GC Biopharma (006280) is accelerating development toward domestic self-sufficiency in mRNA vaccines by 2028, entering a Phase 2 clinical trial in South Korea for its COVID-19 mRNA vaccine candidate. The company plans to validate its proprietary mRNA-LNP platform through the trial and then expand its use beyond infectious disease vaccines into immuno-oncology drugs and treatments for rare genetic disorders.
GC Biopharma said on the 11th that the Ministry of Food and Drug Safety had approved the investigational new drug (IND) application for a domestic Phase 2 trial of GC4006A, its COVID-19 mRNA vaccine candidate.
The Phase 2 trial will assess the optimal clinical dose and immunogenicity of GC4006A in healthy adults and older adults aged 19 to 85, using a direct comparison with an active control group. The company plans to begin the trial in earnest with the first patient dosing this year and to submit a Phase 3 IND application in 2027.
GC Biopharma said it is keeping to schedule on a government-funded national 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 mRNA vaccine self-sufficiency by 2028. Drawing on expertise built up since 2019, the company has brought in-house the entire mRNA drug production process, from cell line development to mRNA synthesis, LNP formulation, finished-product manufacturing and precision quality analysis.
Based on the proprietary mRNA-LNP platform to be validated through the trial, the company plans to expand its pipeline beyond commercializing a COVID-19 vaccine into next-generation immuno-oncology drugs and treatments for rare genetic disorders.
Recent results from Moderna's mRNA cancer vaccine and similar advances have rapidly widened the range of applications for mRNA platform technology, which had been concentrated on preventing infectious diseases. The global market for mRNA vaccines and therapeutics is expected to grow sharply to about $31.3 billion by 2030, according to Grand View Research.
"This Phase 2 IND approval is an important milestone in firmly validating our mRNA-LNP platform through clinical trials and securing sovereignty over domestically produced vaccines," said Lee Jae-woo, head of GC Biopharma's development division. "Based on the validated platform technology, we are reviewing an expansion of our pipeline into a range of disease areas, as well as vaccine self-sufficiency."
