4,000 Adults at Home and Abroad Enroll in Clinical Trials
SK Bioscience announced on Aug. 30 that it has started administering the COVID-19 vaccine candidate "GBP510" to the first subjects in its phase 3 clinical trial. The company jointly developed the candidate drug with the Institute of Protein Design (IPD) at the University of Washington. This is the first clinical phase 3 administration of a COVID-19 vaccine candidate developed in Korea. It came three weeks after the Ministry of Food and Drug Safety approved the company’s investigational new drug (IND) application.
The phase 3 clinical trial of GBP510 will be conducted at 14 domestic institutions, including Korea University Guro Hospital, for 4,000 Korean and foreign adults over the age of 18 in Europe and Southeast Asia. GBP510 is a synthetic antigen vaccine created through genetic recombination technology. It is mixed with GSK's immune booster and injected twice 28 days apart.
SK Bioscience is filing a clinical phase 3 IND application with countries in Eastern Europe and Southeast Asia in cooperation with the International Vaccine Research Institute (IVI), a non-profit international organization. It plans to start clinical trials as early as next month.
SK Bioscience plans to evaluate the immunogenicity and safety of GBP510 through phase 3 clinical trials at home and abroad and secure interim data in the first half of next year. Then it will obtain quick permission from Korean health authorities and will take steps to have it certified by the WHO, and prepare for emergency use permission by countries.
When the development of GBP510 is completed, it is expected to ease a vaccine shortage in Korea, which relies on imported vaccines. GBP510 can be stored under refrigerating conditions of two to eight degrees Celsius, so it can be distributed using current vaccine supply networks and stored for a long time.
GBP510 was selected as the first beneficiary of Wave 2, which was launched by the Coalition for Epidemic Preparedness Innovations (CEPI) in 2020 to support development of differentiated COVID-19 vaccine candidates. Hundreds of millions of doses will be supplied throughout the world including Korea through COVAX facilities once its development is wrapped up. SK Bioscience' vaccine factory in Andong, North Gyeongsang Province, has the capacity to commercially produce hundreds of millions of vaccine doses a year and has independent spaces in its plant to manufacture various types of vaccines simultaneously.