SK bioscience Initiates Global Clinical Trials of mRNA Japanese Encephalitis Vaccine Candidate

• SK bioscience's first mRNA vaccine candidate enters Phase 1/2 clinical trials in Australia and New Zealand, with interim results expected by 2026
• Joint R&D project between SK and CEPI includes up to USD 40 million in initial funding support from CEPI
• SK bioscience will expand its vaccine portfolio and secure global competitiveness by developing mRNA vaccines

SEONGNAM, South Korea, Feb. 25, 2025 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced the commencement of global Phase 1/2 clinical trials for its mRNA-based Japanese encephalitis vaccine candidate, GBP560.

SK bioscience's development of vaccine for Japanese encephalitis could not only help to protect against Japanese Encephalitis but also pave the way to the development of an mRNA technology that could be potentially adapted in a matter of weeks to develop a vaccine against a novel as-yet-identified infectious disease 'Disease X'.

This rapid response approach would support the '100 Day Mission', a global initiative spearheaded by the Coalition for Epidemic Preparedness Innovations (CEPI) and embraced by the G7, G20 and pharmaceutical companies to accelerate the development of new vaccines against pandemic threats to just over three months following the identification of a Disease X.

This project is based on an R&D agreement with CEPI, which committed USD 40 million initial funding, in 2022 to support preclinical and early clinical trials of Japanese encephalitis as well as Lassa fever virus vaccines. A further USD 100 million in funding could be made available later to support late-stage trials/licensure to further validate the mRNA platform and have it ready for use in outbreak situations.

SK bioscience's leadership in next pandemic preparedness was recognized as a key R&D partner of CEPI in the '100 Day Mission Implementation Report 2024' recently published by the influential International Pandemic Preparedness Secretariat (IPPS), a global body set up to monitor global readiness for widespread disease outbreaks.

Through this project, SK bioscience aims to establish a mRNA vaccine technology capable of addressing not only pandemic threats but also various infectious diseases. By expanding its vaccine pipeline, the company seeks to enhance its competitiveness in the global vaccine industry.

The mRNA vaccine technology, which was first commercialized in the COVID-19 vaccines during the pandemic, is available for rapid mass production compared to traditional technologies by utilizing genetic sequences. This capability makes mRNA technology well-suited for pandemic response. Furthermore, the mRNA vaccine technology shows significant potential to be applied to the development of therapeutic drugs, signaling rapid market expansion.

According to global market research firm 'Nova One Advisor', the global mRNA therapeutics market is projected to surpass around USD 58.90 billion in 2033, registering a CAGR of 17.06% by 2033.

During the Phase 1/2 trials, the company will evaluate the immunogenicity and safety of GBP560, the company's first mRNA-based vaccine candidate, in 402 healthy adult participants in Australia and New Zealand. In stage 1, the participants will receive two shots of low, medium, high-dose vaccine, or a control vaccine administered 28 days apart. Based on the stage 1 results, the optimal dosage and regimen will be determined for further assessment of the immunogenicity and safety compared to the control group in stage 2. The company aims to secure interim results by 2026.

Previously, in preclinical studies, the vaccine candidate demonstrated superior safety and immunogenicity through repeated-dose toxicity studies, safety pharmacology tests, and preclinical protective immunity studies.

CEPI and SK bioscience are committed to enabling global equitable access to the vaccines they develop. Under the terms of the funding agreement, SK bioscience has committed to achieving equitable access to the outputs of this project including prioritization of supply for low-income and middle-income countries, production of vaccine volumes required to meet public health needs, and affordable pricing, in line with CEPI's Equitable Access Policy.

Dr Richard Hatchett, CEO of CEPI, said: "We don't know when the next Disease X will strike or where – but we know that it is coming. Preparing technologies ahead of time by building on the successes of mRNA allows us to not lose time creating a new vaccine from scratch when a viral threat emerges. This puts us on track to defeating a future outbreak quickly and equitably."

Jaeyong Ahn, CEO of SK bioscience, said, "Expanding our capabilities with the mRNA platform will enable rapid responses to unknown diseases while ensuring equitable access to vaccines and sufficient vaccine supply worldwide. We are committed to successfully advancing this clinical trial, contributing to public health and strengthening our position as a global leader in vaccine R&D." <END>

About SK bioscience

SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions.
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Changhyun Jin ([email protected]), Jeannie S. Pak ([email protected])

SOURCE SK bioscience