GC Biopharma was selected by the Korea Disease Control and Prevention Agency as a corporation to receive support for a phase 1 clinical study under the "pandemic preparedness mRNA Vaccine development support project."
GC Biopharma said on the 15th that "it was ultimately included among the phase 1 clinical support targets, limited to only two of the four corporations selected at the nonclinical stage." The project is a government-led initiative to secure domestic mRNA Vaccine development capability in preparation for the next pandemic.
GC Biopharma is regarded as the only corporation in Korea capable of independently carrying out the entire process from discovering candidates to manufacturing and production based on its in-house mRNA-LNP (lipid nanoparticle) platform. In particular, it is cited as having strengths in possessing key enabling technologies across the board, including codon (the base sequence in mRNA that instructs protein production) optimization using artificial intelligence (AI), patents related to UTR (untranslated regions) that enhance the stability of gene expression, and LNP technology that improves delivery efficiency.
The company aims to obtain approval for an investigational new drug (IND) application within the year for a phase 1 clinical trial of its COVID-19 mRNA Vaccine candidate. After initiating phase 1, it plans to proceed quickly with the research and submit a phase 2 IND in the second half of 2026.
Jeong Jae-uk, head of research and development (R&D) at GC Biopharma, said, "Securing a homegrown mRNA Vaccine platform is a key task to strengthen the nation's disease control capabilities," adding, "with this government support as a springboard, we will further accelerate development and make a tangible contribution to the national disease control system."