SK Bioscience, "Successful Phase 1/2 Clinical Trial of Domestic COVID-19 Vaccine"... 99% Neutralizing Antibodies Confirmed

SK Bioscience 'L House Vaccine Center' in Andong-si, Gyeongbuk (Photo by SK Bioscience)

[Asia Economy Reporter Lee Chun-hee] SK Bioscience's domestically developed COVID-19 vaccine candidate has shown promising results in its Phase 1/2 clinical trials. Neutralizing antibodies were confirmed in over 99% of the vaccinated group, with no serious adverse reactions reported.

On the 5th, SK Bioscience announced that it confirmed positive immune responses and safety in the Phase 1/2 clinical trial analysis of the COVID-19 vaccine candidate 'GBP510,' which was co-developed with the Antigen Design Research Institute (IPD) at the University of Washington School of Pharmacy and utilized GlaxoSmithKline (GSK)'s adjuvant technology.

SK Bioscience conducted the Phase 1/2 clinical trial administering GBP510 to 328 healthy adults at 14 institutions, including Korea University Guro Hospital. The results showed that over 99% of the vaccinated group who received the adjuvant developed neutralizing antibodies that neutralize the COVID-19 virus.

The level of neutralizing antibody induction two weeks after completing vaccination was about six times higher in the pseudovirus-based neutralization assay (PBNA) analysis of the entire clinical group compared to the serum panel of COVID-19 convalescent patients. In the plaque reduction neutralization test (PRNT) analysis conducted on some groups, the results were 3.6 times higher. The enzyme-linked immunosorbent assay (ELISA) results also showed binding antibody titers approximately 13.3 times higher than the convalescent serum panel.

An SK Bioscience official stated, "Despite including elderly individuals aged 65 and older, who generally have weaker immune responses, GBP510 demonstrated similar or superior immunogenicity compared to existing COVID-19 vaccines, as confirmed by the high level of neutralizing antibody induction in the Phase 1/2 trial results."

This clinical trial used evaluation methods based on international standard materials established by the World Health Organization (WHO) and the National Institute for Biological Standards and Control (NIBSC) in the UK. The convalescent serum included a range from the lowest to the highest levels of neutralizing antibody formation.

Regarding safety, no serious adverse reactions related to GBP510 administration were reported, confirming sufficient tolerability.

In August, subject administration for the Phase 3 clinical trial of SK Bioscience's COVID-19 vaccine candidate 'GBP510' was conducted at Dong-A University Hospital in Busan. (Photo by SK Bioscience)

SK Bioscience plans to submit these Phase 1/2 clinical trial results to domestic and international health authorities while accelerating the development of GBP510. Currently, SK Bioscience is seeking country-specific approvals for multinational Phase 3 clinical trials in Europe and Southeast Asia in collaboration with the International Vaccine Institute (IVI). In South Korea, Phase 3 trials began in August at 14 clinical institutions, including Korea University Guro Hospital, with dosing completed for about 500 participants. Clinical trials are also underway in Vietnam.

Based on Phase 3 clinical data from approximately 4,000 participants, SK Bioscience aims to obtain expedited approval for GBP510 from domestic health authorities in the first half of next year, as well as prequalification (PQ) certification from WHO and emergency use authorizations from overseas countries.

Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), which has been involved since the early development stages of GBP510, said, "The Phase 1/2 clinical trial results of SK Bioscience's COVID-19 vaccine are very encouraging. To strengthen COVID-19 control efforts, CEPI will continue its collaboration with SK Bioscience and South Korea."

Ahn Jae-yong, President of SK Bioscience, said, "The successful completion of the Phase 1/2 trials was possible thanks to close cooperation with domestic health authorities such as the Pan-Government Support Committee, Ministry of Health and Welfare, Ministry of Food and Drug Safety, and Korea Disease Control and Prevention Agency, as well as global organizations and companies including CEPI, the Gates Foundation, IVI, and GSK. With Phase 3 progressing smoothly, we will quickly complete the development of GBP510 to contribute to overcoming the pandemic and securing the health rights of humanity."

This content was produced with the assistance of AI translation services.