[Edaily Reporter KIM SAE-MI ] GC Biopharma Corp. will begin Phase 2 clinical trials of its COVID-19 vaccine, which utilizes the company’s proprietary messenger ribonucleic acid (mRNA)-lipid nanoparticle (LNP) platform, before the end of the year.

GC Biopharma Corp. announced on the 11th that it had received approval from the Ministry of Food and Drug Safety for the domestic Phase 2 clinical trial plan (IND) for its COVID-19 mRNA vaccine candidate, “GC4006A.”

This clinical trial will be conducted on healthy adults and seniors aged 19 to 85. The company plans to determine the optimal clinical dose of GC4006A and evaluate its immunogenicity through direct comparison with an active control group. The company plans to begin administering the vaccine to the first patients by the end of this year and submit an Investigational New Drug (IND) application for a Phase 3 clinical trial next year.

Green Cross Corporation(006280)The company is currently carrying out a government-funded project led by the Korea Disease Control and Prevention Agency, the National Institute of Health, and the Korea Health Industry Development Institute, with the goal of achieving self-sufficiency in domestically produced mRNA vaccines by 2028.

Since 2019, the company has been developing mRNA-related technologies and has established an integrated infrastructure capable of handling the entire process in-house—from cell line development to mRNA synthesis, LNP formulation, finished product manufacturing, and quality analysis. Through this Phase 2 clinical trial, the company intends to validate the clinical performance and commercialization potential of its proprietary mRNA-LNP platform.

The company is also considering expanding the application scope of its mRNA-LNP platform beyond COVID-19 vaccines to include immuno-oncology drugs and treatments for rare genetic diseases.

Lee Jae-woo, Head of Development at GC Biopharma Corp., stated, “This Phase 2 clinical trial IND approval is a significant milestone toward validating our proprietary mRNA-LNP platform in clinical settings and securing domestic vaccine sovereignty.” He added, “Based on this validated platform technology, we are exploring not only vaccine self-sufficiency but also the expansion of our pipeline into various disease areas.”