GC Biopharma announced 1 Nov. 2023 that it has applied for the marketing approval of “GC1109”, an anthrax vaccine jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA), to the Korean Ministry of Food and Drug Safety (MFDS).
‘GC1109’ contains protective antigen (PA) as its active pharmaceutical ingredients produced by recombinant DNA technology which delivers 2 types of proteins that comprise anthrax toxin, namely, lethal factor (LF) and edema factor (EF), into cells. If approved, “GC1109” will be the world’s first recombinant anthrax vaccine.
Anthrax, caused by Bacillus anthracis, is a Class 1 infectious disease by the Infectious Disease Control and Prevention Act with a lethality rate of as high as 97% if one is not treated early. In order to prepare against potential bioterrorism and consequent national crisis, GC Biopharma, under the research project supported by KDCA, has been working on developing a recombinant vaccine for anthrax since 2002.
In the Phase II clinical trial, the vaccine’s immunogenicity and safety has been demonstrated with healthy volunteers, where subjects who received intramuscular administration of GC1109 generated antibodies sufficient enough to neutralize anthrax toxins, while adverse drug reactions or solicited adverse events were similar to those of the placebo group.
Since it is unethical to expose human volunteers to lethal Bacillus anthracis, and field trials are not feasible due to a low incidence of anthrax, human clinical efficacy studies for an anthrax vaccine cannot be conducted. In such cases, under the “Animal Rule” of The Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis, animal efficacy data can be used to establish the vaccine’s clinical benefit if evidence from the animal studies provide substantial grounds for the effectiveness of the product. In the animal efficacy study, GC1109 induced neutralizing antibody which remained at a high level even after 6 months following the 4th dose of the vaccine, with high survival rate against the bacillus anthracis spore challenge.
GC Biopharma stated, “We believe in the significance of our journey to localize the anthrax vaccine in terms of securing vaccine sovereignty, while promoting public health and national security. GC Biopharma will continue to lead the localization of critical medicines and contribute to the stable supply of basic medical supplies as it has been doing for other vaccines and blood products since the foundation of the company.”