GC Biopharma提交GC4006A新冠mRNA疫苗二期临床变更IND申请

GC Biopharma is pursuing entry into a Phase 2 clinical trial for its COVID-19 messenger ribonucleic acid (mRNA) vaccine. The company aims to obtain product approval by 2028 to achieve domestic production of COVID-19 vaccines, which have relied on imports.
GC Biopharma said on the 27th that it had filed an application on the 24th with the Ministry of Food and Drug Safety for an amended investigational new drug (IND) approval for a Phase 2 clinical trial of its COVID-19 mRNA vaccine candidate "GC4006A." The company had earlier been selected as a company to conduct the Phase 2 clinical research project under the "mRNA Vaccine Development Support Program for Pandemic Preparedness," overseen by the Korea Disease Control and Prevention Agency and the Korea Health Industry Development Institute.
The trial will evaluate the optimal dosage and immunogenicity of GC4006A by directly comparing it with an active control group, targeting healthy adults and elderly people aged 19 to 85. GC4006A is the first candidate to enter the clinical stage using the mRNA-lipid nanoparticle (LNP) platform independently developed by GC Biopharma.
GC Biopharma was also selected as a company for Phase 1 clinical support under the same program late last year and is currently evaluating safety and tolerability in healthy adults aged 19 to 64. The company submitted the one-month post-dose results of the Phase 1 trial to the Ministry of Food and Drug Safety, and based on these plans to begin the Phase 2 trial this year. It plans to file a Phase 3 clinical trial plan in the second half of next year, with the goal of obtaining product approval by 2028.
Through this program, the government intends to establish a foundation for COVID-19 vaccine self-sufficiency and secure domestic mRNA technology capabilities that can rapidly develop and supply vaccines when new infectious diseases emerge.
"The mRNA platform is a core technology that enables the rapid development and supply of vaccines in the event of a future pandemic," said Lee Jae-woo, head of GC Biopharma's development division. "We will contribute to domestic vaccine self-sufficiency and complete independent technology at a global level."