Genexine announced on December 19 that it is resubmitting its application for clinical trial approval of GLS-5140, a vaccine candidate for the prevention of severe fever with thrombocytopenia syndrome (SFTS), with the goal of obtaining IND approval from the Ministry of Food and Drug Safety and entering clinical trials by 2026.
The company stated, "Since the launch of the new management team, the most urgent task has been to continue research and development (R&D), which is the core of our corporate identity, without interruption. This is essential for restoring and enhancing corporate value. As the first priority, we have decided to focus on the development of GLS-5140, which previously failed to obtain clinical approval due to funding issues and lack of additional supplementation."
GLS-5140 is a nucleic acid-based vaccine candidate designed to prevent SFTS, a disease known as 'killer tick infection.' It targets high-risk, emerging, and re-emerging infectious diseases for which no commercialized vaccines are currently available either domestically or internationally. As SFTS has a high fatality rate and limited treatment options, Korean health authorities also recognize it as an infectious disease that requires a national-level public health response.
In fact, the government views the development of public vaccines and the establishment of proactive response capabilities for new and variant infectious diseases, including SFTS, as key policy tasks. It is seeking to connect research and development, clinical trials, and future procurement through collaboration with private companies. In line with these policy directions, Genexine is actively considering the possibility of cooperating with the Korea Disease Control and Prevention Agency to develop GLS-5140 as a public vaccine.
The company particularly emphasized that there is already sufficient scientific evidence supporting GLS-5140. The vaccine candidate demonstrated excellent preventive efficacy in animal model studies, and related research findings have been published in the internationally renowned journal Nature Communications. The company explained that this shows GLS-5140 possesses substantial data as a candidate for clinical entry.
Genexine plans to systematically pursue the following steps by 2026: finalizing the supplementary requirements for the existing IND, conducting any necessary additional non-clinical studies, holding pre-IND meetings with the Ministry of Food and Drug Safety and submitting the IND application, and obtaining approval for phase 1/2a clinical trials. Through these efforts, the company aims to establish itself as a leading developer of SFTS preventive vaccines in Korea.
A company representative said, "GLS-5140 is a symbolic project that demonstrates Genexine's return to being a research and development-driven company. We will responsibly develop vaccines with significant public health needs and, through collaboration with public agencies such as the Korea Disease Control and Prevention Agency, contribute to strengthening the national capacity to respond to infectious diseases."
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