Jinwon Life Sciences Submits Application for Phase 1/2 Clinical Trial Approval of COVID-19 Vaccine to MFDS

[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 2nd that it has submitted an application for clinical trial approval to the Ministry of Food and Drug Safety (MFDS) to simultaneously conduct Phase 1 and Phase 2 clinical trials for the DNA vaccine GLS-5310, which prevents COVID-19.

The company explained that the clinical study is a Phase 1/2 clinical trial to evaluate the safety, tolerability, and immunogenicity of the DNA vaccine GLS-5310 against the COVID-19 virus (SARS-CoV-2), and it will be conducted at Korea University Guro Hospital and four other clinical institutions.

A company representative stated, “GLS-5310 was selected for a research project by the Korea Disease Control and Prevention Agency in April, conducting preclinical studies from candidate substance derivation, and through prior consultation with the MFDS, we submitted the clinical trial approval application. Unlike other COVID-19 vaccines, GLS-5310 includes an additional antigen besides the Spike antigen to enhance preventive efficacy. We also prepared for large-scale administration of GLS-5310 by using a new injection device that is convenient, inexpensive, and painless, developed jointly with overseas university research teams.”

Park Younggeun, CEO of GeneOne Life Science, said, “The development of the COVID-19 vaccine GLS-5310 is yielding results through the dedication and cooperation of domestic and international government agencies and collaborative research institutions. In particular, by developing an innovative new DNA vaccine injection device, we have secured core foundational technologies necessary for nucleic acid vaccine product development, from vaccine design to current Good Manufacturing Practice (cGMP) capabilities and convenient, efficacy-enhancing injection technology.”

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