• 30 Jan 2026
• Admin
• News Article

SK bioscience Initiates Global Phase 1/2 Trial for Universal Sarbecovirus Vaccine GBP511

SK bioscience has initiated a global Phase 1/2 clinical trial in Australia for GBP511, a next-generation vaccine candidate designed to target the sarbecovirus family.

Sarbecoviruses include SARS-CoV-2, its variants, and related SARS-like coronaviruses found in animals that may spill over to humans.

The goal: develop a universal vaccine capable of inducing broad immune protection across this entire virus family.

Why GBP511 is Different?

GBP511 is built to go beyond variant-specific COVID-19 vaccines.

SK bioscience aims to create a platform that:

• Generates broad cross-reactive immune responses
• Covers current and future sarbecoviruses
• Supports long-term pandemic preparedness

This approach aligns with global calls for family-wide coronavirus vaccines rather than single-pathogen solutions.

Phase 1/2 Trial Design

The international study will enroll approximately 368 adults (≥18 years) in Australia.

Phase 1

Participants receive two doses, 28 days apart:

• Low-, medium-, and high-dose cohorts
• With or without adjuvant

Evaluations include:

• Safety and tolerability
• Immunogenicity
• Comparisons with Comirnaty as a comparator vaccine

Phase 2

Based on Phase 1 results, the optimal dose and regimen will be selected.

Phase 2 will assess:

• Immunogenicity and safety in adults and elderly populations
• Comparisons with Comirnaty
• Cross-reactive immune responses across the sarbecovirus family, including SARS-CoV-2

Technology Behind GBP511

GBP511 incorporates core technology from SKYCovione, SK bioscience’s recombinant protein-based COVID-19 vaccine commercialized in Korea in 2022.

Key components include:

• Computer-designed antigen platform
• Recombinant protein technology
• Self-assembling nanoparticle design from the Institute for Protein Design (University of Washington)

SKYCovione demonstrated:

• Robust neutralizing antibody responses
• Favorable safety profile
• Regulatory approvals in multiple countries

Strategic Importance

While many organizations are researching universal coronavirus vaccines, most programs remain in early discovery.

GBP511’s entry into global Phase 1/2 trials positions SK bioscience among the first to reach clinical development in this space.

The Coalition for Epidemic Preparedness Innovations (CEPI) has identified the SARS-coronavirus family as a prototype pathogen, highlighting the high likelihood of future pandemics emerging from this group.

Market Outlook

The COVID-19 vaccine market is expected to shift toward sustained, long-term demand.

• Estimated market size in 2025: USD 50.6 billion
• Projected to reach USD 83.4 billion by 2032
• CAGR (2025–2032): 7.4%

Next-generation vaccines, including universal platforms, are expected to drive new growth.

Executive Perspectives

Dr. Richard Hatchett, CEO, CEPI:

Broadly protective coronavirus vaccines have the power to change how the world confronts future outbreaks. The progression of SK bioscience’s vaccine into Phase 1/2 trials marks a major step forward and highlights South Korea’s leadership in vaccine innovation.

Jaeyong Ahn, CEO, SK bioscience:

Developing a universal sarbecovirus vaccine is a critical challenge for preparing for the next pandemic. With the initiation of the GBP511 trial, we aim to accelerate universal vaccine development and emerge as a global leader in the vaccine market.

Beyond GBP511

SK bioscience is also advancing:

• A 21-valent pneumococcal conjugate vaccine
• An avian influenza vaccine

The company plans to continue expanding its infectious disease pipeline to strengthen long-term global preparedness.