Jinwon Life Sciences Applies for US FDA Clinical Approval for Global Development of COVID-19 Vaccine

[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 19th that it has completed the pre-IND procedure with the U.S. Food and Drug Administration (FDA) for the novel coronavirus disease (COVID-19) vaccine GLS-5310 and has submitted an application for clinical trial approval to conduct clinical research in the United States.

GeneOne Life Science plans to verify the superiority of the intradermal injection method, which is convenient for administration and easy for mass production, applied in domestic clinical trials through clinical research in the U.S. To achieve more complete prevention of COVID-19 infectious disease, the company intends to evaluate the efficacy of combining intradermal injection and intranasal spray administration of GLS-5310, and then use the results to select the optimal vaccine administration conditions for late-stage clinical trials.

A company official explained, “Animal experiments using rabbits showed that intradermal injection of GLS-5310 alone induced IgA antibody production, but when intranasal administration and intradermal injection were combined, a large amount of IgA antibody production was confirmed.”

According to domestic and international research results, intranasal vaccine administration is considered important because it induces mucosal IgA immune responses that suppress infection in the nasal area, the initial entry point of the COVID-19 virus. Furthermore, viral infection in the nasal area not only moves to the lungs causing infection but also spreads to others, leading to transmission. Therefore, simultaneously suppressing nasal infection through vaccination can be expected to achieve the efficacy of an ideal vaccine.

Park Younggeun, CEO of GeneOne Life Science, stated, “Our company has a robust product portfolio to respond to COVID-19 infectious disease. The COVID-19 vaccine GLS-5310 is scheduled to undergo clinical trials not only in Korea but also in the U.S. Recently, GLS-1200, a COVID-19 virus infection prevention nasal spray treatment that showed positive results through evaluation in a ferret infection animal model, is conducting Phase 2 clinical trials in the U.S. Additionally, GLS-1027, an immunomodulatory drug that suppresses the cytokine storm causing severe COVID-19 infection, has received approval for Phase 2 clinical trials in the U.S. and is under development,” he said.