The Coalition for Epidemic Preparedness Innovations (CEPI) says it will provide up to $16.5 million to Minapharm Group to advance a Bundibugyo ebolavirus vaccine candidate into clinical trials.
CEPI said this in a statement on Thursday, noting that the funding was aimed at strengthening efforts to develop vaccines against Ebola.
It said the vaccines were intended to combat the fastest-growing and second-largest Ebola outbreak on record, affecting the Democratic Republic of the Congo (DRC).
It said Minapharm Group, headquartered in Egypt with subsidiaries in Berlin, would develop the candidate with Berlin-based ProBioGen, using its proprietary modified vaccinia Ankara vaccine platform, MVA-CR19.
According to the statement, CEPI’s goal was to advance at least two Bundibugyo vaccines to Emergency Use Authorisation and World Health Organization prequalification for the current outbreak, while building readiness for future epidemics.
“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 One trial, is expected to take place in Africa.
“Minapharm’s investigational vaccine becomes the fifth Bundibugyo-specific virus vaccine candidate supported by CEPI in response to the escalating epidemic,” CEPI said.
The Chief Executive Officer of CEPI, Dr Richard Hatchett, said the investment would harness growing African-led innovation to confront the outbreak and strengthen preparedness for future health threats.
He said Bundibugyo cases had spread rapidly across the DRC within three months, making it the largest and deadliest Ebola outbreak the country had ever faced.
“We are proud to support Minapharm’s Bundibugyo vaccine candidate: it will round out CEPI’s portfolio and give the world another shot on goal,” he said.
Hatchett added that the programme could advance Minapharm’s proprietary MVA platform, which, if successful, could serve as a basis for future African-manufactured filovirus vaccines.
Dr Wafik Bardissi, Group Chairman and Chief Executive Officer of Minapharm and Chairman of ProBioGen, said the programme demonstrated the company’s capabilities across the biologics development and manufacturing continuum.
“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,” Bardissi said.
The Chief Scientific Officer of ProBioGen, Dr Volker Sandig, said its MVA-CR19 platform was developed to enable rapid generation of recombinant 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,” Sandig said.
Dr Jean Kaseya, Director-General of the Africa Centres for Disease Control and Prevention (Africa CDC), said the development demonstrated Africa’s growing capacity to advance vaccine candidates.
He said an African company developing the vaccine showed the capability needed for the continent to develop and manufacture tools to protect its people.
“Not just for this outbreak, but so that Africa can develop and manufacture the tools it needs to protect its own people,” Kaseya said.
The statement said that under the project, ProBioGen would generate the recombinant MVA drug substance under Good Manufacturing Practice guidelines before shipping it to Minapharm’s facility in Cairo for formulation and packaging.
Minapharm also plans to transfer drug substance manufacturing to its biotechnology facilities in Cairo, enabling local manufacture of both the drug substance and finished vaccine product.
CEPI said that if the Phase One trial proved successful, it anticipated working with Minapharm and ProBioGen to support late-stage trials and generate efficacy data for emergency authorisation and licensure.
The organisations are also committed to enabling rapid and affordable vaccine supply to affected countries and populations if the candidate proves safe and effective, the statement said.
CEPI said its funding was awarded to Minapharm following the company’s application to its Call for Proposals seeking developers to advance Bundibugyo vaccine candidates.
