SK bioscience has initiated an international Phase I/II study in Australia for GBP511, a universal sarbecovirus vaccine candidate.
The trial will evaluate the vaccine’s ability to generate broad immune responses against the sarbecovirus subgenus, which includes severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and related SARS-like coronaviruses found in animals that have the potential to cause future outbreaks.
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It will enrol approximately 368 adults aged 18 years and above. During Phase I, participants will be given two GBP511 doses, spaced 28 days apart, across low, medium, and high dosage groups.
The study will use both formulations with and without an adjuvant and will assess the tolerability, immunogenicity, and safety by comparing results with those from Comirnaty, a comparator vaccine.
Based on the outcomes from Phase I, researchers will select the optimal dose and regimen. Following this, Phase II will further assess immunogenicity and safety in both adult and elderly groups, again using Comirnaty as a comparison.
The trial will also measure cross-reactive immune responses within the sarbecovirus family, including activity against SARS-CoV-2, to determine GBP511’s potential as a universal coronavirus vaccine.
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By GlobalDataGBP511 uses core technology from SKYCovione, the only domestically developed Covid-19 vaccine in Korea to reach commercialisation in 2022.
The vaccine combines SK bioscience’s recombinant protein platform with self-assembling nanoparticle technology from the Institute for Protein Design at the University of Washington School of Medicine.
SKYCovione showed strong immunogenicity and a favourable safety profile in previous global trials.
SK bioscience CEO Jaeyong Ahn 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.”
In January 2025, SK bioscience and Sanofi announced plans for global Phase III studies that would assess the safety and immunogenicity of their 21-valent pneumococcal conjugate vaccine candidate, GBP410, in more than 7,700 subjects aged six weeks to 17 years.
