GC Green Cross has been selected for the government's messenger ribonucleic acid (mRNA) vaccine development support project. The company submitted an Investigational New Drug (IND) application for a Phase 2 clinical trial to the Ministry of Food and Drug Safety, aiming to accelerate the development of a domestic mRNA vaccine.
On July 27, GC Green Cross announced that it has been chosen as the company to conduct the Phase 2 clinical research project under the 'Pandemic Preparedness mRNA Vaccine Development Support Project' led by the Korea Disease Control and Prevention Agency and the Korea Health Industry Development Institute.
Additionally, on July 24, the company submitted the IND for its COVID-19 mRNA vaccine candidate, 'GC4006A,' for the Phase 2 trial.
This initiative is part of a government project aimed at achieving self-sufficiency in COVID-19 vaccines, which have been entirely imported, and securing the capability to develop domestic mRNA vaccines to respond to future pandemics. As part of this project, GC Green Cross will receive funding for clinical research and plans to obtain approval for the COVID-19 mRNA vaccine by 2028.
According to the submitted plan, the Phase 2 trial will evaluate the optimal clinical dosage and immunogenicity of GC4006A in healthy adults aged 19 to 85, comparing it directly with an active control group.
The lipid nanoparticle (LNP) technology, which safely delivers mRNA to cells, is also considered a key component.
GC4006A is the first pipeline to enter the clinical stage using the mRNA-LNP platform developed by GC Green Cross. The company expects to validate the competitiveness and scalability of its platform technology through this clinical trial.
GC Green Cross was selected as a supporting company for the Phase 1 clinical study of the same project at the end of last year and is currently conducting the Phase 1 trial. The company has submitted one-month results on safety and tolerability for healthy adults aged 19 to 64 to the Ministry of Food and Drug Safety and plans to initiate the Phase 2 trial within the year, with an IND application for Phase 3 expected in the second half of next year.
Lee Jae-woo, head of the development division at GC Green Cross, stated, "mRNA platform technology is a key technology that enables rapid vaccine development and supply in the event of future pandemics. Through this project, we aim to contribute to domestic vaccine self-sufficiency and secure globally competitive independent technology."
* This article has been translated by AI.
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