SK Bioscience Advances Universal COVID-19 Vaccine Development on Schedule

SK bioscience Launches Trials for Next-Generation Coronavirus vaccine

Seoul, South Korea – October 15, 2025 – SK Bioscience has initiated clinical trials for a groundbreaking vaccine, designated GBP511, designed to combat a wide spectrum of coronaviruses, including the virus responsible for COVID-19. This development marks a significant step toward creating a more resilient defense against both existing and emerging viral threats.

A Broad-Spectrum Approach to Viral Immunity

The company announced on Tuesday that it has submitted a plan for global phase 1/2 clinical trials to the Australian Human Research Ethics committee (HREC). GBP511 targets the Sabeco virus family, which encompasses COVID-19 and Severe Acute Respiratory Syndrome (SARS), and also potential future coronaviruses. Unlike current vaccines designed to address specific strains, SK Bioscience aims to establish a universal vaccine platform capable of neutralizing a range of related viruses and their evolving variants.

Clinical Trial details

The trials, expected to conclude by 2028, will involve approximately 500 healthy adult participants in Australia. Researchers will focus on evaluating the vaccine’s safety profile and its ability to generate cross-immune responses, indicating protection against diverse coronavirus strains. According to the World Health Organization, global surveillance of emerging infectious diseases is more critical than ever.

This project gained momentum in 2021, during the height of the COVID-19 pandemic, with the support of the Coalition for Epidemic Preparedness Innovations (CEPI). SK bioscience received roughly $65 million (approximately KRW 90 billion) to fund initial research and development efforts, including preclinical studies, phase 1/2 clinical trials, and analytical method development.

Leveraging Prior Success: Skycovione Technology

The development of GBP511 builds upon the success of Skycovione, Korea’s first domestically produced COVID-19 vaccine, which was successfully commercialized in 2022. Skycovione was notably the first vaccine of its kind designed using computer-based technology.SK Bioscience integrated its genetic recombination technology and the self-binding nanoparticle design expertise of the Antigen Design Institute (IPD) at the university of Washington College of Pharmacy into the GBP511 platform.

“Despite the waning of the pandemic, the threat of evolving viruses remains constant,” stated Jaeyong Ahn, CEO of SK Bioscience. “GBP511 is conceived to provide overarching viral protection, irrespective of mutations. Our goal is to safeguard against the ongoing impact of coronavirus and prepare for future pandemic challenges.”

Vaccine	Technology	Target	Trial Phase
Skycovione	Synthetic Antigen	COVID-19	Commercialized (2022)
GBP511	Synthetic Antigen, Genetic Recombination, nanoparticle Design	Sabeco Virus Family (COVID-19, SARS, Future Coronaviruses)	Phase 1/2

Did You Know? The Sabeco virus family is a broad group of viruses that includes several coronaviruses known to cause disease in humans and animals.

Pro tip: Staying informed about emerging infectious diseases and supporting research into broad-spectrum vaccines is crucial for global health security.

What role do you beleive international collaboration plays in pandemic preparedness? How important is the development of universal vaccines in safeguarding public health?

The Future of Coronavirus Vaccine Development

The pursuit of universal coronavirus vaccines represents a paradigm shift in infectious disease prevention. Historically, vaccine development has focused on specific pathogens. However, the rapid emergence of variants, as seen with COVID-19, underscores the need for vaccines that can provide broader protection. The technologies employed in GBP511-synthetic antigens, genetic recombination, and nanoparticle design-represent cutting-edge advancements in vaccine engineering. These approaches hold promise for creating vaccines that are more adaptable and effective against a wider range of viral threats. Furthermore, the collaborative efforts between organizations like SK bioscience and CEPI highlight the importance of international partnerships in addressing global health challenges.

Frequently Asked Questions about GBP511

• What is the primary goal of the GBP511 vaccine? The primary goal is to develop a vaccine that provides broad protection against the Sabeco virus family, including current and future coronavirus variants.
• What is the phase 1/2 clinical trial for GBP511? It’s a study involving around 500 adults in Australia to evaluate the vaccine’s safety and immune response.
• How does GBP511 differ from existing COVID-19 vaccines? Unlike many existing vaccines, GBP511 aims for universal protection rather than targeting specific strains.
• What role did CEPI play in the development of GBP511? CEPI provided significant funding for the initial research and development of the vaccine.
• What technology underpins the GBP511 vaccine? The vaccine utilizes a synthetic antigen platform, genetic recombination technology, and nanoparticle design.
• When are the clinical trials expected to be completed? The trials are expected to conclude by 2028.
• Is GBP511 a response to the ongoing COVID-19 pandemic? While developed during the pandemic, GBP511 aims to prepare for future coronavirus outbreaks, irrespective of mutations.

