GC Green Cross announced on the 22nd that it has submitted a domestic Phase 1 clinical trial plan (IND) for the COVID-19 mRNA (messenger ribonucleic acid) vaccine candidate 'GC4006A' to the Ministry of Food and Drug Safety (MFDS).

The development of the COVID-19 vaccine candidate GC4006A was initiated after GC Green Cross was selected in April as a target company for the mRNA vaccine development support project for pandemic preparedness, organized by the Korea Disease Control and Prevention Agency (KDCA). This project, led by the KDCA, aims to localize mRNA vaccines by 2028.

GC Green Cross plans to evaluate the safety and immunogenicity of healthy adults in this Phase 1 clinical trial. The company anticipates IND approval for Phase 1 within the year and plans to administer the first dose to patients early next year. In preclinical trials, it demonstrated an antibody generation profile similar to existing commercial vaccines and showed effective cellular immune responses attacking virus-infected cells.

Notably, GC4006A is considered a major achievement of the mRNA-LNP (Lipid Nanoparticle) platform, a core delivery technology for mRNA vaccines, developed by GC Green Cross. Through mRNA-LNP research, the company has also secured the capability to independently conduct the entire process of mRNA pharmaceutical development. A GC Green Cross representative stated, “We expect to verify the technological prowess of the mRNA-LNP vaccine platform through this clinical trial,” adding, “If the platform technology is validated, it is expected to enable responses within 100 days in the event of a new pandemic.”

GC Green Cross plans to expand the mRNA-LNP platform technology to various pipelines, including treatments for rare genetic disorders, chronic inflammatory diseases, cancer immunotherapy, and vaccines. The company is also exploring global co-development and technology transfer using this platform.

Jae-Wook Jung, Head of R&D at GC Green Cross, stated, “GC Green Cross is the only domestic pharmaceutical company that has internalized the end-to-end process for developing mRNA pharmaceuticals,” adding, “Starting with the COVID-19 mRNA vaccine, we will expand and apply this platform technology to various disease areas.”

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