SK Bioscience, Clinical Trials Progressing Smoothly... 'Korea's First Domestic Vaccine' Nearly Ready (Comprehensive)

'GBP510' Phase 1 and 2 Clinical Trials Successful
99% Neutralizing Antibody Formation in Dosage Group
6 Times Higher Antibody Levels Compared to Recovered Patients 2 Weeks After Completion
No Serious Adverse Reactions Reported

Government "Plans to Pre-purchase 10 Million Doses of Domestic Vaccine"
Increased Likelihood of Selection

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

[Asia Economy Reporter Lee Chun-hee] SK Bioscience's COVID-19 vaccine under development has successfully completed clinical phases 1 and 2, signaling a green light for domestic vaccine development. Neutralizing antibodies were confirmed in over 99% of the vaccinated group, with no serious adverse reactions observed.

On the 5th, SK Bioscience announced that it confirmed positive immune responses and safety in the analysis results of clinical phases 1 and 2 of the COVID-19 vaccine candidate ‘GBP510,’ jointly developed with the Antigen Design Research Institute (IPD) at the University of Washington School of Pharmacy and utilizing GlaxoSmithKline (GSK)'s adjuvant technology.

SK Bioscience conducted clinical phases 1 and 2 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 together, 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) compared to the serum panel of recovered COVID-19 patients in the overall clinical group analysis. In the plaque reduction neutralization test (PRNT) analysis conducted on some groups, the result was 3.6 times higher. The enzyme-linked immunosorbent assay (ELISA) also showed binding antibody titers approximately 13.3 times higher than the serum panel of recovered patients.

An SK Bioscience official said, "Despite including elderly people aged 65 and over, who generally have weaker immune responses, GBP510 showed similar or superior immunogenicity compared to existing COVID-19 vaccines, with high levels of neutralizing antibody induction confirmed in clinical phases 1 and 2." 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 serum of recovered patients included all levels from the lowest to the highest neutralizing antibody formation rates. In terms of safety, no serious adverse reactions related to GBP510 administration occurred, confirming sufficient tolerability.

Although there were concerns about entering clinical phase 3 without fully completing phases 1 and 2, these were successfully overcome. SK Bioscience began clinical phase 3 in August at 14 domestic clinical institutions including Korea University Guro Hospital. Currently, over 500 people have been vaccinated. The immunogenicity and safety of GBP510 are being evaluated through a comparative clinical trial with the AstraZeneca vaccine.

In addition, clinical trials are underway in Vietnam, and country-specific approvals for multinational phase 3 clinical trials in Europe and Southeast Asia are also in progress. Based on clinical phase 3 data involving about 4,000 participants, SK Bioscience plans to obtain rapid approval from domestic health authorities for GBP510 in the first half of next year, acquire WHO prequalification (PQ) certification, and secure emergency use authorizations from overseas countries.

The possibility of being selected as a domestic vaccine for government pre-purchase has also increased. Currently, the government plans to pre-purchase domestic COVID-19 vaccines comprehensively considering efficacy and safety, based on interim results of clinical phase 2 and entry into phase 3. The government has already secured 72 billion KRW as an advance payment in this year's supplementary budget and plans to allocate 192 billion KRW next year to purchase 10 million doses of domestic vaccines.

SK Bioscience CEO Ahn Jae-yong said, "The successful completion of clinical phases 1 and 2 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, Korea Disease Control and Prevention Agency, as well as global organizations and companies including the Coalition for Epidemic Preparedness Innovations (CEPI), Bill & Melinda Gates Foundation, International Vaccine Institute (IVI), and GSK." He added, "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."

Having successfully completed clinical phases 1 and 2 and with phase 3 underway, SK Bioscience is currently considered the most advanced domestic COVID-19 vaccine developer. Additionally, Genexine, another domestic vaccine developer, has applied for and is awaiting approval for global clinical phases 2 and 3, while Cellid plans to submit clinical phase 2b and 3 trial plans soon.

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