SK bioscience Receives Approval for Global Clinical Trials of mRNA Japanese Encephalitis Vaccine Candidate

SK bioscience's first mRNA vaccine candidate is expected to enter clinical trials in Australia in February 2025,with interim results expected by 2026.

Joint R&D project betweenSK and CEPI includes up to USD 40 million in initial funding support from CEPI.

SK bioscience will respond to infectious diseases by expanding the development of mRNA vaccines.

SEONGNAM,South Korea,Dec. 12,2024 -- SK bioscience,a global innovative vaccine and biotech company committed to promoting human health from prevention to cure,announced today that it has received approval from the Human Research Ethics Committee (HREC) in Australia for the clinical trial protocols of a Phase 1/2 trials for its mRNA-based Japanese encephalitis vaccine candidate,GBP560.

SK bioscience is establishing mRNA platform supported by CEPI.

SK bioscience is establishing its mRNA vaccine platform through the development of vaccines against Japanese encephalitis virus as well as Lassa fever virus.

The Japanese Encephalitis Virus (viral family: Flaviviruses) and Lassa fever vaccines (viral family: Arenaviruses) will serve as prototype vaccines that could potentially be adapted in a matter of weeks for use against a future Disease X that might emerge from those same viral families. This approach is key to the 100 Days Mission,a global goal to accelerate the development of vaccines against pandemic threats to just over three months.

This joint project is based on an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI),which committed up to USD 40 million initial funding (approximately KRW 57.4 billion) in funding in 2022 to support preclinical and early clinical trials. A further USD 100 million in funding could be made available at a later date to support late-stage trials/licensure to further validate the mRNA platform and have it ready for use in outbreak situations.

The partnership builds upon SK bioscience's expertise in cutting-edge vaccine platforms such as cell culture,bacterial culture,and recombinant technology. By expanding the company's capabilities to include the mRNA platform,the collaboration aims to be ready to rapidly respond to Disease X and contribute to equitable access to vaccines,including through a contractual commitment to,if successful,prioritize supply for low-and middle-income countries,produce vaccine volumes required to meet public health needs,and ensure affordable pricing.

The mRNA vaccine platform technology,which was first commercialized in the COVID-19 vaccines during the pandemic,is available for rapid mass production compared to traditional platforms by utilizing genetic sequences. This capability makes mRNA technology well-suited for pandemic response. Furthermore,the mRNA vaccine platform 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 (approximately KRW 84.5 trillion) by 2033,registering a CAGR of 17.06% by 2033.

The company will evaluate the immunogenicity and safety of GBP560 in 402 healthy adult participants in Australia. 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.

During the Phase 1/2 trials,SK bioscience plans to confirm neutralizing antibody titers and immune responses,along with collecting data on major adverse events,safety indicators,and the rate of adverse reactions. The company aims to secure interim results by 2026.

Previously,the company conducted preclinical studies beginning in December 2023,where the vaccine candidate demonstrated superior safety and immunogenicity through repeated-dose toxicity studies,safety pharmacology tests,animal efficacy trials,and protective immunity tests.

Dr. Kent Kester,Executive Director of Vaccine Research and Development at CEPI said,"mRNA technology is at the heart of CEPI's work to build a library of vaccine candidates that could be swiftly adapted next time Disease X emerges. Our work with SK bioscience aims to validate the rapid response mRNA platform against viruses from two of the viral families with the potential to spawn future epidemics and pandemics,contributing to the 100 Days Mission and to building a safer world for all."

Jaeyong Ahn,CEO of SK bioscience,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 organizations,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 also supported the development of SK bioscience's COVID-19 vaccine and is funding an ongoing project to support a broadly protective coronavirus vaccine.

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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Communications Team

Changhyun Jin ([email protected]),Jeannie S. Pak ([email protected])