SK bioscience has gained Australia’s Human Research Ethics Committee (HREC) approval to begin Phase I/II clinical trials of GBP560, an mRNA-based Japanese encephalitis vaccine candidate.
The company is working to establish its mRNA vaccine platform, targeting diseases such as Japanese encephalitis and Lassa fever.
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SK bioscience will assess the safety and immunogenicity of GBP560 in 402 healthy adult subjects in Australia. The first stage involves administering two doses of the vaccine or a control vaccine at different dosages, 28 days apart, to determine the ideal dosage for further trials.
The Phase I/II trials aim to confirm neutralising antibody titers, and immune responses, and collect data on safety indicators, major adverse events and adverse reaction rates.
Interim results are expected by 2026. Preclinical studies for GBP560 began in December last year, showing promising safety and immunogenicity outcomes.
Japanese encephalitis and Lassa fever vaccines are being developed as prototypes that could be quickly adapted to combat a future Disease X from the same viral families.
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By GlobalDataThis strategy aligns with the ‘100 Days Mission’ to expedite vaccine development for pandemic threats to just over three months.
The project is supported by an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI), which provided an initial $40m in 2022 for early-stage trials, with a potential additional $100m for late-stage trials and licensure.
The company is committed to prioritising vaccine supply for low-income and middle-income countries, meeting public health needs, and ensuring affordability.
SK bioscience CEO Jaeyong Ahn said: “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 organisations, 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 support extends beyond this vaccine, having also backed SK bioscience’s Covid-19 vaccine development and is funding a project for a broadly protective coronavirus vaccine.
In June 2023, SK bioscience and Sanofi reported positive outcomes from the Phase II trials of GBP410 (SP0202).
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