Pharma Focus Asia

GC Biopharma Requests MFDS Approval for Pioneering Recombinant Anthrax Vaccine

Monday, November 06, 2023

GC Biopharma officially submitted an application for marketing approval to the Korean Ministry of Food and Drug Safety (MFDS) for their groundbreaking anthrax vaccine, "GC1109." This vaccine, developed in collaboration with the Korea Disease Control and Prevention Agency (KDCA), represents a significant milestone as the world's first recombinant anthrax vaccine.

"GC1109" is formulated with protective antigen (PA) as its active pharmaceutical ingredient, which is produced through advanced recombinant DNA technology. This technology allows for the delivery of two essential proteins from the anthrax toxin, lethal factor (LF) and edema factor (EF), into cells.

Anthrax, a severe and potentially fatal infectious disease caused by Bacillus anthracis, is classified as a Class 1 infectious disease under the Infectious Disease Control and Prevention Act, with a lethality rate as high as 97% if left untreated. In response to the ongoing threat of bioterrorism and the potential national crisis it poses, GC Biopharma, in partnership with KDCA, initiated research efforts in 2002 to develop a recombinant anthrax vaccine.

The Phase II clinical trial for "GC1109" demonstrated both its immunogenicity and safety among healthy volunteers. Those who received the vaccine via intramuscular injection generated sufficient antibodies to neutralize anthrax toxins, with adverse reactions and events comparable to those in the placebo group.

Conducting human clinical efficacy studies for an anthrax vaccine presents ethical and practical challenges, as it is unsafe to expose volunteers to lethal Bacillus anthracis, and field trials are unfeasible due to the low incidence of anthrax cases. In such cases, the "Animal Rule" specified in The Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis can be employed. This rule allows the utilization of animal efficacy data to establish the clinical benefit of the vaccine if substantial evidence from animal studies supports its effectiveness. Notably, in animal efficacy studies, "GC1109" induced neutralizing antibodies that remained at high levels even six months after the fourth vaccine dose, demonstrating a high survival rate against Bacillus anthracis spore challenges.

GC Biopharma underscores the significance of this achievement in localizing the anthrax vaccine, emphasizing the importance of ensuring vaccine sovereignty, public health, and national security. The company pledges to continue their commitment to localizing critical medicines and ensuring a stable supply of essential medical products, consistent with their track record of providing other vaccines and blood products since their inception.



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