SK Bioscience is set to develop and produce a Bundibugyo Ebola virus vaccine in collaboration with global research institutions, backed by U.S. government support. The company aims to establish a large-scale vaccine manufacturing system by leveraging the capabilities of its German subsidiary, IDT Biologika, as part of its strategy to expand its global infectious disease response initiatives.
On Thursday, SK Bioscience announced its participation in a vaccine development project supported by the Biomedical Advanced Research and Development Authority (BARDA), an agency under the U.S. Department of Health and Human Services (HHS). The project will receive up to 99 million USD in funding, with an initial commitment of 36 million USD. These funds will support Phase 1 clinical trials, regulatory compliance, and vaccine production and supply efforts.
The project targets the development of a vaccine to prevent infections caused by the Bundibugyo virus (BDBV), which occurs in Africa. With no currently licensed vaccines or treatments specific to this virus, the participating organizations aim to develop a single-dose vaccine that induces rapid immunity.
IAVI will oversee the entire program, spearheading clinical development and regulatory interactions with bodies such as the U.S. Food and Drug Administration (FDA). The Hilleman Laboratories will handle the production of initial clinical trial vaccines and technology transfer.
SK Bioscience will be responsible for scaling up manufacturing processes and mass production. IDT Biologika will perform tasks from sterile filling to final product manufacturing.
The World Health Organization (WHO) previously identified IAVI’s single-dose Bundibugyo vaccine candidate as promising and recommended priority validation through clinical trials.
This candidate is based on technology developed by researchers at the University of Texas Medical Branch (UTMB) and has demonstrated preventive effects in studies with non-human primates.
In July, the Coalition for Epidemic Preparedness Innovations (CEPI) announced support of up to 8.5 million USD for the Hilleman Laboratories to produce clinical trial quantities of the Bundibugyo vaccine.
During last year’s Sudan Ebola outbreak in Uganda, IAVI provided a recombinant vesicular stomatitis virus (rVSV)-based vaccine candidate for clinical trials of preventive vaccination among contacts.
This project expands on existing vaccine development efforts supported by CEPI, now bolstered by U.S. BARDA funding. The participating institutions plan to accelerate development using the same rVSV platform employed in the already licensed Zaire Ebola vaccine.
Mark Feinberg, President and Chief Executive Officer (CEO) of IAVI, stated that this BARDA funding reflects strong confidence in the vaccine candidate’s potential and the partners’ capabilities, technologies, and commitment. It will significantly enhance the preparedness for future Bundibugyo virus outbreaks.
Jae-yong Ahn, CEO of SK Bioscience, emphasized that this project participation demonstrates the global recognition of SK Bioscience and IDT’s capabilities. He committed to collaborating closely with global partners to ensure rapid vaccine development and a stable supply chain, leading efforts in global infectious disease response.
Meanwhile, SK Bioscience is conducting a global Phase 3 clinical trial for a 21-valent pneumococcal conjugate vaccine in partnership with Sanofi. The company is also advancing the development of an injectable rotavirus vaccine candidate acquired from the U.S. Centers for Disease Control and Prevention (CDC).
