SK Bioscience Receives Approval for Global Clinical Plan of Japanese Encephalitis mRNA Vaccine

Goal to Secure Interim Results by 2026

SK Bioscience announced on the 12th that it has received approval from the Australian Human Research Ethics Committee for the Phase 1/2 clinical trial plan of the Japanese encephalitis vaccine candidate 'GBP560.'

Ahn Jae-yong, President of SK Bioscience.

GBP560 is one of the projects under the '100-Day Mission' to prepare for the next pandemic, conducted by SK Bioscience in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) to establish a messenger RNA (mRNA) vaccine platform. SK Bioscience signed an agreement in 2022 to receive initial research and development funding of 40 million USD from CEPI and will receive up to 100 million USD in the late development stage.

Starting February next year, SK Bioscience will evaluate the immunogenicity (the ability to induce immunity) and safety of GBP560 in 402 adults residing in Australia. Phase 1 will be conducted by administering low, medium, high doses, or a control drug twice at 28-day intervals. Phase 2 will set the dosage and administration method based on the results of Phase 1 and conduct comparative evaluation with a control group.

In this clinical trial, SK Bioscience plans to verify safety indicators such as the incidence of adverse events and serious adverse events, as well as virus neutralizing antibody titer responses, aiming to secure interim results by 2026.

Ahn Jae-yong, CEO of SK Bioscience, said, "The rapid development speed is the greatest advantage of mRNA vaccines, which are essential technologies to secure for pandemic preparedness. Based on networks with global organizations such as CEPI, companies, and the government of the Republic of Korea, we will successfully establish the mRNA platform and contribute to equitable access to vaccines, the promotion of global health, and securing vaccine sovereignty."

This content was produced with the assistance of AI translation services.