SK bioscience Launches Global Clinical Trials for mRNA Vaccine Against Japanese Encephalitis

SK bioscience, a cutting-edge vaccine and biotech company, has officially begun its Phase 1/2 clinical trials for an mRNA-based vaccine targeting Japanese encephalitis, known as GBP560. This pioneering effort aims to not only combat Japanese encephalitis but also serve as a prototype for developing rapid-response vaccines against future infectious disease threats, including those classified as 'Disease X'. This initiative aligns with the global '100 Day Mission', endorsed by prominent groups like CEPI, G7, and G20. The goal is to accelerate vaccine development to just over three months post-discovery of emerging pathogens, a critical step for global health security.

The trials will take place in Australia and New Zealand, with an initial focus on evaluating the safety and immunogenicity of GBP560 in a cohort of 402 healthy adult participants. The adaptive trial design will involve administering varying doses of the vaccine, followed by a control vaccine, to pinpoint the optimal dosage for future evaluations. Participants will receive their shots 28 days apart, with the first interim results projected for 2026.

This project has received significant backing from CEPI, with an initial funding commitment of USD 40 million to advance preclinical and early clinical research for both the Japanese encephalitis and Lassa fever virus vaccines. A potential additional investment of USD 100 million is expected to support late-stage trials and further ensure the mRNA technology's readiness in urgent outbreak situations.

The innovative mRNA platform, which gained prominence during the COVID-19 pandemic, allows for rapid production and deployment, making it particularly effective for responding to both planned and unexpected health emergencies. SK bioscience's ambitious vision extends beyond the immediate trials; the company is strategizing to create a versatile mRNA technology capable of tackling a variety of infectious diseases.

The potential of this technology is reflected in industry forecasts, such as research from 'Nova One Advisor', which anticipates that the global mRNA therapeutics market will soar to approximately USD 58.90 billion by 2033, with an annual growth rate of 17.06%. Thus, SK bioscience is positioning itself to be a formidable player in the rapidly evolving vaccine landscape.

Moreover, SK bioscience has committed itself to equitable global access to its vaccine outputs, particularly prioritizing supply for low- and middle-income countries as part of the funding agreement with CEPI. This pledge emphasizes the company's dedication to public health and its alignment with CEPI's Equitable Access Policy.

Dr. Richard Hatchett, CEO of CEPI, articulated the urgency of being proactive regarding potential infectious threats: "We don’t know when the next Disease X will strike... Preparing technologies ahead of time... allows us to respond effectively when it emerges."

Jaeyong Ahn, CEO of SK bioscience, shared similar sentiments, noting that the expansion of their capabilities with the mRNA platform will not only facilitate swift responses to new diseases but also ensure sufficient vaccine supplies and equitable access worldwide. Ahn expressed strong confidence in the pandemic preparedness strategy SK bioscience is advancing through these trials, underscoring the company's commitment to enhancing public health on a global scale.

In sum, the mRNA Japanese encephalitis vaccine trials mark a significant step forward in both the advancement of vaccine technology and the global response to potential health threats. Through collaboration, innovation, and commitment to equitable health access, SK bioscience is set to lead the charge in next-generation vaccine development, establishing itself as a pivotal partner in global health security efforts.