Application for Global Phase 1/2 Clinical Trial Plan Submitted in Australia
SK Bioscience is set to begin clinical trials for a "next-generation vaccine" designed to provide broad protection against a range of coronaviruses, including COVID-19.
A researcher at SK Bioscience is conducting analytical experiments for vaccine development. SK Bioscience
On October 15, SK Bioscience announced that it had submitted a global phase 1/2 clinical trial plan for its vaccine candidate "GBP511," which targets the sarbecovirus group-including COVID-19 and SARS (Severe Acute Respiratory Syndrome)-to the Human Research Ethics Committee (HREC) in Australia. Sarbecoviruses are a higher-level group that includes the COVID-19 virus, encompassing not only the current variants but also potential new coronaviruses that may emerge in the future. Rather than developing vaccines for individual viruses, SK Bioscience aims to create a vaccine effective against the entire group, establishing a universal vaccine platform that can prevent related viruses and variants simultaneously.
The clinical trial for GBP511 will be conducted in Australia, enrolling approximately 500 healthy adults aged 18 and older. The study will run through 2028 and will focus on assessing key outcomes such as safety and cross-immune response.
During the COVID-19 pandemic in 2021, SK Bioscience launched the GBP511 development project in partnership with the international organization CEPI (Coalition for Epidemic Preparedness Innovations). The company received about 65 million dollars (approximately 90 billion won) in initial R&D funding, covering preclinical studies, phase 1/2 clinical trials, and the development of manufacturing processes and analytical methods.
GBP511 utilizes core technology from "Skycovione," the only domestically developed COVID-19 vaccine in Korea to achieve commercialization in 2022 and the first vaccine designed using computer-based technology. The synthetic antigen platform of Skycovione is combined with SK Bioscience’s gene recombination technology and the self-assembling nanoparticle design technology from the Antigen Design Research Institute at the University of Washington School of Pharmacy in the United States. Skycovione has already demonstrated excellent immunogenicity and safety in global clinical trials.
In its January 2022 report, "Why do we need a pan-sarbecovirus vaccine?", the World Health Organization (WHO) highlighted the repeated emergence of variants, waning immunity, the possibility of reinfection, and the risk of animal-to-human transmission. The report designated the development of a universal vaccine capable of addressing various sarbecoviruses as a top priority for global health. Experts emphasize that a vaccine with broad cross-neutralizing ability and long-lasting immunity is the fundamental solution to preventing future pandemics.
According to global market research firm Coherent Market Insights, the global COVID-19 vaccine market is estimated to reach approximately 50.6 billion dollars (about 69 trillion won) in 2025. From 2025 to 2032, the market is expected to grow at an average annual rate of 7.4%, reaching about 83.4 billion dollars (about 113 trillion won) by 2032. This demonstrates that next-generation technologies, such as universal vaccines, have the potential to create new demand.
Ahn Jaeyong, CEO of SK Bioscience, stated, "Even though the COVID-19 pandemic has ended, related viruses continue to mutate and pose a constant threat to humanity. GBP511 aims to prevent a broad range of viruses regardless of mutations, helping us move beyond the reach of COVID-19 and respond to future pandemics as well."
Meanwhile, SK Bioscience is also building a variety of new pipelines to prepare for future pandemics in addition to GBP511. The mRNA Japanese encephalitis vaccine, being developed in collaboration with CEPI, is progressing smoothly through global phase 1/2 trials. The avian influenza vaccine, developed in partnership with the government, also began research and development this year. SK Bioscience plans to further strengthen its portfolio for responding to global health crises through the development of various vaccines.
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