Recruitment of global Phase III clinical trial of ‘GBP510’ completed, with vaccine expected to be authorized in the first half of 2022
Company simultaneously conducts a booster trial, aiming to provide a new alternative in the global COVID-19 vaccine market

SK bioscience (CEO Jae-Yong Ahn) announced on January 18 that the company has completed the recruitment of participants for the Phase III clinical trial of ´GBP510´, a COVID-19 vaccine candidate. The Phase 3 clinical trial is the final stage of development to verify the safety and efficacy of the vaccine.

The participants in the Phase III clinical trial of GBP510 are 4,037 adults aged 18 and older, including about 570 people in Korea and 3,467 in five other countries in Europe, Southeast Asia, and Oceania. Clinical trials in Korea are now being conducted in cooperation with 16 domestic institutions, including Korea University Guro Hospital. Global clinical trials are being carried out in cooperation with the International Vaccine Institute (IVI), a non-profit international organization.

The second dose administration in Korea has been completed after SK bioscience began administering the first dose in subjects in the Phase III trial in August 2021. Clinical samples from domestic participants are currently in the efficacy evaluation stage to measure the level of antibodies that neutralize viruses by the National Institute of Health (NIH) under the Korea Disease Control and Prevention Agency (KDCA).

Now that the recruitment for the trial has been completed, the NIH and IVI are also sequentially receiving and analyzing samples from overseas. SK bioscience plans to rapidly complete the Phase III clinical trial and secure efficacy and safety data .

SK bioscience is also conducting clinical trials of GBP510 as a booster vaccine to respond to various variants. SK bioscience is conducting two separate booster clinical trials with different subjects to verify the vaccine’s safety and efficacy. Subjects who participated in the Phase I/II clinical trials of GBP510, will receive an additional shot 6 months after the initial shots in this trial conducted by SK bioscience. About 550 subjects who received other COVID-19 vaccines initially, will receive GBP510 in this study coordinated by the KDCA.

Furthermore, SK bioscience is also preparing to conduct a clinical trial in children and adolescents.

Based on the results of the Phase III and booster clinical trials, SK bioscience will submit applications for WHO PQ (Pre-qualification) certification and emergency use authorization of GBP510 by each country. GBP510 was the first COVID-19 vaccine candidate to beed as a part of Wave 2, a project initiated by the Coalition for Epidemic Preparedness Innovations (CEPI) in 2020 to support promising vaccine candidates. Once licensed, hundreds of millions of GBP510 will be made available to the COVAX Facility for procurement and equitable allocation worldwide. GBP510 is expected to be a new alternative tool in the fight to end the ongoing pandemic.

GBP510 is a recombinant protein-based COVID-19 vaccine candidate jointly developed with the Institute for Protein Design (IPD) at School of Medicine, the University of Washington, combined with GlaxoSmithKline (GSK)´s pandemic adjuvant.

The recombinant protein platform utilized to GBP510, has been also used for development of current influenza (flu), hepatitis B, and cervical cancer vaccines in long term, for example. The vaccine is expected to contribute to increasing the global vaccination rate including underdeveloped countries with relatively easier distribution method, as it can be stored in normal refrigeration conditions from 2 to 8 degrees Celsius and create a market differentiated by inducing inoculation to people who are reluctant to take currently authorized COVID-19 vaccines.

According to Our World in Data, a statistical website at Oxford University in the UK, 59.3% of the global population have received one or more doses of the COVID-19 vaccine, but only 8.9% in underdeveloped countries have received one or more doses, so the global demand for the vaccine is still high.

Also, the US Centers for Disease Control and Prevention (CDC) recently approved the fourth shot of COVID-19 vaccines as booster since the Delta and Omicron variants are occurring.

Jae-Yong Ahn, CEO of SK bioscience said, "Vaccines are the best way to protect not only individuals but also the society in this long COVID-19 pandemic situation. "We will try our best to ensure that a Korean vaccine can contribute to overcoming the long dark pandemic tunnel by successfully completing the development of GBP510.”