Barythrax (recombinant protein anthrax vaccine) / GC Biopharma - LARVOL DELTA

Serological correlates of protection and long-term efficacy of a novel recombinant protective antigen-based anthrax vaccine in a rabbit model. (PubMed, Vaccine) - "These findings highlight the protective efficacy and durability of GC1109-induced immunity against lethal B. anthracis challenge. The study supports the continued development of GC1109 as a viable anthrax vaccine candidate and underscores its potential for emergency preparedness in Korea."

Journal • Preclinical • Infectious Disease

Korea approves first domestic anthrax vaccine from GC Biopharma (Chosun Biz) - "A domestically produced vaccine to combat the deadly biological weapon anthrax has been approved for the first time. The Ministry of Food and Drug Safety announced on the 8th that it has approved the genetically engineered anthrax vaccine 'Baritrax' (adherent anthrax vaccine) applied for by GC Biopharma...'Baritrax' works on the principle that the human body experiences anthrax proteins in a weakened form and induces antibodies against them. GC Biopharma produced the vaccine using a recombinant method by inserting genes that create two anthrax toxin proteins into microbial DNA and cultivating and purifying them."

Korea approval • Infectious Disease

GC Biopharma Receives MFDS Approval for World's First Recombinant Anthrax Vaccine (PRNewswire) - "GC Biopharma announced 09. Apr. 2025 that the Korean Ministry of Food and Drug Safety (MFDS) has approved its anthrax vaccine, BARYTHRAX, jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA)....With the approval by MFDS, BARYTHRAX has become Korea's 39th novel drug."

Korea approval • Infectious Disease

Immunogenicity and Protective Efficacy of Recombinant Protective Antigen Anthrax Vaccine (GC1109) in A/J Mice Model. (PubMed, Vaccine) - "The threshold 50 % neutralization factor (NF) of TNA showing 70 % probability of protection was 0.21 in A/J mice with 1,200 LD Sterne spores challenge. These results indicate that GC1109 is a promising candidate as a new-generation anthrax vaccine and that a booster dose might provide enhanced protection by producing toxin-neutralizing antibodies."

Journal • Preclinical

A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 (clinicaltrials.gov) - P2 | N=240 | Completed | Sponsor: Green Cross Corporation | Not yet recruiting ➔ Completed | N=345 ➔ 240

Enrollment change • Trial completion

A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 (clinicaltrials.gov) - P2; N=345; Not yet recruiting; Sponsor: Green Cross Corporation; Trial completion date: Nov 2016 ➔ Jan 2023; Trial primary completion date: Oct 2012 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date

Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study. (PubMed, Vaccine) - "A new rPA anthrax vaccine GC1109 was immunogenic after three doses of intramuscular administration, and was well-tolerated."

Clinical • Journal • P2 data

Evaluation of the protective efficacy of recombinant protective antigen vaccine (GC1109)-immunized human sera using passive immunization in a mouse model. (PubMed, Vaccine) - "The estimated TNA titer for 50% survival rate against lethal challenge was 197 (95% confidence interval of 149 and 260). The result suggest that GC1109 is protective against exposure to B. anthracis and the TNA titer of vaccinated serum can be an indicator for protective efficacy."

Journal • Preclinical