SK Bioscience has launched a major effort to develop a universal vaccine that can protect against COVID-19 and other coronaviruses in the same family.
On October 15, the company said it submitted a global Phase 1/2 clinical trial protocol for its vaccine candidate GBP511 to an Australian Human Research Ethics Committee (HREC). GBP511 is designed to target sarbecoviruses, the subgenus that includes SARS and SARS-CoV-2, and is intended to provide cross-protection against existing variants and potential novel coronaviruses.
The planned trial will enroll about 500 healthy adults aged 18 and older in Australia and will assess safety and cross-reactive immune responses, with key readouts expected through 2028.
The GBP511 program began in 2021 during the COVID-19 pandemic through a collaboration between SK Bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI provided about $65 million in early R&D funding, covering nonclinical and clinical studies and process development.
GBP511 builds on the company’s recombinant protein-based technology used in Skycovione, South Korea’s domestically developed COVID-19 vaccine. The candidate combines SK Bioscience’s antigen and recombinant technology with self-assembling nanoparticle design from the University of Washington’s Institute for Protein Design. Skycovione previously demonstrated strong immunogenicity and safety in global trials.
While several firms and institutions worldwide are pursuing universal coronavirus vaccines, most remain in early preclinical stages. SK Bioscience’s move into a Phase 1/2 clinical trial is considered relatively rapid progress.
The World Health Organization in 2022 identified development of universal sarbecovirus vaccines as a global health priority, citing ongoing viral evolution, waning immunity, reinfection risk, and the potential for animal-to-human transmission. Experts say vaccines that deliver broad cross-protection and long-lasting immunity are essential to prevent future pandemics.
Market research firm Coherent Market Insights projects the global COVID-19 vaccine market will reach roughly $50.6 billion by 2025 and grow at a compound annual rate of 7.4% to about $83.4 billion by 2032, underscoring commercial potential for next-generation solutions like universal vaccines.
SK Bioscience CEO Ahn Jae-yong said, “Although the COVID-19 pandemic has ended, related viruses continue to evolve and threaten humanity. GBP511 is a next-generation vaccine designed to prevent viruses across the family regardless of specific variants, and it will mark a new turning point in pandemic preparedness.”
SK Bioscience is also advancing other pandemic-response candidates. In partnership with CEPI, an mRNA Japanese encephalitis vaccine is in global Phase 1/2 trials, and a government-collaborative avian influenza vaccine program began research and development this year.
