SK Bioscience ready to embark on second vaccine's clinical trials

SEOUL -- SK Bioscience, a partner for South Korea's state project to develop COVID-19 vaccines, has applied for state approval to carry out clinical trials after its second vaccine candidate code-named GBP510 was selected to receive funding from an international foundation which finances vaccine research projects.

SK Bioscience hopes to embark on clinical trials in December to evaluate the safety and immunogenicity of GBP510, which is under development in a joint research project with the Institute for Protein Design at the University of Washington in Seattle. The vaccine candidate awaits approval from the Ministry of Food and Drug Safety.

"We are using our differentiated vaccine platform to discover a number of COVID-19 vaccine candidates and produce the best one," SK Bioscience CEO Ahn Jae-yong said in a statement on December 9. "Our goal is to create a COVID-19 vaccine with well-proven safety and effectiveness."

GBP510 has been selected for vaccine development by the Coalition for Epidemic Preparedness Innovations (CEPI), a foundation that takes donations to finance independent research projects to develop vaccines. It was the first case since CEPI launched its Wave 2 project in November to discover new vaccines with money from the Bill & Melinda Gates Foundation.

The Wave 2 project is aimed at finding universal and economical candidate materials that are easy to store and improve the number of inoculations, productivity and immune response. SK Bioscience will be able to receive $10 million from CEPI for clinical trials. If development is successful, the new vaccine will be distributed worldwide through international organizations.

SK Bioscience's first vaccine candidate called NBP2001 is in the first phase of clinical trials at a state-run hospital. NBP2001 is a recombinant vaccine manufactured from the virus' surface antigen protein through genetic combination. The surface antigen protein stimulates immune cells to induce immune responses.

SK Bioscience has promised to develop safe vaccines through the protein culture and refining platform of an antigen produced with gene recombination technology. The company has already succeeded in developing candidate substances for a cervical cancer vaccine through the same synthetic antigen method and completed second-stage clinical trials.

The Korea National Institute of Health, a state research body, has selected SK Bioscience as a cooperation partner to develop vaccines and medicine. SK Bioscience has a production partnership with AstraZeneca PLC, a Swedish-British pharmaceutical company which has announced positive results from late-stage trials of a coronavirus vaccine.

In August, SK Bioscience secured a deal to produce the antigen of a vaccine candidate being developed by Novavax, an American vaccine development company, that would be supplied in South Korea and globally if it proves to be safe and effective through clinical trials. Novavax is undergoing clinical trials for its vaccine candidate, NVX-CoV2373.