SK Bioscience said Friday that its Covid-19 vaccine candidate has shown excellent outcomes in phase 1 and 2 clinical trials.
As the company has analyzed the results of previous clinical trials of its Covid-19 vaccine candidate and the ongoing phase 3 clinical trials, it expects to present the first home-grown vaccine soon.
SK Bioscience developed it with the University of Washington's Institute for Protein Design. It used GSK's adjuvants in the clinical trials of its Covid-19 vaccine candidate called GBP510, confirming positive immune response and safety profile from the phase 2 studies.
The company conducted phase 1 and 2 clinical trials of GBP510 on 328 healthy adults at 14 institutions, including Korea University Guro Hospital, and found that more than 99 percent of the participants administered with the immune booster formed antibody and neutralized the Covid-19 virus.
Researchers assessed the clinical data according to the evaluation standard provided by the World Health Organization and the U.K. National Institute for Biological Standards and Control (NIBSC), measuring how the antibody formed in the serum collected from recovered patients.
In terms of safety, the company said the vaccine candidate showed good tolerability without serious adverse reactions.
SK Bioscience is working with the International Vaccine Institute (IVI) to receive regulatory approval from Europe and Southeast Asia to conduct phase 3 clinical trials of GBP510, following the ongoing study in Vietnam.
Based on the data obtained from the phase 3 clinical trials with about 4,000 people, the company plans to acquire authorization from the domestic health authorities for GBP510 in the first half of 2022 and later receive WHO's pre-qualification and emergency use approval in other nations.
In addition to the vaccines brought in from the COVAX facility, SK Bioscience plans to supply GBP510 to the world after receiving approval in each country.
"The results of SK Bioscience's GBP510 derived from the phase 1 and 2 clinical trials are quite promising," Coalition for Epidemic Preparedness Innovations (CEPI) CEO Richard Hatchett said, "Continuous global investment for the development of the next-generation Covid-19 vaccine is essential, and CEPI will cooperate with SK Bioscience and Korea to control Covid-19 pandemic."
SK Bioscience CEO Ahn Jae-yong also said, "We carried out the first part of the clinical trials successfully thanks to close cooperation with health authorities, organizations, and companies like GSK, CEPI, Gates Foundation, and IVI."