SK Bioscience approved for Japanese encephalitis vaccine trial in Australia

SK Bioscience announced Thursday that it has received approval from Australia’s Human Research Ethics Committee to start Phase 1/2 clinical trials for GBP560, an mRNA-based vaccine candidate targeting Japanese encephalitis, a mosquito-borne disease that can cause severe neurological complications.

The vaccine is part of the 100 Days Mission, an initiative by the Coalition for Epidemic Preparedness Innovations seeking to enable the world to produce a vaccine within 100 days of the outbreak of a new potential pandemic. The company said the initiative focuses on mRNA technology, which enables faster development and large-scale production than traditional methods.

The clinical trial, set to begin in February 2025, will involve 402 healthy adults in Australia. SK Bioscience said Phase 1 will test three dosage levels of the vaccine and a placebo to evaluate safety and immune response. Phase 2 will focus on determining the optimal dose and further evaluating its efficacy. Interim results are expected by 2026.

“We are committed to advancing mRNA technology to enhance global preparedness against infectious diseases,” SK Bioscience CEO Ahn Jae-yong said.

Preclinical studies over the past year have already confirmed the vaccine’s safety and effectiveness in animals, the company added. The project, supported by $40 million in initial funding from CEPI, has an additional $100 million pledged for further development, SK said.

Known for its COVID-19 vaccine Skycovione, SK Bioscience said it is also collaborating with CEPI on a universal coronavirus vaccine. The company said it aims to expand its portfolio of innovative solutions for global health while ensuring vaccine sovereignty and equitable access to immunizations worldwide.