Korea's first Covid vaccine candidate generates promising trial results
SK Bioscience’s Covid-19 vaccine candidate demonstrated statistically meaningful results confirming safety and immunogenicity in Phase 1 and 2 clinical trials.
On Friday, the Korean vaccine maker shared top line results of Phase 1 and 2 clinical trials of GBP510, a Covid-19 vaccine candidate currently undergoing Phase 3 clinical trials globally.
According to the results, about 99 percent of patients who were administrated with GBP510 produced antibodies neutralizing the coronavirus. A total of 328 healthy adults participated in the two rounds of trials conducted locally in 14 hospitals.
SK Bioscience also said virus neutralizing antibodies were between 3.6 times and six times higher in patients 14 days after administration of GBP510 compared to the patients who were fully recovered after infected with the coronavirus.
The candidate also showed high immunogenicity among patients 65 or older, those who are likely to have weaker immune response.
In regard to safety, no patients experienced notable side effects, according to SK Bioscience.
The vaccine maker plans to submit the results to domestic and overseas health authorities and accelerate Phase 3 clinical trials — the last round required for a vaccine.
“We were able to successfully conclude Phase 1 and 2 clinical trials because of the close cooperation with local health authorities, including the Ministry of Health and Welfare, Ministry of Food and Drug Safety and the Korea Disease Control and Prevention Agency, as well as international organizations like the Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation and the International Vaccine Institute (IVI),” said Ahn Jae-yong, CEO of SK Bioscience, in a statement. “We will contribute to overcoming the pandemic and securing people’s rights of healthcare by quickly concluding the development of GBP510."
Co-developed with the University of Washington’s Institute for Protein Design, GBP510 has received the nod to start Phase 3 trials in Korea and Vietnam. The company aims to conduct the trials in a total of five foreign countries and has been waiting for approvals from New Zealand, Ukraine, Philippines and Thailand. SK Bioscience is conducting trials in Korea, and IVI is running trials for the company outside of Korea.
The company believes it will gain approvals from all countries as early as the end of the month.
Phase 3 clinical trials will be conducted on 3,990 people aged 18 or older. A total of 3,000 people will be injected with SK Bioscience’s GBP510, while 990 will get AstraZeneca vaccines, in order to compare the immunogenicity of an already authorized vaccine with the candidate under development in order to prove its efficacy. They will receive two doses of 0.5 milliliters (0.017 ounces) at four-week intervals. SK Bioscience already finished administrating the candidate on 500 Korean patients in August.
The company aims to release the interim results of the Phase 3 clinical trials by the first quarter of next year and, if the results are good, start marketing the vaccine within the first half.
Demand for Covid-19 vaccines is still high, SK Bioscience said, as only 50 percent of the world’s population has received at least the first dose of a vaccine as of Nov. 4. In developing countries, the vaccination rate is 3.9 percent, according to data from Oxford University's statistics system.
BY SARAH CHEA [firstname.lastname@example.org]