SK Bioscience said its Covid-19 vaccine candidate GBP510 has recently received approval from the Vietnamese government to run phase 3 clinical trials, speeding up the development through global studies in five countries.

SK Bioscience’s Covid-19 vaccine candidate GBP510 has recently received approval in Vietnam to conduct phase 3 clinical trials.
SK Bioscience’s Covid-19 vaccine candidate GBP510 has recently received approval in Vietnam to conduct phase 3 clinical trials.

The International Vaccine Institute (IVI), collaborating with SK Bioscience for the Covid-19 vaccine development, recently won approval to conduct a phase 3 clinical trial for GBP510 in Vietnam.

SK Bioscience and IVI plan to conduct phase 3 clinical trials in five countries, including New Zealand, Ukraine, the Philippines, and Thailand. The recent approval received from Vietnam completes the fifth country, and the two partners are taking steps to run the studies.

Earlier, the company said it would conduct phase 3 clinical trials in Europe and Southeast Asia with IVI but did not name countries. SK Bioscience leads the domestic phase 3 clinical trial, and IVI leads the overseas trials.

GBP510 is a Covid-19 vaccine candidate developed jointly by SK Bioscience with the Institute for Protein Design (IPD) of the University of Washington, U.S. The company began administering the vaccine candidate in Korea in late August. Developers made the drug candidate using genetic recombination technology. It induces an immune response by injecting the surface antigen protein of the Covid-19 virus into the human body.

They tested the candidate for its safety and immunogenic response in adjuvant with GSK’s AS03 and produced promising interim data in phase 1 and 2 clinical trials.

GBP510 is also a candidate for the next-generation Covid-19 vaccine first designated by the Coalition for Epidemic Preparedness Innovations (CEPI). The global coalition has funded the phase 3 study.

SK Bioscience, IVI, and the Korea National Institute of Health (NIH) under the Korea Disease Control and Prevention Agency (KDCA) have recently signed an agreement to conduct antibody testing for the joint global phase 3 trials.

SK Bioscience plans to secure phase 3 study data in early 2022 and apply for emergency use authorization from countries, including Korea.

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