US BARDA to provide up to $99M; SK Bioscience partners with IAVI and Hilleman Laboratories
Consortium to develop single-dose vaccine and build supply chain for Bundibugyo Ebola virus
German subsidiary IDT Biologika to handle fill-finish manufacturing in global health security push
SK Bioscience is set to begin developing and manufacturing a vaccine against a novel Ebola virus strain, joining forces with global research institutions backed by large-scale US government funding.
SK Bioscience announced Thursday that it will participate in a vaccine project funded by the Biomedical Advanced Research and Development Authority, known as BARDA, an agency under the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. BARDA will provide up to $99 million for the project, with an initial confirmed grant of $36 million. SK Bioscience joins the effort alongside IAVI, an international nonprofit biomedical research organization, and Hilleman Laboratories.
The project targets the Bundibugyo virus, or BDBV, which has been spreading primarily in the Democratic Republic of the Congo.
As of Sunday, the DRC had recorded a cumulative 10,060 confirmed cases and 4,887 deaths — the second-largest outbreak on record — yet no dedicated vaccine or treatment exists for the disease.
The funding will go toward clinical and regulatory activities including a Phase 1 trial, vaccine production, and the development of updated vaccines based on viral variants. The partners plan to develop a single-dose vaccine designed to generate rapid immunity and establish a supply chain for its distribution.
Within the consortium, IAVI will oversee the overall program, including clinical development and regulatory engagement with the US Food and Drug Administration, while Hilleman Laboratories will handle initial clinical-batch manufacturing and technology transfer. The vaccine will use the same recombinant vesicular stomatitis virus, or rVSV, platform technology as the Zaire Ebola vaccine that has received WHO prequalification, a move intended to accelerate development timelines.
SK Bioscience will lead process scale-up and large-scale manufacturing. The company will work closely with IDT Biologika, its recently acquired German contract development and manufacturing organization subsidiary, to maximize production capacity. IDT will take charge of the fill-finish process — from aseptic filling through to final product — serving as a key node in the global health security supply chain.
Mark Feinberg, president and CEO of IAVI, said the BARDA funding "reflects deep confidence in the promise of the vaccine candidate and in the capabilities, expertise and commitment of our partners." Feinberg added that combining IAVI's accumulated expertise in rVSV vaccine development, clinical work and regulatory affairs with the partners' manufacturing strengths would "dramatically strengthen preparedness against future Bundibugyo virus outbreaks."
Raman Rao, CEO of Hilleman Laboratories, said close collaboration among all participating organizations is essential for vaccine development and production. "Hilleman Laboratories will work with our partners to supply vaccines for clinical trials and pursue technology transfer for large-scale manufacturing, contributing to the development of vaccines that enable rapid response when infectious disease outbreaks occur," Rao said.
Ahn Jae-yong, president of SK Bioscience, said participation in the project demonstrates that the combined capabilities of SK Bioscience and IDT Biologika have earned recognition in the global market. "We will work closely with our global partners to develop vaccines rapidly and build a stable supply chain, taking a leading role in responding to infectious diseases worldwide," Ahn said.
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