Biotech company SK bioscience announced on Thursday that it has received approval from Australia's Human Research Ethics Committee for Phase 1/2 clinical trials of its mRNA-based Japanese encephalitis vaccine candidate, GBP560.

This initiative is part of the company's broader effort to establish an mRNA vaccine platform targeting Japanese encephalitis and Lassa fever viruses. These vaccines will serve as prototypes for rapid adaptation against potential future Disease X threats, supporting the global 100 Days Mission to accelerate pandemic vaccine development.

The project is backed by the Coalition for Epidemic Preparedness Innovations (CEPI), which committed up to USD40m in 2022 for preclinical and early clinical trials, with an additional USD100m potentially available for late-stage trials. SK bioscience aims to prioritize equitable vaccine access for low- and middle-income countries, ensuring affordability and sufficient production capacity for public health needs.

Phase 1/2 trials in Australia will assess GBP560's immunogenicity and safety in 402 adult participants, with results guiding optimal dosage and regimen for further evaluation. Interim trial results are expected by 2026, following promising preclinical findings in safety and immunogenicity. This initiative highlights the potential of mRNA technology for pandemic response and therapeutic development, a market projected to reach USD58.90bn by 2033.