GC Green Cross Submits IND for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea

Aiming for IND Approval This Year and First Dosing Early Next Year

GC Green Cross announced on September 22 that it has submitted a Phase 1 clinical trial protocol (IND) for 'GC4006A,' its COVID-19 mRNA vaccine candidate, to the Ministry of Food and Drug Safety.

GC Green Cross Headquarters. GC Green Cross

GC4006A's development accelerated after GC Green Cross was selected in April for the "Pandemic Preparedness mRNA Vaccine Development Support Project" led by the Korea Disease Control and Prevention Agency (KDCA). The company explained that it is focusing its capabilities on this development, as the KDCA aims to localize mRNA vaccine production by 2028.

In this Phase 1 clinical trial, GC Green Cross plans to evaluate the safety and immunogenicity of GC4006A in healthy adults. The company expects to receive IND approval for the Phase 1 trial within this year and aims to begin the first dosing early next year.

In previous preclinical studies, GC4006A was found to induce not only a humoral immune response that generates antibody levels comparable to existing commercial vaccines, but also an effective cellular immune response that targets virus-infected cells.

GC4006A is a result of GC Green Cross's 'mRNA-LNP (Lipid Nanoparticle·gene delivery nanoparticle)' platform. Through mRNA-LNP research initiated in 2019, GC Green Cross has developed the capability to independently carry out all processes required for mRNA pharmaceutical development. The company anticipates that if its proprietary platform is validated through this clinical trial, it will be able to respond within 100 days in the event of a new pandemic.

Jung Jaeuk, Head of R&D at GC Green Cross, stated, "We are the first domestic pharmaceutical company to internalize an end-to-end process for mRNA drug development," adding, "Starting with the COVID-19 mRNA vaccine, we plan to expand this platform to various disease areas."

Meanwhile, GC Green Cross plans to expand its mRNA-LNP platform to a diverse pipeline, including rare genetic diseases, chronic inflammatory diseases, cancer immunotherapies, and vaccines. The company is also exploring the possibility of joint development and technology transfer with global pharmaceutical companies utilizing this platform.