SK bioscience has received the green light from Australia's Human Research Ethics Committee (HREC) to commence Phase I/II clinical trials for GBP560, an mRNA-based vaccine candidate targeting Japanese encephalitis. This marks a significant step in the company's efforts to establish a robust mRNA vaccine platform capable of addressing emerging infectious diseases.
The Phase I/II trials will evaluate the safety and immunogenicity of GBP560 in 402 healthy adult volunteers in Australia. The study will involve administering two doses of the vaccine or a control, with varying dosages given 28 days apart to determine the optimal dosage for subsequent trials. Researchers will monitor neutralizing antibody titers, immune responses, safety indicators, major adverse events, and adverse reaction rates. Interim results are anticipated by 2026.
mRNA Platform Development and CEPI Partnership
SK bioscience is focusing on developing mRNA vaccines against Japanese encephalitis and Lassa fever, with these serving as prototypes that can be rapidly adapted to combat future Disease X threats from the same viral families. This strategy aligns with the '100 Days Mission,' a global initiative to accelerate vaccine development for pandemic threats to just over three months.
This project is backed by a collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed an initial USD 40 million in funding to support preclinical and early clinical trials. An additional USD 100 million may be available to support late-stage trials and licensure, further validating the mRNA platform for outbreak situations.
Strategic Implications and Future Directions
The partnership leverages SK bioscience's expertise in cell culture, bacterial culture, and recombinant technology, expanding its capabilities to include the mRNA platform. The goal is to be prepared to respond swiftly to Disease X, ensuring equitable access to vaccines by prioritizing supply for low- and middle-income countries, meeting public health needs, and ensuring affordable pricing.
Jaeyong Ahn, CEO of SK bioscience, emphasized the importance of the mRNA vaccine platform for pandemic preparedness, stating, "The mRNA vaccine platform, with its rapid development cycle, is a critical tool for pandemic preparedness. By leveraging our strong network of various partners, including international organizations, global companies, and the Korean government, SK bioscience is committed to successfully establishing the mRNA technology platform and contributing to global health, equitable access to vaccines, and vaccine sovereignty."
CEPI's Dr. Kent Kester noted, "mRNA technology is at the heart of CEPI's work to build a library of vaccine candidates that could be swiftly adapted next time Disease X emerges. Our work with SK bioscience aims to validate the rapid response mRNA platform against viruses from two of the viral families with the potential to spawn future epidemics and pandemics, contributing to the 100 Days Mission and to building a safer world for all."
Market Growth and Future Applications
The mRNA vaccine platform, first commercialized during the COVID-19 pandemic, allows for rapid mass production using genetic sequences, making it ideal for pandemic response. The global mRNA therapeutics market is projected to exceed USD 58.90 billion by 2033, with a CAGR of 17.06%, according to Nova One Advisor.
