SK bioscience has initiated a global phase -/II clinical trial in Australia for GBP511, a vaccine candidate targeting the sarbecovirus subgenus.

Sarbecoviruses are a higher-level coronavirus group that include SARS-CoV-2, encompassing not only currently circulating variants, but also potential future novel coronaviruses related SARS-like coronaviruses found in animals that could potentially spill over to humans. Or even just, related SARS-like coronaviruses found in animals.

SK bioscience aims to develop a universal vaccine capable of inducing broad immune responses across the entire virus family, and is establishing a platform applicable to multiple related viruses and variants.

The international phase-I/II trial of GBP511 will be conducted in approximately 368 adults aged 18 years and older in Australia. In phase I, participants will receive two doses administered 28 days apart, across low-, medium- and high-dose cohorts, with or without an adjuvant. Safety, tolerability and immunogenicity will be evaluated, including comparisons with Comirnaty, a comparator vaccine.

Based on phase-I results, the optimal dose and regimen will be selected, after which phase-II will assess immunogenicity and safety in adult and elderly populations, again comparing the investigational vaccine with Comirnaty, a comparator vaccine. In addition, the study will evaluate cross-reactive immune responses across the sarbecovirus family, including SARS-CoV-2, to assess the vaccine's potential as a universal coronavirus vaccine.

GBP511 incorporates the core technology of SKYCovione, which, in 2022, became the only domestically-developed COVID-19 vaccine in Korea to achieve commercialisation. Building on SKYCovione's computer-designed antigen platform, GBP511 combines SK bioscience's recombinant protein technology with self-assembling nanoparticle design technology developed by the Institute for Protein Design (IPD) at the University of Washington School of Medicine. SKYCovione has previously demonstrated robust immunogenicity and a favourable safety profile through global clinical trials.

SKYCovione demonstrated the induction of robust protective neutralising antibody levels and a favourable safety profile through global clinical trials, which was the basis of the vaccine's approval by several regulatory authorities.

Globally, while multiple companies and research institutions have initiated efforts to develop universal coronavirus vaccines, most programmes remain at an early research stage.

SK bioscience's entry into global phase-I/II clinical development is the first such vaccine to enter clinical trials, demonstrating a comparatively rapid pace of development.

The Coalition for Epidemic Preparedness Innovations (CEPI) has designated the SARS-coronavirus family as a "prototype pathogen," noting the high likelihood that future pandemics may repeatedly arise from the same viral family. CEPI has consistently emphasised the limitations of variant- or pathogen-specific approaches and highlighted the need for universal coronavirus vaccines capable of providing broad protection regardless of the emergence of novel viruses. CEPI is supporting the development of broadly protective coronavirus vaccines, which could potentially provide broad protection against the betacoronavirus family, which includes SARS and MERS.

Major international journals, including Nature Reviews Immunology and The Lancet Microbe, have likewise reported that universal sarbecovirus vaccines capable of delivering both broad cross-neutralising activity and durable immune protection could become a cornerstone of future pandemic preparedness strategies.

Against this backdrop, the COVID-19 vaccine market is expected to transition from short-term outbreak-driven demand to sustained mid- to long-term growth.

According to Coherent Market Insights, the global COVID-19 vaccine market is estimated at approximately USD 50.6 billion (KRW 70 trillion) in 2025 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 7.4 percent from 2025 to 2032, reaching approximately USD 83.4 billion (KRW 117 trillion) by 2032. Next-generation technologies, such as universal vaccines, are expected to generate new sources of market demand.

Dr Richard Hatchett, CEO, CEPI, said, "COVID 19 exposed the devastating price of confronting a deadly new virus without a vaccine. Broadly protective coronavirus vaccines have the power to change that story. While we cannot predict when or where the next coronavirus threat will emerge, we can prepare. By investing now in all-in-one vaccines, CEPI and its partners are strengthening global defences—and South Korea is playing a pivotal role in that effort. The progression of SK bioscience's broadly protective coronavirus vaccine into phase-I/II trials marks a major step forward, showcasing South Korea's leadership in cutting-edge vaccine innovation and bringing us closer to a safer future for all."

The company continues to advance a range of infectious disease pipelines, including a 21-valent pneumococcal conjugate vaccine and an avian influenza vaccine. It plans to progressively expand its vaccine portfolio to strengthen mid- to long-term preparedness for future infectious disease threats.

Jaeyong Ahn, CEO, SK bioscience, said, "Developing a universal sarbecovirus vaccine is a critical challenge that must be addressed to prepare for the next pandemic. With the initiation of the GBP511 clinical trial, we will accelerate the development of universal vaccines and leverage our proactive infectious disease preparedness capabilities to emerge as a global leader in the vaccine market."