Sung Young-chul, CEO of Genexine (left), and Ji Young-mi, Director of the Korea Pasteur Institute, are exchanging a memorandum of understanding at Genexine headquarters in Pangyo, Gyeonggi Province. (Photo by Genexine)
[Asia Economy Reporter Kim Ji-hee] Genexine announced on the 12th that it will embark on a global clinical trial with the Korea Pasteur Institute to verify the efficacy of its COVID-19 vaccine candidate GX-19N against variant viruses.
Genexine plans to confirm the protective efficacy of GX-19N against COVID-19 variants through animal models. Based on this, the goal is to submit and obtain approval for global Phase 2/3 IND trials in regions where variants mainly occur, such as South Africa, through the Korea Pasteur Institute’s international network.
The Korea Pasteur Institute will establish a cooperative system with Genexine for overseas clinical trials of GX-19N by utilizing its existing overseas clinical trial design capabilities, the Pasteur Institute international network, and international collaborations such as the Global Virus Network (GVN). The Korea Pasteur Institute has discovered candidate drugs for COVID-19 treatment through drug repositioning and is currently conducting overseas clinical trials in Senegal, Mexico, Australia, and other countries.
According to Genexine, GX-19N incorporates the nucleocapsid antigen, which has high sequence conservation, in addition to the spike antigen of the COVID-19 virus, enabling it to respond not only to the original virus but also to variants. Genexine completed domestic Phase 1 clinical trials last February and has entered Phase 2a with 150 adult participants. Last month, it submitted an IND for Phase 2/3 clinical trials in Indonesia.
Sung Young-chul, Chairman of Genexine, stated, “With the support of the Korea Pasteur Institute, we have been able to proceed with clinical trials in regions where variants such as South Africa are emerging. Through the successful development of GX-19N, we will demonstrate preventive efficacy capable of responding not only to the existing COVID-19 virus but also to various variants.”
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