germany. The drug substance contains viral proteins intended to train the immune system to recognize and fight Bundibugyo ebolavirus.
The material will then be shipped to Minapharm’s Cairo, Egypt, facility, where it will be formulated into finished vaccine product and packaged for testing. Minapharm also plans to transfer drug-substance manufacturing to its biotechnology facilities in Cairo, an effort that could enable local manufacturing of both drug substance and finished vaccine.
CEPI’s goal is to bring at least two Bundibugyo vaccines to emergency-use authorization and World Health Organization prequalification, while improving readiness for future outbreaks.
Minapharm said the program builds on more than 25 years of experience in developing, manufacturing and commercializing complex biologics in Africa. The company said it could also support a future expansion of its vaccine manufacturing capacity.
CEPI, Minapharm and ProBioGen said they intend to enable rapid, affordable vaccine supply to affected countries if the candidate demonstrates acceptable safety and effectiveness.
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