GC Green Cross announced on the 27th that it has been selected as the company to carry out a phase 2 clinical trial project under the “mRNA Vaccine Development Support Project for Pandemic Preparedness,” overseen by the Korea Disease Control and Prevention Agency and the Korea Health Industry Development Institute.

On the 24th, GC Green Cross submitted an application for approval of a phase 2 clinical trial protocol amendment (IND) for its COVID-19 mRNA vaccine candidate “GC4006A” to the Ministry of Food and Drug Safety.

The project has been promoted to establish a domestic development base for COVID-19 vaccines, which currently have a high dependence on imports, and to secure mRNA vaccine technology that can be used to respond to future infectious disease outbreaks. With its selection for this project, GC Green Cross will receive support for clinical research and development expenses.

GC Green Cross stated that it has drawn up a plan to obtain marketing authorization for its COVID-19 mRNA vaccine by 2028 in line with the government’s development timeline.

According to the submitted clinical trial plan, the phase 2 study will evaluate the appropriate dosage and immunogenicity of GC4006A in healthy adults and elderly subjects aged 19 to 85 years. It will be conducted by directly comparing the candidate with an active control group receiving an existing vaccine.

GC4006A is the first candidate to enter the clinical stage using the company’s proprietary mRNA lipid nanoparticle (LNP) platform. The company also plans to assess the potential applicability of this platform through the current trial.

GC Green Cross was selected at the end of last year as a phase 1 clinical support company for the same project and is currently conducting the trial. It submitted to the Ministry of Food and Drug Safety the results confirming safety and tolerability over one month in healthy adults aged 19 to 64. Based on this, it plans to initiate phase 2 clinical trials within this year and submit a phase 3 IND in the second half of next year.

Lee Jae-woo, head of the Development Division at GC Green Cross, said, “The mRNA platform is a technology for rapidly developing and supplying vaccines when infectious diseases spread,” adding, “Through this project, we aim to strengthen domestic vaccine development capabilities.”

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