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YONGIN, South Korea - GC Biopharma, a prominent player in the Biotechnology industry that has remained profitable over the last twelve months, announced Monday that phase 2 clinical trial results for its recombinant anthrax vaccine BARYTHRAX have been published in the international journal Vaccine.
The randomized, double-blind, placebo-controlled trial involved 240 healthy adults across five Korean hospitals and was designed to evaluate the safety and immunogenicity of the vaccine, which was jointly developed with the Korea Disease Control and Prevention Agency.
According to the company’s press release statement, the trial demonstrated that BARYTHRAX elicited antibodies that neutralized the anthrax toxin at levels exceeding the pre-defined protective threshold, suggesting potential protection against anthrax infection.
The safety assessment showed that adverse events in the vaccine group, including injection site pain, myalgia, fatigue, and malaise, were mostly mild and temporary. No acute adverse reactions or deaths were reported during the study.
BARYTHRAX is described as the world’s first recombinant protein-based anthrax vaccine. