GC Biopharma (GC Biopharma) is set to become the first participant in South Korea’s government-backed domestic COVID-19 mRNA vaccine program to advance into a Phase 2 clinical trial. The company plans to submit an investigational new drug (IND) application for the Phase 2 study to the Ministry of Food and Drug Safety (MFDS) this week. If approved, South Korea’s domestically developed mRNA vaccine program will enter its first late-stage clinical phase.
According to industry sources on July 23 (ET), GC Biopharma will submit its Phase 2 IND application for its COVID-19 mRNA vaccine candidate to the MFDS this week. Pending regulatory approval, the company aims to begin the Phase 2 trial as early as August.
Although GC Biopharma has not yet officially completed its Phase 1 study, the company has finished dosing all participants and secured interim analysis results, meeting the requirements to submit a Phase 2 IND application.
The filing marks the most advanced milestone to date under the government’s domestic mRNA vaccine development initiative. The Korea Disease Control and Prevention Agency (KDCA) launched the program with the goal of establishing a platform capable of producing and supplying a homegrown mRNA vaccine within 100 to 200 days of a future pandemic outbreak, using a phased competitive selection process.
During the preclinical stage, four companies were selected: GC Biopharma, Remonex, EuBiologics, and Korea BMI. Following subsequent evaluations, the field was narrowed to GC Biopharma and the Eyegene Consortium, led by Korea BMI, for clinical development support.
The KDCA originally designed the program to support up to two Phase 2 clinical projects. However, GC Biopharma was the only company to apply for Phase 2 support and will therefore carry out the project alone.
The Eyegene Consortium, led by Korea BMI, reportedly submitted its Phase 1 IND application last week. Because of differences in development timelines, the government is now pursuing a two-track strategy, with GC Biopharma advancing toward Phase 2 while the Korea BMI consortium remains in Phase 1.
A government official said, “The Phase 2 support program was originally designed to fund up to two projects, but only one application was submitted. Since the Korea BMI consortium is still conducting its Phase 1 trial due to its development timeline, the two projects will continue progressing at different clinical stages.”
