Green Cross selected for KDCA COVID-19 mRNA vaccine Phase 2 trial support program, files IND amendment

Green Cross has been selected as a participant in the Korea Disease Control and Prevention Agency's COVID-19 mRNA vaccine Phase 2 trial support program, accelerating efforts to achieve domestic self-sufficiency in vaccine supply.

Green Cross announced Monday that it has been chosen to carry out a Phase 2 research project under the "mRNA Vaccine Development Support Program for Pandemic Preparedness," jointly run by the KDCA and the Korea Health Industry Development Institute. The company said it has also submitted an amended investigational new drug application to the Ministry of Food and Drug Safety to begin a Phase 2 trial of its COVID-19 mRNA vaccine candidate, GC4006A.

The project is a national initiative aimed at localizing COVID-19 vaccine production — which has long depended on imports — and enabling a rapid response to future pandemic threats. Through its selection, Green Cross will receive government funding for clinical research and development, with a goal of securing final regulatory approval for its COVID-19 mRNA vaccine by 2028.

The Phase 2 trial will enroll healthy adults and older participants between the ages of 19 and 85, directly comparing GC4006A against an active control vaccine to evaluate the candidate's optimal clinical dose and immunogenicity. GC4006A is the first clinical pipeline product built on Green Cross's proprietary mRNA-LNP (lipid nanoparticle) platform technology. The trial is expected to serve as a proving ground for both the commercial viability and scalability of the company's homegrown core technology.

Green Cross was selected late last year as a Phase 1 trial participant under the same program and subsequently submitted one-month safety and tolerability data from adults aged 19 to 64 to the Ministry of Food and Drug Safety. Building on those results, the company plans to formally begin the Phase 2 trial before the end of this year and to file a Phase 3 trial IND in the second half of next year.

"The mRNA platform is a core technology that will enable rapid vaccine supply when a future pandemic strikes," said Lee Jae-woo, head of Green Cross's development division. "Through this project, we aim to contribute to vaccine self-sufficiency and secure world-class proprietary technology."