SK Bioscience has started administering Covid-19 vaccine candidate GBP510, jointly developed with the Institute for Protein Design (IPD) at the University of Washington, in phase 3 clinical trials.
The company’s clinical trials are the first domestic phase 3 study of the Covid-19 vaccine approved by the Ministry of Food and Drug Safety on August 10.
The phase 3 clinical trials of GBP510 will be conducted at 14 domestic institutions, including Korea University Guro Hospital and overseas institutions in Europe and Southeast Asia, targeting 4,000 domestic and foreign adults older than 18.
SK Bioscience combined GBP510 with GSK’s pandemic adjuvant system and administered them twice at a 28-day interval.
The company is also working with the International Vaccine Institute (IVI), a non-profit organization, to apply for conducting phase 3 clinical trials in other countries in Eastern Europe and Southeast Asia. It plans to start clinical trials overseas as early as next month.
SK Bioscience plans to secure interim data in the first half of 2022 by evaluating the immunogenicity and safety of GBP510 from multinational studies. It also expects to receive accelerated approval from the domestic health authorities and prequalification from the World Health Organization and prepare for emergency use authorization in other countries.
In the first stage of phase 1/2 study conducted in institutions including Korea University Guro Hospital, all 80 healthy adult participants generated antibodies neutralizing the Covid-19 virus after receiving the adjuvanted GBP510 vaccine.
The observed neutralizing antibody titer was also five to eight times higher than the serum of recovered Covid-19 patients, a value measured based on international standards and assessments established by WHO and the U.K. National Institute for Biological Standards and Control (NIBSC).
No severe adverse events were detected after taking the GBP510 injection, demonstrating sufficient tolerability. SK bioscience has also completed the second dose for 247 people, including the elderly, in the second stage of the study and follows up to check for safety issues.
The company expected the development of GBP510 to resolve the vaccine shortage Korea has constantly been facing.
If GBP510 successfully obtains approval from domestic health authorities, the company will establish and supply its production and supply plan of the homegrown vaccine. The company can quickly respond to variants based on its original platform technology in terms of vaccine sovereignty.
The synthetic antigen vaccine platform applied to GBP510 can be stored between two to eight degrees Celsius, which allows the company to supply the vaccine with the existing distribution network.
SK Bioscience has a plant in Andong, North Gyeongsang Province, which can immediately begin mass production of hundreds of millions of doses per year and manufacture different vaccines in its nine separated suites.
“We have successfully begun administering GBP510 to subjects in phase 3 clinical trials under the prompt and systematic cooperation with health authorities and clinical institutions,” SK Bioscience Ahn Jae-yong said. “We will prepare a basis for Koreans and all others worldwide to vaccinate with confidence by thoroughly verifying safety and efficacy through the studies.”