World's First Recombinant Anthrax Vaccine Candidate Seeks Approval

GC Biopharma announced today that it has applied to the Korean Ministry of Food and Drug Safety for the marketing approval of "GC1109", an anthrax vaccine jointly developed by the company and the Korea Disease Control and Prevention Agency (KDCA).

If approved, "GC1109" will be the world's first recombinant anthrax vaccine.

'GC1109' contains a protective antigen as its active pharmaceutical ingredient, produced by recombinant DNA technology. This delivers two types of proteins, comprising anthrax toxin, lethal factor, and edema factor, into cells.

In the Phase II clinical trial, the vaccine's immunogenicity and safety were demonstrated with healthy volunteers. Subjects who received intramuscular administration of GC1109 generated antibodies sufficient to neutralize anthrax toxins, while adverse drug reactions or solicited adverse events were similar to those of the placebo group.

In the animal efficacy study, GC1109 induced neutralizing antibody, which remained at a high level even six months after the 4th dose of the vaccine, with a high survival rate against the bacillus anthracis spore challenge.

GC Biopharma stated in a press release on November 5, 2023, "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."

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 the evidence from the animal studies provides substantial grounds for the product's effectiveness.

Anthrax, caused by Bacillus anthracis, is a Class 1 infectious disease by the Infectious Disease Control and Prevention Act, with a lethality rate of up to 97% if untreated.

To prepare against potential bioterrorism and consequent national crisis, GC Biopharma, under the research project supported by KDCA, has been developing a recombinant vaccine for anthrax since 2002.

GC Biopharma (formerly Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines.

According to the U.S. CDC, people get infected with anthrax when spores get into the body. When this happens, the spores can be activated and become anthrax bacteria.

Then, the bacteria can multiply, spread out in the body, produce toxins (poisons), and cause severe illness.

The good news is anthrax is not contagious. 

You cannot catch anthrax from another person the way you might catch a cold or the flu.

In rare cases, person-to-person transmission has been reported with cutaneous anthrax, where discharges from skin lesions might be infectious, says the CDC.