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[Kim Jin-soo, Edaily Reporter] On the 25th, SK Bioscience announced that it has begun a global Phase 1/2 clinical trial for its Japanese encephalitis vaccine candidate, GBP560, developed using mRNA technology.

SK Bioscience bio plant An-Dong L House. (SK Bioscience)

The development of vaccines for Japanese encephalitis and Lassa fever virus is part of SK Bioscience’s ‘100-Day Mission’ project, conducted in collaboration with international organizations to establish an mRNA vaccine platform in preparation for the next pandemic. The 100-Day Mission aims to develop and mass-produce a vaccine within weeks of an outbreak of an unknown infectious disease(Disease X) and respond to a pandemic within 100 days.

In 2022, SK Bioscience signed an agreement with the Coalition for Epidemic Preparedness Innovations(CEPI) to receive $40 million in initial R&D funding for the project. If the vaccine reaches the later stages of development, CEPI plans to provide SK Bioscience with up to an additional $100 million in funding.

SK Bioscience is playing a key role in global pandemic preparedness. The International Pandemic Preparedness Secretariat(IPPS) recently recognized SK Bioscience as a major CEPI vaccine R&D partner in its ‘100-Day Mission: 2024 Implementation Report.’

The mRNA vaccine platform technology, which was first commercialized through COVID-19 vaccines, offers a significant advantage in enabling rapid large-scale production using genetic sequencing, compared to traditional vaccine platforms. This makes it particularly suitable for pandemic response and holds strong potential for therapeutic drug development, leading to an expected rapid market expansion.

According to Nova One Advisor, a global market research firm, the global mRNA drug market is projected to grow at an annual rate of 17.06%, reaching $58.9 billion(KRW 84.5 trillion) by 2033.

GBP560, SK Bioscience’s first mRNA vaccine, is being tested in a Phase 1/2 clinical trial involving 402 healthy adult participants in Australia and New Zealand. The trial will assess the immunogenicity and safety of the vaccine after administration.

In stage 1, Participants will receive two doses of either a low, medium, or high dose of GBP560, or a placebo, at a 28-day interval. Tolerance and immune responses will be evaluated.

In stage 2, Based on stage 1 results, the optimal dosage and regimen will be determined, and a comparative evaluation of immunogenicity and safety will be conducted against a control group.

SK Bioscience aims to secure interim clinical trial results by next year. Preclinical studies have already confirmed GBP560’s safety and immunogenicity, including repeat-dose toxicity tests, safety pharmacology tests, animal efficacy studies, and immune challenge studies.

SK Bioscience and CEPI are committed to ensuring global equitable access to the vaccines under development. In accordance with the current agreement, SK Bioscience is prioritizing the supply of vaccines to low and middle income countries(LMICs), ensuring the production of sufficient doses for public health needs and offering affordable pricing to promote fair access.

Richard Hatchett, CEO of CEPI, stated “We don’t know when or where the next unknown infectious disease will emerge, but we all know that it is coming. By preparing vaccine development technology in advance based on the success of mRNA, we can avoid wasting time starting from scratch when another pandemic arises. This will enable us to respond to future infectious disease outbreaks quickly and equitably.”

Ahn Jae-yong, CEO of SK Bioscience, commented “Expanding technology through the mRNA platform will not only allow for rapid responses to unknown diseases but also ensure equitable access and sufficient vaccine supply. We will successfully conduct clinical trials to contribute to global public health and solidify our position as a leading company in vaccine R&D.”