GCBiopharma will enter phase 2 of a coronavirus messenger ribonucleic acid (mRNA) vaccine candidate it is developing in-house. It plans to begin dosing the first patient within the year and apply for phase 3 investigational new drug (IND) approval in 2027.
GC Biopharma said on the 11th that the Ministery of Food and Drug Safety has approved the domestic phase 2 IND for the coronavirus mRNA Vaccine candidate "GC4006A."
This phase 2 trial will enroll healthy adults and older adults ages 19 to 85. Using an existing vaccine as a comparator, the main goal is to determine the appropriate dose of GC4006A and assess its immunogenicity.
GC Biopharma plans to dose the first patient within the year and ramp up phase 2. In 2027, it will submit the phase 3 IND and continue development with the goal of achieving domestic mRNA Vaccine self-sufficiency in 2028.
GC Biopharma's mRNA medicine manufacturing technology will be used in developing GC4006A. The company said it has secured end-to-end capabilities across the production process, from cell line development and mRNA synthesis to lipid nanoparticle (LNP) formulation, finished product manufacturing, and quality analytics. It has been developing the related technologies since 2019.
GC Biopharma is also reviewing ways to extend the mRNA-LNP technology gained through coronavirus vaccine development to other diseases. Targets include next-generation immuno-oncology therapies and treatments for rare genetic disorders.