GC Biopharma to Advance COVID-19 mRNA Vaccine to Phase 2 Clinical Trials with Government Support

GC Biopharma announced on July 27 that it has been chosen as the lead company for Phase 2 clinical trials of an mRNA COVID-19 vaccine, as part of a government-funded initiative to prepare for future pandemics. The company is set to receive research and development funding for its work.

The company submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety on July 24 for its mRNA vaccine candidate, named 'GC4006A'. This initiative, organized by the Korea Disease Control and Prevention Agency and the Korea Health Industry Development Institute, aims to establish domestic development capabilities for COVID-19 vaccines, which are currently heavily reliant on imports, and to secure mRNA vaccine technology for future infectious disease outbreaks.

GC Biopharma plans to achieve marketing approval for its COVID-19 mRNA vaccine by 2028, aligning with the government's development timeline. The Phase 2 trials will assess the appropriate dosage and immunogenicity of GC4006A in healthy adults and the elderly, aged 19 to 85. The study will directly compare the vaccine's performance against an active control group receiving existing vaccines.

GC4006A is the first candidate to utilize GC Biopharma's proprietary mRNA lipid nanoparticle (LNP) platform, which the company also intends to evaluate during these trials. Last year, the company was selected for Phase 1 clinical trial support under the same program and is currently conducting those trials. Initial results on safety and tolerability in healthy adults aged 19-64 were submitted to the Ministry of Food and Drug Safety. Based on this, GC Biopharma plans to commence Phase 2 trials within the year and submit an IND for Phase 3 by the second half of next year.

"The mRNA platform is a technology for rapidly developing and supplying vaccines during infectious disease outbreaks," said Lee Jae-woo, head of GC Biopharma's development division. "Through this project, we will enhance domestic vaccine development capabilities."

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The mRNA platform is a technology for rapidly developing and supplying vaccines during infectious disease outbreaks. Through this project, we will enhance domestic vaccine development capabilities.