SK Bioscience Applies for Domestic Phase 3 Clinical Trial of COVID-19 Vaccine 'GBP510' Booster Shot

Clinical Trials Ongoing for 750 Participants Receiving 1st and 2nd Doses... Cross-Vaccination Studies Underway
Effectiveness Against Omicron and Other Variants Confirmed; Clinical Plans for Adolescents Announced

SK Bioscience Andong L House.

[Asia Economy Reporter Lee Gwan-ju] SK Bioscience is expanding the indications for its COVID-19 vaccine candidate 'GBP510.' Along with the commercialization of the first domestically produced vaccine in the first half of the year, the plan is to broaden its use to include booster shots and adolescents.

On the 22nd, SK Bioscience announced that it had submitted a clinical trial plan (IND) for a Phase 3 booster shot of GBP510 to the Ministry of Food and Drug Safety.

GBP510 is a synthetic antigen vaccine candidate jointly developed by SK Bioscience, supported by the Coalition for Epidemic Preparedness Innovations (CEPI), and the Institute for Protein Design (IPD) at the University of Washington School of Pharmacy. GlaxoSmithKline (GSK)'s adjuvant 'AS03' was utilized in the vaccine.

This booster shot clinical trial targets 750 adults aged 18 and older who participated in the Phase 3 trial of GBP510. The booster will be administered once at least three months after completing the initial dosing in the Phase 3 trial. Safety and immunogenicity will be evaluated at 16 domestic clinical institutions, including Korea University Guro Hospital, as well as overseas institutions.

Additionally, a booster shot clinical trial involving heterologous administration of GBP510 is underway for adults who have completed their primary vaccination series with other COVID-19 vaccines already approved in Korea. This heterologous booster trial, conducted by nine domestic institutions under the leadership of the Korea Disease Control and Prevention Agency (KDCA) as an investigator-initiated study, began dosing approximately 550 adults aged 19 to under 50 after receiving IND approval from the Korean MFDS in December last year.

Preparations have also begun for a clinical trial of GBP510 targeting adolescents, aiming to enter Phase 3 within the first half of the year. Furthermore, research is ongoing to verify the preventive efficacy of GBP510 against COVID-19 variants such as Omicron, and to build a platform using GBP510 development technology to respond to the 'Next Pandemic' era. Recently, an expanded study was initiated after confirming that a booster shot in participants of the GBP510 Phase 1/2 trials showed preventive effects against Omicron. In addition, in collaboration with CEPI, SK Bioscience has embarked on developing vaccines targeting 'sarbecovirus,' which includes COVID-19, Severe Acute Respiratory Syndrome (SARS), and related variants.

SK Bioscience plans to promptly pursue domestic product approval, World Health Organization Emergency Use Listing (EUL), and emergency use authorizations in various countries as multiple GBP510-related clinical trials conclude. Ahn Jae-yong, CEO of SK Bioscience, stated, "We will expand the applications of GBP510 and establish it as a platform to proactively prepare for the next pandemic. As our vaccine technology has grown to a level recognized worldwide, we will expand our business into various fields and grow into a leading global vaccine company."

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