GC Biopharma is set to begin domestic clinical trials in earnest for its COVID-19 mRNA Vaccine candidate.
GC Biopharma said on the 19th that the phase 1 clinical trial protocol (IND) for its COVID-19 mRNA Vaccine candidate "GC4006A" has been approved by the Ministery of Food and Drug Safety.
Phase 1 is the stage that first confirms a vaccine's safety and in-body response in healthy adults. With this approval, GC Biopharma can start its first human clinical trial.
The IND approval came after GC Biopharma was selected as a corporations supported for phase 1 research under the Korea Disease Control and Prevention Agency's "support project for developing mRNA Vaccines in preparation for pandemics." After submitting the IND on the 9th, the approval process wrapped up relatively quickly, and the government's "localization of the mRNA Vaccine platform" policy is expected to gain momentum.
An mRNA Vaccine delivers the virus's genetic information to induce an immune response in the body, and is regarded as a technology that can respond relatively quickly even when new infectious diseases or variants emerge. While global pharmaceutical companies succeeded in commercialization during the COVID-19 pandemic, domestic independent development and production capacity is still not sufficiently in place.
GC Biopharma sees this phase 1 IND approval as a starting point for building a foundation for self-sufficiency in domestic mRNA Vaccines. After conducting phase 1, the company plans to submit a phase 2 IND in the second half of next year.
Lee Jae-woo, head of development at GC Biopharma, said, "Based on our mRNA platform capabilities, we will develop a safe and effective vaccine," and "through continuous research and development, we will contribute to strengthening vaccine sovereignty and building a public health safety net."