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What are teh key differences between GBP510 and first-generation COVID-19 vaccines in terms of their target proteins?

Progress on GBP510: A Next-Generation COVID-19 Solution

SK Bioscience, a leading south Korean pharmaceutical company, is reporting significant progress in the development of its universal COVID-19 vaccine candidate, GBP510. This vaccine aims to provide broader and longer-lasting protection against current and future variants of the SARS-CoV-2 virus, moving beyond the limitations of first-generation vaccines. The development timeline remains on track, with promising results emerging from ongoing clinical trials. This is crucial as the world continues to grapple with evolving strains and the need for sustained immunity.

Understanding the GBP510 Approach: A Novel Vaccine Platform

Unlike many existing COVID-19 vaccines that target the spike protein, GBP510 utilizes a novel approach focusing on the highly conserved nucleocapsid (N) protein. This protein is less prone to mutation, making it a more stable target for a universal coronavirus vaccine.

Here’s a breakdown of the key features:

* N-Protein Focus: Targeting the nucleocapsid protein offers broader protection against variants.

* Adjuvant Technology: SK Bioscience is leveraging advanced adjuvant technology to enhance the immune response. this is vital for generating robust and durable immunity.

* Next-Generation Platform: GBP510 is built on a cutting-edge vaccine platform designed for rapid adaptation to emerging viral threats.

* Potential for Combined Boosting: Research suggests GBP510 could be effectively used as a booster shot alongside existing mRNA vaccines, possibly amplifying protection.

Clinical Trial Updates & Key Findings (as of October 15, 2025)

Phase 1 and 2 clinical trials of GBP510 have demonstrated encouraging results regarding safety and immunogenicity.

* Phase 1 Results: Showed a strong immune response with minimal adverse effects in healthy adults.

* Phase 2 Results: Confirmed the safety profile and demonstrated a broader antibody response against multiple variants of concern, including Delta, Omicron, and emerging subvariants.

* Phase 3 Initiation: Phase 3 trials are currently underway, involving a larger cohort of participants across multiple countries to assess efficacy in preventing symptomatic COVID-19 infection. Initial enrollment data is positive.

* T-Cell Response: Importantly, GBP510 has demonstrated a robust T-cell response, which is crucial for long-term immunity and protection against severe disease. This is a key differentiator from some existing vaccines.

The Importance of a Universal COVID-19 Vaccine

The continued emergence of new COVID-19 variants highlights the limitations of current vaccines, which often require frequent updates to maintain efficacy. A pan-coronavirus vaccine like GBP510 offers several advantages:

* Variant Protection: Provides broader protection against existing and future variants.

* Reduced Booster Frequency: potentially eliminates the need for frequent booster shots tailored to specific variants.

* Long-Lasting Immunity: Aims to induce durable immunity, offering sustained protection over time.

* Public Health Impact: Could significantly reduce the burden of COVID-19 on healthcare systems and economies globally.

* Addressing Vaccine Equity: A more stable and broadly protective vaccine could simplify distribution and improve access in resource-limited settings.

Manufacturing and Distribution Plans

SK Bioscience is proactively scaling up manufacturing capacity to ensure a sufficient supply of GBP510 should it receive regulatory approval. The company has established partnerships with global pharmaceutical manufacturers to expedite production and distribution.

* Capacity Expansion: Investments are being made to expand manufacturing facilities in South Korea and potentially establish new production sites internationally.

* Global Partnerships: Collaborations with established pharmaceutical companies will facilitate rapid distribution to key markets.

* Supply chain Security: SK Bioscience is prioritizing the establishment of a robust and resilient supply chain to mitigate potential disruptions.

Regulatory Pathway & Expected Timeline

SK Bioscience is working closely with regulatory agencies, including the U.S.Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to expedite the review and approval process for GBP510.

* Rolling Submission: A rolling submission of data to regulatory agencies is underway.

* Emergency Use Authorization (EUA): Depending on the Phase 3 trial results, SK Bioscience may seek EUA to accelerate access to the vaccine.

* Full Approval: Full regulatory approval is anticipated in late 2026 or early 2027, contingent on accomplished completion of clinical trials and review by regulatory authorities.

Implications for Future Pandemic Preparedness

The development of GBP510 represents a significant step forward in pandemic preparedness. The technology and knowledge gained from this project can be applied to the development of vaccines against other emerging infectious diseases. mRNA vaccine technology and the focus on conserved viral proteins are key lessons learned. This proactive approach is essential for mitigating the impact of future pandemics.

Benefits of GBP510: A Summary

Benefit	Description

| Broad Variant Protection | Targets the N-protein, less prone