SK Bioscience will start a global trial for its mRNA vaccine

to expand its platform

Commences GBP560 global Phase I/II trial in Australia and New Zealand... aiming to secure interim results next year

Part of its Next Pandemic Response Project, CEPI provides R&D funding of USD 140 million

SK Bioscience's messenger ribonucleic acid (mRNA) vaccine has entered full-scale clinical trials.

 

SK Bioscience announced on the 25th that it has begun Phase I/II global clinical trials of GBP560, a Japanese encephalitis mRNA vaccine candidate.

 

The Phase I/II clinical trial will involve 402 healthy adults living in Australia and New Zealand.

 

It will be conducted to evaluate the immunogenicity and safety of the vaccine after vaccination.

 

In the first stage, the tolerability and immunogenicity of the subjects will be checked after administering low, medium, high, or control doses twice at 28-day intervals.

 

In the second stage, the dosage and administration method will be set based on the results of the first stage, and the immunogenicity and safety will be evaluated by comparing it with the control group.

 

SK Bioscience plans to secure interim results from the GBP 560 Phase I/II clinical trial next year.

 

Previously, SK Bioscience confirmed the safety and immunogenicity of the candidate substance through repeated dose toxicity tests, safety pharmacology tests, animal efficacy tests, and immune-mediated attack tests in the GBP 560 non-clinical trial.

 

The development of the Japanese encephalitis vaccine is part of the '100-day Mission' project to prepare for the next pandemic, which SK Bioscience is conducting with international organizations to establish an mRNA vaccine platform.

 

The 100-day Mission aims to develop and mass-produce a vaccine within 100 days of the outbreak of an unknown infectious disease (Disease-X) to respond to the pandemic within 100 days.

 

SK Bioscience signed an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) in 2022 to receive an initial research and development grant of USD 40 million and launched the project.

 

When it enters the later development stage, CEPI will provide SK Bioscience with up to an additional USD 100 million.

 

Through this project, SK Bioscience aims to secure mRNA vaccine platform technology that can respond to pandemics and various diseases, and establish a new pipeline to gain global competitiveness.

 

Jae-Yong Ahn, President and Chief Executive Officer of SK Bioscience, said, “If the technology is expanded with the mRNA platform, we will be able to respond quickly to unknown diseases and ensure fair access to vaccines and sufficient supply.

 

We will conduct clinical trials successfully to contribute to global public health and solidify our position as a vaccine R&D leader.”