GC Pharma said Sept. 11 that its investigational COVID-19 mRNA vaccine, GC4006A, has received approval from South Korea’s Ministry of Food and Drug Safety to proceed with a Phase 2 clinical trial.
The Phase 2 trial will evaluate the optimal clinical dose and immunogenicity of GC4006A in healthy adults and older adults ages 19 to 85 through a head-to-head comparison with an active comparator. The company plans to begin dosing the first patient this year, formally launching the Phase 2 trial, and submit an investigational new drug application for a Phase 3 trial in 2027.
GC Pharma is the only South Korean company proceeding without delays under a government-funded project led by the Korea Disease Control and Prevention Agency, the National Institute of Health and the Korea Health Industry Development Institute, with the goal of achieving domestic self-sufficiency in mRNA vaccines by 2028.
mRNA is genetic material that delivers instructions to cells to produce specific proteins. Because it is easily broken down in the body, it is encapsulated in lipid nanoparticles (LNPs) for safe delivery to cells. Its applications are expanding beyond COVID-19 vaccines to cancer vaccines and treatments for genetic and rare diseases.
Based on its accumulated technology since 2019, GC Pharma has brought in-house the entire mRNA drug manufacturing process, from cell line development and mRNA synthesis to LNP formulation, finished-product manufacturing and advanced quality analysis.
The company said it plans to use its validated mRNA-LNP platform to expand its pipeline beyond commercializing a COVID-19 vaccine into next-generation immuno-oncology drugs and treatments for rare genetic diseases.
The application of mRNA platform technology, which had focused primarily on infectious disease prevention, is rapidly expanding following recent advances including Moderna’s progress with mRNA cancer vaccines. According to Grand View Research, a global market research firm, the global mRNA vaccine and therapeutics market is projected to grow rapidly to about $31.3 billion by 2030.
Lee Jae-woo, head of development at GC Pharma, said, “The approval of the Phase 2 IND is an important milestone in firmly validating our mRNA-LNP platform through clinical trials and securing vaccine sovereignty through domestic production. Based on our validated platform technology, we are considering expanding our pipeline into various disease areas as well as achieving self-sufficiency in vaccines.”