24 June 2020 | News
Plan to complete phase 1 within 3 months and expand to multi-country clinical trials
Image credit- shutterstock.com
South Korea based Genexine has announced that it is the first domestic pharmaceutical company to have been approved for clinical phase 1/2a of GX-19, which is a DNA vaccine against COVID-19, by the Ministry of Food and Drug Safety.
This trial will proceed phase 1 for 40 healty volunteers in two dose level and evaluate the safety and efficacy of antibody formation in 150 patients, including placebo, in one dose in phase 2a.
On March 13th, Genexine started the development of GX-19 by forming the COVID-19 DNA vaccine development consortium (Genexin, Binex, International Vaccine Institute, GeNBio, KAIST, and POSTECH).
As a result of the close collaboration of the consortium members and the rapid evaluation of the Ministry of Food and Drug Safety, the clinical trial was approved within 3 months.
The phase 1 of clinical trials will be completed within 3 months, and the phase 2 of clinical trials will be expanded to multinational clinical trials, including countries where the spread of COVID-19 is severe in the second half of this year.
Young Chul Sung, CEO, said, "We are working with several domestic and foreign partners including Binex to secure vaccine supply, and we will accelerate our preparations to supply sufficient amounts not only in Korea but also in countries with insufficient vaccines."