SK BIOSCIENCE announced on the 29th that it is participating in the vaccine development project alongside the International AIDS Vaccine Initiative (IAVI), an international nonprofit biomedical research organization, and the Hilleman Laboratories, among others.
This project is funded by up to $99 million (approximately 131 billion won) from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) under the Agency for Strategic Preparedness and Response (ASPR). Of this amount, the confirmed initial funding is $36 million (approximately 47.7 billion won).
This project aims to address the Bundibugyo virus (BDBV) outbreak, which has recently been spreading primarily in the Democratic Republic of the Congo (DRC). BDBV is one of the viruses that causes Ebola, and there are currently no vaccines or specific treatments available for it.
In particular, the Ebola outbreak in the Democratic Republic of the Congo—which, as of the end of last month, had recorded a cumulative total of 10,060 confirmed cases and 4,887 deaths—is the second-largest in history.
The funding will be allocated to clinical and regulatory activities—including Phase 1 clinical trials—as well as the production of vaccines to respond to the outbreak and their distribution to ensure public health security. Additionally, the project will pursue the development of follow-up vaccines that incorporate variant strains of the virus.
The organizations participating in the project plan to develop a vaccine that induces rapid immunity with a single dose and to establish a stable global supply base.
To this end, IAVI will oversee the program and manage clinical development and interactions with regulatory agencies, such as the U.S. Food and Drug Administration (FDA). The Hilleman Laboratories will be responsible for producing early-phase clinical trial vaccines using next-generation manufacturing processes and for technology transfer.
SK BIOSCIENCE will lead process scaling to expand production capacity and mass production. Its subsidiary, the contract development and manufacturing organization (CDMO) IDT Biologics, will handle aseptic filling and final product processing to produce the finished product.
Supported by the Coalition for Epidemic Preparedness Innovations (CEPI), this project complements and expands the vaccine development initiatives previously pursued by IAVI and the Hilleman Laboratories. The plan is to strengthen response capabilities in the event of an infectious disease outbreak, as well as the medium- to long-term production and supply infrastructure, by adding support from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to the existing development efforts.
The vaccine development will utilize the same recombinant vesicular stomatitis virus (rVSV) platform as the Zaire Ebola vaccine, which has received Prequalification (PQ) from the World Health Organization (WHO). SK BIOSCIENCE has previously collaborated with U.S.-based Merck (MSD), the Hilleman Laboratories, and CEPI to develop a next-generation Zaire Ebola vaccine and improve manufacturing processes.
Mark Fineberg, President and CEO of IAVI, stated, “This BARDA grant reflects deep confidence in the potential of the vaccine candidate and in our partners’ capabilities, technology, and commitment.” He added, “By combining IAVI’s accumulated expertise in rVSV vaccine development, clinical trials, and regulatory affairs with our partners’ outstanding manufacturing capabilities, we will significantly strengthen our preparedness for future Bundibugio virus pandemics.”
Raman Rao, CEO of the Hilleman Laboratories, said, “Close collaboration among all organizations is essential for vaccine development and production,” adding, “Hilleman Laboratories will work with our partners to facilitate technology transfer for the supply of vaccines for clinical trials and large-scale production, and contribute to the development of vaccines that enable a rapid response in the event of an infectious disease outbreak.”
Sally Choi, President of IDT Biologics, remarked, “I am deeply honored to be part of this important project,” adding, “Through collaboration with our partners, we will strengthen global preparedness against Ebola outbreaks and contribute to increasing access to life-saving vaccines.”
Ahn Jae-yong, President of SK BIOSCIENCE, said, “To proactively respond to the threat of infectious diseases, it is of the utmost importance to continuously secure a foundation for vaccine development and production.” He added, “Our participation in this project is a testament to the recognition of SK BIOSCIENCE and IDT’s collaborative capabilities in the global market. We will take the lead in the global response to infectious diseases by working closely with global partners to ensure the rapid development of vaccines and establish a stable supply chain.”
