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Genexine, COVID-19 preventive vaccine, GX-19, clinical 1/2 phase approval

- The first domestic pharmaceutical company entered the clinical trial of COVID-19 in Korea
- Approval of IND within 3months of starting development via quick review of MFDS
- Planned to complete phase 1 within 3months and expand to multi-country clinical trials including COVID-19 endemic countries fro the phase 2a of clinical trial
 
Genexine(CEO, Young Chul Sung) said 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 be proceeded 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 of departure.


The phase 1 of clinical trials will be completed within 3 months, and the phase 2 phase 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."


Genexine is currently the only company that simultaneously develops preventive vaccines and treatments for COVID-19 by collaborating with NIT and approved US clinical trials of Hyleukin-7 for COVID-19 patients. It is one of three vaccine development companies supported by the government Korea.