SK Bioscience joins $99m BDBV vaccine development project

SK Bioscience said Thursday it will join a Bundibugyo virus vaccine development project backed by up to $99 million from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

The initiative, involving nonprofit research organizations IAVI and Hilleman Laboratories, has received $36 million in initial funding.

The project addresses BDBV outbreaks in the Democratic Republic of the Congo and other areas. With no BDBV-specific vaccine or treatment available, the partners plan to develop a single-dose vaccine and establish a reliable manufacturing and supply network. The funding will cover clinical and regulatory work, including Phase 1 trials, vaccine production and updated formulations targeting viral variants.

IAVI will oversee clinical trials and regulatory engagement, while Hilleman Laboratories will produce vaccines for early-stage trials and transfer the manufacturing technology. SK Bioscience will lead process scale-up and commercial-scale manufacturing, with its German subsidiary IDT Biologika responsible for aseptic filling and finished-product production.

The initiative builds on vaccine research previously supported by the Coalition for Epidemic Preparedness Innovations. The partners will use the recombinant vesicular stomatitis virus platform employed in a Zaire ebolavirus vaccine that received prequalification from the World Health Organization.

“The BARDA funding reflects confidence in the vaccine candidate and the capabilities of the participating organizations,” IAVI President and CEO Mark Feinberg said. “Combining IAVI’s clinical development and regulatory expertise with our partners’ manufacturing capabilities will strengthen preparedness for potential BDBV outbreaks.”

“The project draws on the combined capabilities of SK Bioscience and IDT,” SK Bioscience CEO Ahn Jae-yong said. “We will work with global partners to advance vaccine development and establish a stable supply chain.”

SK Bioscience is conducting a global Phase 3 trial of a 21-valent pneumococcal conjugate vaccine co-developed with Sanofi. The company has also licensed an injectable rotavirus vaccine candidate and is developing products including respiratory syncytial virus preventive antibodies and a universal coronavirus vaccine.