Jinwon Life Sciences Completes IND Application for Phase 1 Clinical Trial of 'SFTS Preventive DNA Vaccine' in Korea

Jinwon Life Sciences announced on the 9th that it has completed the submission of an Investigational New Drug (IND) application for the Phase 1 clinical trial of ‘GLS-5140,’ a DNA vaccine under development for the prevention of Severe Fever with Thrombocytopenia Syndrome (SFTS), to the Korea Ministry of Food and Drug Safety (MFDS).

The clinical trial submitted by Jinwon Life Sciences is titled “An open-label, intradermal multiple-dose, dose-escalation, and dose-finding Phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of the SFTS preventive DNA vaccine GLS-5140 in healthy adults.”

The SFTS preventive DNA vaccine was selected as a supported project under the Ministry of Health and Welfare’s Vaccine Commercialization Technology Development Program in the field of new vaccine development for future response to unresolved infectious diseases, receiving research and development funding up to the approval of the Phase 1 clinical trial. It was also previously selected as a supported project under the Ministry of Health and Welfare’s Infectious Disease Response Technology Development Program, successfully completing a preliminary feasibility study, the results of which were published in the internationally renowned journal Nature Communications, and domestic patent registration has been completed.

Park Young-geun, CEO of Jinwon Life Sciences, stated, “SFTS is a highly fatal infectious disease with no current treatment or vaccine available, and since there is no established treatment method, it mainly relies on supportive care, making prevention more important than anything else. We are very pleased to be the first in Korea to apply for a human clinical trial of an SFTS preventive DNA vaccine based on our company’s research and development capabilities in DNA vaccines for emerging and re-emerging infectious diseases.”

SFTS is a febrile hemorrhagic disease caused by the SFTS virus (SFTSV) and is a tick-borne zoonotic infectious disease. Since the first patient report in Korea in 2013, it has been designated and managed as a Class 3 notifiable infectious disease due to its high fatality rate. It mainly occurs in Korea, China, and Japan.

The World Health Organization (WHO) designated SFTS in 2017 as a disease requiring focused investment in research and development, and the UK Health Security Agency named SFTS as a high-risk infectious disease (HCID) that could pose the most lethal threat in the Republic of Korea as of January this year.

This content was produced with the assistance of AI translation services.