GC Green Cross Receives Phase 2 IND Approval for COVID-19 mRNA Vaccine
"Goal of Achieving Vaccine Self-Sufficiency by 2028"
GC Green Cross announced on September 11 that it has received approval from the Ministry of Food and Drug Safety for the domestic Phase 2 clinical trial plan (IND) of its COVID-19 mRNA vaccine candidate, "GC4006A".
In this Phase 2 trial, the optimal clinical dose and immunogenicity of GC4006A will be evaluated through a direct comparison with the active control group, targeting healthy adults and elderly subjects aged 19 to 85 years. GC Green Cross plans to formally begin Phase 2 by administering the first dose to a patient within the year, and subsequently submit the Phase 3 IND application next year.
GC Green Cross is proceeding without delay on a government-funded project overseen by the Korea Disease Control and Prevention Agency, the National Institute of Health, and the Korea Health Industry Development Institute, aiming for self-sufficiency of domestic mRNA vaccines by 2028. Leveraging technological expertise accumulated since 2019, the company has internalized the entire production process for mRNA pharmaceuticals, including cell line development, mRNA synthesis, lipid nanoparticle (LNP) formulation, finished product manufacturing, and precision quality analysis.
Through this clinical trial, GC Green Cross intends to expand its pipeline beyond COVID-19 vaccine commercialization, based on its validated proprietary mRNA-LNP platform, to include next-generation immuno-oncology therapies and treatments for rare genetic diseases.
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Jae-Woo Lee, Head of the Development Division at GC Green Cross, said, "This approval of the Phase 2 IND is an important milestone toward securing domestic vaccine sovereignty by rigorously validating our mRNA-LNP platform through clinical trials." He added, "Based on this proven platform technology, we are not only pursuing vaccine self-sufficiency, but also considering pipeline expansion into a wide range of disease areas."
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