GC Green Cross announced on the 11th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for the domestic Phase 2 clinical trial plan (IND) of its COVID-19 mRNA (messenger ribonucleic acid) vaccine candidate “GC4006A.”

The Phase 2 trial will focus on evaluating the optimal clinical dose and immunogenicity of GC4006A through a direct comparison with an active control group in healthy adults and elderly subjects aged 19 to 85. The company plans to begin first patient dosing within this year to fully launch the clinical trial and to submit the Phase 3 clinical trial IND next year.

GC Green Cross aims to achieve self-sufficiency in domestically produced mRNA vaccines by 2028. It is proceeding without delay according to the schedule of a government national R&D project led by the Korea Disease Control and Prevention Agency, the National Institute of Health, and the Korea Health Industry Development Institute, among others. Based on technology accumulated since 2019, GC Green Cross has internalized the entire production process for mRNA pharmaceuticals, from cell line development and mRNA synthesis to LNP (Lipid Nanoparticle) formulation, finished product manufacturing, and sophisticated quality analysis.

The company plans to use its internally validated mRNA-LNP platform, proven through this clinical trial, not only for the commercialization of its COVID-19 vaccine but also to expand its pipeline into next-generation immuno-oncology drugs and treatments for rare genetic diseases. LNP refers to lipid nanoparticles. These microscopic droplets of oil protect genetic materials such as mRNA from degradation and safely deliver them into cells. They are regarded as the key technological element that completed the effectiveness of mRNA vaccines.

The mRNA platform technology is rapidly expanding its application scope beyond infectious disease prevention, driven recently by cancer vaccine achievements from Moderna. According to global market research firm Grand View Research, the global mRNA vaccine and therapeutics market is projected to reach approximately USD 31.3 billion (around KRW 42 trillion) by 2030.

Lee Jae-woo, Head of R&D at GC Green Cross, said, “The approval of this Phase 2 IND is an important milestone for clearly validating GC Green Cross’s mRNA-LNP platform through clinical trials and securing sovereignty in domestically produced vaccines,” adding, “Based on our validated platform technology, we are considering expanding our pipeline into various disease areas, including vaccine self-sufficiency.”

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