SK Bioscience mRNA Vaccine, Global Clinical Trials Begin

Global Phase 1/2 Trials Begin in Australia and New Zealand; Interim Results Targeted for Next Year
CEPI to Provide Up to $140 Million in R&D Funding; Project Aims to Prepare for the Next Pandemic

SK Bioscience announced on the 25th that it has started the global Phase 1/2 clinical trial of 'GBP560,' a Japanese encephalitis vaccine candidate developed using mRNA technology.

A researcher at SK Bioscience is conducting experiments related to mRNA vaccine development. SK Bioscience

The development of vaccines for Japanese encephalitis and Lassa fever virus is part of SK Bioscience's '100-Day Mission' project to prepare for the next pandemic, conducted in collaboration with international organizations to establish an mRNA vaccine platform.

The '100-Day Mission' aims to develop and mass-produce vaccines within weeks after the outbreak of an unknown infectious disease (Disease-X) to respond to a pandemic within 100 days. In 2022, SK Bioscience signed an agreement with the international organization CEPI (Coalition for Epidemic Preparedness Innovations) to receive an initial $40 million in research and development funding and began the project. Upon entering the later development stages, CEPI plans to provide up to an additional $100 million to SK Bioscience.

SK Bioscience plays a key role in the global response to the next pandemic, being introduced as a major vaccine R&D partner of CEPI in the '100-Day Mission: 2024 Implementation Report' recently published by the International Pandemic Preparedness Secretariat (IPPS), a global non-profit organization.

Through this project, SK Bioscience plans to secure mRNA vaccine platform technology capable of responding to various diseases beyond pandemic response and to build a new pipeline to establish global competitiveness.

The mRNA vaccine platform technology, first commercialized in COVID-19 vaccines, has the advantage of enabling rapid mass production systems compared to existing platforms by utilizing genetic nucleotide sequences. This makes it favorable for pandemic response and increases the potential for application in therapeutic development, anticipating rapid market expansion.

The Phase 1/2 clinical trial of GBP560, SK Bioscience's first mRNA vaccine under development, will be conducted by evaluating immunogenicity and safety in 402 healthy adults residing in Australia and New Zealand. Phase 1 involves administering two doses of low, medium, high doses, or placebo at 28-day intervals to assess tolerability and immunogenicity. Based on Phase 1 results, Phase 2 will set the dosage and regimen to compare immunogenicity and safety against a control group.

SK Bioscience aims to secure interim results of the Phase 1/2 clinical trial next year. GBP560 has already confirmed safety and immunogenicity through repeated dose toxicity tests, safety pharmacology tests, animal efficacy tests, and antibody-dependent enhancement tests in preclinical studies.

Richard Hatchett, CEPI CEO, said, "No one knows when or where the next unknown infectious disease will strike, but everyone knows it is coming. By preparing vaccine development technology in advance based on the success of mRNA, we can avoid wasting time creating vaccines from scratch when another pandemic occurs. This will open the way for us to overcome future infectious disease outbreaks quickly and equitably."

Ahn Jae-yong, President of SK Bioscience, stated, "With the expansion of technology through the mRNA platform, we will secure rapid response to unknown diseases along with equitable access and sufficient supply of vaccines. We will successfully conduct clinical trials to contribute to global public health and strengthen our position as a leading company in vaccine R&D."

This content was produced with the assistance of AI translation services.