World's First Recombinant Anthrax Vaccine: GC Biopharma Applies for Approval

GC Biopharma has applied for approval of GC1109, potentially the world's first recombinant anthrax vaccine, in South Korea. Developed with KDCA, it has shown promising safety and efficacy in Phase II trials. This vaccine is a critical step in enhancing biodefense and securing national health security.

In a significant stride towards combating bioterrorism threats and infectious diseases, South Korean pharmaceutical company GC Biopharma has taken a decisive step by seeking local regulatory approval for the world's first recombinant anthrax vaccine, named GC1109. This innovative vaccine, a product of collaborative efforts between GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA), was submitted for marketing approval to the Korean Ministry of Food and Drug Safety (MFDS) on November 1, 2023.

Anthrax, a life-threatening disease caused by the bacterium Bacillus anthracis, is classified as a Class 1 infectious disease, with untreated cases boasting a fatality rate as high as 97%. The urgency for an effective vaccine is underscored by the risk of the disease being utilized as a bioweapon, prompting swift action in vaccine development.

The recombinant vaccine GC1109 harnesses protective antigen (PA) produced through advanced recombinant DNA technology, targeting the lethal factor (LF) and edema factor (EF) proteins that form the core of the anthrax toxin. This approach has the potential to revolutionize anthrax prevention.

GC Biopharma has been at the forefront of this vaccine's research and development since 2002, backed by the KDCA. The recent Phase II clinical trials have been promising, demonstrating the vaccine's immunogenicity and safety. 

Healthy volunteers who received the vaccine intramuscularly developed antibodies capable of neutralizing anthrax toxins. Notably, the adverse reactions observed were comparable to those seen in the placebo group, marking a significant milestone in the vaccine's development trajectory.

Conducting human efficacy studies for anthrax vaccines poses ethical and practical challenges due to the dangers involved and the low incidence of the disease. Consequently, GC Biopharma relied on the "Animal Rule" for establishing clinical benefits, where animal study data can substitute human trials. Their animal efficacy study revealed that the vaccine induced a robust and durable antibody response, ensuring high survival rates following exposure to anthrax spores.

As the world awaits the MFDS's decision, the potential approval of GC1109 could mark a landmark achievement in preventive medicine, offering a new layer of defense against a formidable and historically significant pathogen.

About Author: Hüseyin Kandemir

As a medical journalist with over 20 years of experience, I have served as an Editor and Reporter for various magazines, newspapers, and online broadcasting platforms, consistently demonstrating a strong commitment to excellence in journalism. My specialization includes medical science, digital health, AI for health, data science, and biotechnology.