SK Bioscience to kick off phase 3 vaccine trials

SK Bioscience Co. has received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for phase 3 clinical trials of its COVID-19 vaccine candidate GBP510, according to the company on Aug. 10. SK Bioscience targets commercializing the vaccine within the first half of 2022.

The domestic part of the third phase trial will be conducted at 13 medical institutions in South Korea including Korea University’s Guro Hospital. A total of 4,000 adults will each receive two shots of GBP510.

The global part will be conducted in partnership with the International Vaccine Institute (IVI) in multiple countries in Europe and Southeast Asia. Based on the results of the multi-regional clinical trials, SK Bioscience will apply for the World Health Organization’s prequalification (PQ) program and prepare to file for emergency use approval in a number of countries.

SK Bioscience said it also signed a trilateral agreement recently with the IVI and the National Institute of Health (NIH) to co-analyze the results of the phase 3 trials. The company added that it expects the accuracy and the speed of the analysis to improve greatly with the help of the IVI and the NIH.

SK Bioscience added that it completed injecting the second dose of the GBP510 vaccine to a total of 247 participants, including the elderly, of its phase 2 trials by the end of June this year. The company said that there has not been any safety issue with GBP510 to date.

Experts say that GBP510’s key advantage over vaccines already being distributed worldwide is its ability to be stored at much higher temperatures. It can be stored and distributed at 2-8°C, meaning that it can be used in remote regions and countries where ultra-low temperature freezers are not available.

SK Bioscience’s vaccine candidate GBP510, jointly developed with the Institute for Protein Design at the University of Washington, is funded by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).

Of the total $213.7 million funded by the two organizations, SK Bioscience said $173 million will be used for research and development of the COVID-19 vaccine, including the phase 3 trials. The company added that the funds are also used for supporting regulatory activities, purchase of raw materials and additional R&D initiatives in response to COVID-19 variants.

Write to In-hyuk Park at hyuk@hankyung.com
Daniel Cho edited this article.