GC Biopharma(006280)'s domestically developed messenger ribonucleic acid (mRNA) COVID-19 vaccine, under development with government support, is entering phase 2 clinical trials.
The Korea Disease Control and Prevention Agency National Institute of Health said on the 24th that GC Biopharma, which is participating in the "pandemic readiness mRNA vaccine development support project," has submitted an investigational new drug (IND) application for a phase 2 clinical trial of its COVID-19 mRNA Vaccine candidate to the Ministery of Food and Drug Safety.
The application followed a prior review by the Ministery of Food and Drug Safety based on phase 1 results and nonclinical study data. It is a key step to initiate phase 2.
The domestic mRNA Vaccine development project is a national research and development (R&D) program that supports the entire process from nonclinical studies through phase 3. The government aims to secure a domestic mRNA platform to establish a system that can rapidly develop vaccines when new infectious diseases emerge.
Since April last year, the agency has been supporting nonclinical and clinical research centered on institutions with core mRNA technologies, and, in cooperation with related ministries including the Ministery of Food and Drug Safety, has been providing regulatory and technical support in parallel. Based on the results of a phase 1 study approved and conducted in December last year, GC Biopharma applied for this phase 2 trial.
The government has also completed the selection process for the phase 2 research project and plans to begin the study in August after signing agreements. If the Ministery of Food and Drug Safety approves the clinical trial plan, a clinical study will proceed to evaluate safety and immunogenicity by administering the vaccine candidate to healthy adults.
The government aims to secure a domestic mRNA Vaccine platform by 2028. By supporting everything from nonclinical studies to phase 3, sample production, and manufacturing process development, it plans to pursue marketing authorization and commercialization of the COVID-19 vaccine, and to build a foundation that allows new vaccines to be developed within 3 to 6 months by replacing only the antigen on the platform when new infectious diseases occur. In the event of a pandemic, the goal is to supply vaccines within a maximum of 200 days.
Nam Jae-hwan, director of the National Institute of Health, said, "The mRNA platform is a core technology applicable not only to COVID-19 vaccines but also to the development of treatments for various infectious diseases, cancer, and rare diseases," adding, "We will comprehensively support technology, regulation, and research infrastructure to ensure phase 2 proceeds successfully."
Im Seung-gwan, commissioner of the Korea Disease Control and Prevention Agency, said, "Domestic mRNA Vaccine development is meaningful for securing vaccine sovereignty and strengthening the nation's capacity to respond to infectious diseases," adding, "We will continue cooperation between project institutions and related ministries to support the research so it can proceed successfully."