SK bioscience begins human trials for universal coronavirus vaccine

SEONGNAM, South Korea - SK bioscience, a prominent player in the Biotechnology industry according to InvestingPro data, announced Wednesday it has submitted a Phase 1/2 clinical trial application in Australia for GBP511, a universal coronavirus vaccine candidate designed to protect against COVID-19 variants and related sarbecoviruses.

The trial will enroll approximately 500 healthy adults aged 18 and older to evaluate safety and cross-reactive immunogenicity, with topline results expected by 2028, according to the company’s press release statement.

GBP511 aims to provide broad protection across the sarbecovirus family, which includes SARS-CoV-2 (COVID-19), the original SARS virus, and related variants. The vaccine candidate builds on SK bioscience’s recombinant protein platform previously used in SKYCovione, Korea’s first domestically developed COVID-19 vaccine approved in 2022.

The development program began in 2021 with approximately $65 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine incorporates self-assembling nanoparticle design technology from the University of Washington Medicine’s Institute for Protein Design. The company maintains a strong financial position, holding more cash than debt on its balance sheet, with liquid assets exceeding short-term obligations.

"Even as the COVID-19 pandemic has eased, related viruses continue to evolve and pose global health risks," said Jaeyong Ahn, CEO of SK bioscience, in the statement. While analysts anticipate sales growth in the current year, detailed financial projections and 8 additional key insights are available on InvestingPro.

The World Health Organization has previously highlighted the need for broad-spectrum coronavirus vaccines due to the repeated emergence of variants, waning immunity, and zoonotic spillover risks.

SK bioscience is also advancing other pandemic-preparedness programs, including an mRNA-based Japanese encephalitis vaccine in Phase 1/2 global studies and a government-backed avian influenza vaccine program launched earlier this year.

In other recent news, SK bioscience has taken a significant step by submitting an Investigational New Drug (IND) application to South Korea’s Ministry of Food and Drug Safety. This application is for Phase 1/2 clinical trials of its new influenza vaccine candidate, NBP607B. The vaccine candidate includes an adjuvant designed to enhance the protective efficacy of its existing cell-based influenza vaccine, SKYCellflu. This adjuvant was developed by the Vaccine Formulation Institute, a Swiss-based non-profit organization, and is intended to boost immune responses, particularly in elderly individuals. These developments mark SK bioscience’s ongoing efforts to advance its vaccine portfolio.

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