Study demonstrates strong immunogenicity and favorable safety profile for BARYTHRAX inj. (GC1109)
Robust Immune Response and Safety Confirmed
GC Biopharma, a South Korea–based global pharmaceutical company, announced that results from the Phase 2 clinical trial of its anthrax vaccine BARYTHRAX inj. (GC1109) have been published in the international journal Vaccine.
Developed jointly with the Korea Disease Control and Prevention Agency (KDCA), BARYTHRAX is the world’s first recombinant protein-based anthrax vaccine.
The randomized, double-blind, placebo-controlled study—approved by the Ministry of Food and Drug Safety (MFDS)—evaluated safety and immunogenicity in 240 healthy adults across five major Korean hospitals.
Results showed that BARYTHRAX elicited antibodies capable of neutralizing anthrax toxin above the predefined protective threshold, confirming strong immunogenicity and potential clinical protection against anthrax infection.
Safety assessments indicated that adverse events such as injection site pain, myalgia, fatigue, and malaise were mild and temporary, with no severe reactions or deaths reported, establishing a favorable safety profile.
A Step Forward in Vaccine Innovation
According to GC Biopharma, BARYTHRAX offers key advantages over traditional anthrax vaccines, which rely on live attenuated bacteria, by being safer and faster to manufacture at scale.
“This clinical research exemplifies successful academia–industry collaboration and marks a major milestone in the development of safe, effective vaccines,” said Dr. Nam Joong Kim, Principal Investigator and Professor at Seoul National University Hospital.
“We expect the success of Korea’s first recombinant anthrax vaccine to accelerate research in infectious diseases and enhance local vaccine production,” he added.
Dr. Chang Kyung Kang, lead author of the publication, highlighted that the study’s acceptance in Vaccine reflects its clinical relevance and global scientific value.
Jae-Uk Jeong, Head of R&D at GC Biopharma, noted that the positive Phase 2 outcomes position BARYTHRAX as a strategic asset for national biodefense and pandemic preparedness.
About BARYTHRAX inj. (GC1109)
- World’s first recombinant anthrax vaccine
- Korea’s 39th New Drug and 3rd New Drug Vaccine
- Developed using recombinant protein technology to express and purify the Protective Antigen (PA) protein from Bacillus anthracis—the key immunogenic component of the anthrax toxin
About Anthrax
Anthrax is a zoonotic infection caused by Bacillus anthracis, capable of affecting both humans and animals. It is classified as a potential bioterrorism threat, as aerosolized spores can cause severe respiratory infections with high mortality rates.
About GC Biopharma
GC Biopharma (formerly Green Cross Corporation) is a biopharmaceutical company headquartered in Yongin, South Korea, with over 50 years of experience in developing plasma derivatives and vaccines.
The company recently expanded globally with the U.S. market launch of Alyglo™ (IVIG) in 2024. GC Biopharma continues to advance innovation across protein engineering, mRNA, and lipid nanoparticle (LNP) drug delivery platforms—targeting therapies in rare diseases and immunology & inflammation (I&I).
