Jinwon Life Sciences Receives MFDS Approval for Phase 1 Clinical Trial Plan of Hepatitis C Prevention Vaccine

[Asia Economy Reporter Jang Hyowon] On the 21st, GeneOne Life Science announced that it received approval from the Ministry of Food and Drug Safety (MFDS) for a clinical trial plan for GLS-6100, a DNA vaccine that prevents hepatitis C targeting high-risk groups for hepatitis C.

This clinical study is a single-center, open-label, dose-escalation Phase 1 clinical trial to evaluate the safety, tolerability, and immune response of GLS-6100 administered intradermally to healthy adults, and will be conducted with a total of 32 participants.

A company official stated, "GLS-6100 is one of our company's hepatitis C DNA vaccine products under development to overcome the limitations of hepatitis C vaccine development, which was impossible due to frequent mutations of the HCV virus, by inducing cellular vaccine immune responses using immune T cells," adding, "We are pursuing clinical development domestically along with GLS-6150, a vaccine that prevents reinfection in patients cured of chronic hepatitis C."

In particular, he emphasized, "The Phase 1 clinical trial approval of GLS-6100 was an achievement attained upon completion of the Phase 1 clinical study of GLS-6150 and the conclusion of a national project selected by the Ministry of Health and Welfare in 2017 for immune vaccine development, which we have diligently carried out."

Meanwhile, it was explained that although the hepatitis C preventive vaccine market is a technically challenging field, the number of competing products and companies is not large, and the development stages are similar, making it possible to lead global development. If successful, it is an attractive field that can create a new vaccine market as well as secure a leading position in the market.

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