The Korean-developed COVID-19 vaccine GBP510, is administered to phase 3 clinical trial subjects for the first time in Korea
The trial will evaluate the vaccine’s safety and immunogenicity on 4,000 global participants

SK bioscience (SK) announced on September 30th the initiation of phase 3 clinical trial of GBP510, a self-developed protein-based COVID-19 vaccine candidate under joint development with the Institute for Protein Design (IPD) of The University of Washington.

It is the first COVID-19 vaccine candidate developed in South Korea to be approved for the phase 3 clinical trial. GBP510 received the Investigational New Drug (IND) approval from the Korean Ministry of Food and Drug Safety (MFDS) 3 weeks ago.

The randomized and active controlled trial with an enrollment of around 4,000 participants over the age of 18 will be conducted in a range of countries and at 14 domestic facilities including the Korea University Guro Hospital, and international organizations in Europe and Southeast Asia. The trial of GBP510, a synthetic antigen vaccine made with genetic recombination technology in combination with GlaxoSmithKline (GSK)´s pandemic adjuvant will be administered intramuscularly twice at a 28-day interval.

SK bioscience is also cooperating with the International Vaccine Institute (IVI), a non-profit international organization in Eastern Europe and Southeast Asia, to apply for the IND approval for phase 3 clinical trials in other countries. The clinical trials in these regions will be conducted as early as next month.

Through the phase 3 clinical trial conducted in Korean and international medical facilities, SK bioscience will evaluate the immunogenicity and safety of GBP510. By securing interim data in the first half of the upcoming year, the company will also begin its preparations for obtaining the Pre-Qualification (PQ) certification from the World Health Organization (WHO) and Emergency Use Authorization (EUA) for other countries.

After the completion of its development, GBP510 is expected to help resolving the supply issues of COVID-19 vaccines in Korea. Currently, the country mostly relies on imports of COVID-19 vaccines.

Since GBP510 is developed and manufactured in domestic, the vaccine will ensure rapid responses to virus variants and contribute to securing vaccine sovereignty in Korea in long-run.

In addition, the synthetic antigen vaccine platform applied to GBP510 allows it to be stored in normal refrigeration conditions of 2 to 8 degrees Celsius. This will allow the vaccine to be distributed through the existing vaccine logistics networks with being stored for extended periods, leading to easier accessibility in worldwide.

GBP510 was the first vaccine candidate for the Wave2, an international project for supporting development of the next-generation COVID-19 vaccine. The project was initiated by the Coalition for Epidemic Preparedness Innovations(CEPI) last year. Upon completion of development, the vaccine will be supplied to millions worldwide through the COVAX Facility.

L HOUSE, SK bioscience’s vaccine manufacturing plant in Andong, is fully capable of conducting large-scale commercial production in millions of doses per year as soon as the vaccine is approved. The plant has 9 independent production units which are capable of manufacturing several types of vaccines simultaneously.

Jaeyong Ahn, CEO of SK bioscience, said, “With the prompt and systematic cooperation of health authorities and clinical organizations, we have successfully begun administrations to subjects in phase 3 clinical trial. By thoroughly verifying the vaccine’s safety and efficacy through the clinical trial, we will lay the groundwork for Koreans and all humankind to receive safe vaccinations.