SK Bioscience's COVID-19 Vaccine 'GBP510' Enters Phase 3 Clinical Trial Administration

On the 30th, at Dong-A University Hospital in Busan, the administration of the COVID-19 vaccine candidate 'GBP510' by SK Bioscience for the Phase 3 clinical trial is underway. (Photo by SK Bioscience)

[Asia Economy Reporter Lee Chun-hee] The Phase 3 clinical trial of the COVID-19 vaccine 'GBP510' developed by SK Bioscience has officially begun.

SK Bioscience announced on the 30th that it has started the first subject administration in the Phase 3 clinical trial of the synthetic antigen COVID-19 vaccine candidate ‘GBP510’, jointly developed with the Institute for Protein Design (IPD) at the University of Washington in the United States. This is about three weeks after the approval of the clinical trial plan (IND) by the Ministry of Food and Drug Safety, marking the first Phase 3 administration among domestically developed COVID-19 vaccine candidates.

The Phase 3 trial of GBP510 involves intramuscular administration twice at 28-day intervals of the synthetic antigen vaccine GBP510, produced using recombinant technology, mixed with GlaxoSmithKline (GSK)’s pandemic adjuvant. It is planned to be conducted on approximately 4,000 adults aged 18 and over both domestically and internationally. In addition to 14 domestic institutions including Korea University Guro Hospital, applications for IND approval for Phase 3 clinical trials are being submitted in each country overseas, including Europe and Southeast Asia, in collaboration with the nonprofit international organization International Vaccine Institute (IVI).

Through this Phase 3 trial, SK Bioscience plans to evaluate the immunogenicity and safety of GBP510, secure interim data by the first half of next year, and obtain expedited approval from domestic health authorities. The company will also begin preparations to acquire the World Health Organization (WHO)’s prequalification (PQ) certification and emergency use authorizations from various countries.

Previously, SK Bioscience confirmed that in Stage 1 of the Phase 1/2 clinical trial involving 80 healthy adults who received GBP510 together with the adjuvant, 100% of subjects developed neutralizing antibodies that neutralize the COVID-19 virus. The level of neutralizing antibody induction was between 5 to over 8 times higher compared to the serum panel of recovered COVID-19 patients. These results were measured using international standard materials and evaluation methods established by WHO and the UK National Institute for Biological Standards and Control (NIBSC).

Regarding safety, no serious adverse reactions related to GBP510 administration have occurred. In Stage 2, which is currently ongoing and includes elderly participants, all 247 subjects who have completed administration and are under safety follow-up have shown no particular safety issues to date.

SK Bioscience Factory 'L House' in Andong-si, Gyeongbuk [Image source=Yonhap News]

If the development of GBP510 is successful, it is expected to greatly assist the domestic supply of COVID-19 vaccines, which currently depends on imports from overseas. As a domestically produced vaccine, it allows for independent production and supply, and in the long term, it will secure platform technology capable of rapidly responding to variant viruses.

In particular, the synthetic antigen vaccine platform of GBP510 can be stored under refrigerated conditions at 2 to 8 degrees Celsius, enabling distribution using existing vaccine logistics networks and facilitating long-term storage. This will improve vaccine accessibility in overseas countries facing difficulties with the 'cold chain' (frozen distribution). GBP510 was selected as the first candidate for the 'Wave 2' project launched by the Coalition for Epidemic Preparedness Innovations (CEPI) to develop next-generation COVID-19 vaccines. Upon completion, hundreds of millions of doses are expected to be supplied worldwide through the global vaccine procurement alliance, the COVAX facility.

An Jae-yong, CEO of SK Bioscience, said, "With the rapid and systematic cooperation of health authorities and clinical institutions, we have begun successful Phase 3 subject administration,” adding, “Through the clinical trial, we will thoroughly verify safety and efficacy to establish a foundation that allows the people of the Republic of Korea and, furthermore, all humanity to receive the vaccine with confidence.

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