GC Biopharma has submitted a domestic IND application for its COVID-19 mRNA vaccine candidate, GC4006A, to the Korean Ministry of Food and Drug Safety, aiming to evaluate its safety and immunogenicity in healthy adults.

The company announced on September 22nd that it is progressing with its clinical trial plans for GC4006A, which was developed on an in-house mRNA-LNP platform since 2019.

GC Biopharma's development of GC4006A was accelerated after being selected for the Korea CDC's Pandemic Preparedness mRNA Vaccine Development Support Project, which aims to localize mRNA vaccine production by 2028.

This project has helped the company advance its research and development efforts, with plans to support local vaccine manufacturing and research through 2028.

The company also aims to expand its mRNA platform to other therapeutic areas, including rare genetic diseases, cancer immunotherapy, and inflammatory conditions, leveraging its end-to-end development capabilities.

GC Biopharma's proprietary mRNA-LNP platform allows it to handle the entire development process independently, with plans to obtain IND approval within 2025 and begin clinical trials early next year.

The platform's versatility could enable rapid responses to future pandemics within 100 days, highlighting its potential for next-generation pandemic preparedness.

In non-clinical trials, GC4006A has demonstrated the ability to induce both humoral and cellular immune responses, comparable to existing commercial vaccines, indicating promising efficacy.

GC Biopharma's R&D efforts are supported by government initiatives, including the 'Pandemic Preparedness mRNA Vaccine Development Support Project,' which aims to make Korea self-sufficient in mRNA vaccine production by 2028.

The vaccine is based on GC Biopharma's proprietary mRNA-LNP platform, which has been under development since 2019, enabling the company to manage the entire mRNA drug development process.

The company's goal is to complete safety and immunogenicity evaluations in phase 1 trials, with plans for approval and initial vaccine administration early next year.

Overall, GC Biopharma's efforts reflect a strategic push to establish a self-reliant, versatile mRNA vaccine platform capable of addressing current and future infectious diseases.