GC Green Cross Submits IND for Phase 2 Clinical Trial of COVID-19 mRNA Vaccine...Selected for Disease Control Agency Support Project

GC Green Cross announced on July 27 that it had submitted a change in the phase 2 clinical trial plan (IND) for its COVID-19 mRNA vaccine candidate 'GC4006A' to the Ministry of Food and Drug Safety on July 24.

GC Green Cross Headquarters. GC Green Cross

GC Green Cross also stated that it was selected as the company to conduct the phase 2 clinical study for the 'Pandemic Preparedness mRNA Vaccine Development Support Project,' supervised by the Korea Disease Control and Prevention Agency and the Korea Health Industry Development Institute.

This project, led by the government, aims to achieve self-sufficiency in COVID-19 vaccines, which have thus far relied entirely on imports, and to secure domestic development capabilities for mRNA vaccines that will allow rapid response to future pandemics. With this selection, GC Green Cross will receive funding for clinical research and development, and the company plans to obtain final product approval for the COVID-19 mRNA vaccine by 2028 in accordance with the government roadmap.

According to the plan submitted to the Ministry of Food and Drug Safety, this phase 2 clinical trial will evaluate the optimal clinical dose and immunogenicity of GC4006A compared to an active control group, targeting healthy adults and the elderly aged 19 to 85. Notably, GC4006A is the first pipeline from GC Green Cross to enter the clinical stage utilizing the company's independently developed mRNA-LNP platform. The company regards this phase as a crucial step in demonstrating the competitiveness and scalability of its platform technology.

Previously, at the end of last year, GC Green Cross was selected to participate in the phase 1 clinical study under the same project and is currently conducting the phase 1 trial. Results confirming safety and tolerability in healthy adults aged 19 to 64 were submitted to the Ministry of Food and Drug Safety after one month. Based on these results, the company plans to fully commence phase 2 clinical trials within this year and complete the phase 3 IND application in the second half of next year.

Jae-woo Lee, Head of Development 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," adding, "Through this project, we will contribute to domestic vaccine self-sufficiency and establish globally competitive proprietary technology."

This content was produced with the assistance of AI translation services.