The new candidate COVID-19 vaccine ‘GX-1,’ which is being developed by the Korean biotech company Genexine, has been approved for phase 1 and 2a clinical trials in South Korea. It is the first time that a Korean company has obtained clinical trial approval for a COVID-19 vaccine from the Korean regulatory authority, and the second vaccine to win approval in Korea.
Genexine said on June 11 that GX-19 has been approved by the Korean Ministry of Food and Drug Safety for Phase 1 and Phase 2a clinical trials, and plans to complete the Phase 1 trial within 3 months. Genexine will evaluate the safety and efficacy of antibody formation in 150 patients, including the placebo group, in a single dose in phase 2a after conducting a phase 1 clinical trial in which two different volumes of the candidate vaccine will be administered to 40 adults.
GX-19 is a COVID-19 DNA vaccine being developed by a Genexine-led consortium including Binex, the International Vaccine Institute (IVI), GenNbio, KAIST, and POSTECH. DNA vaccines are designed to make antigens by first inserting nucleic acids into the body. The antigen then produces induced immune responses. This method is widely studied because it can be safe and quickly created when genomic information is available. The research team completed the development of the vaccine in March and has been preparing for clinical trials.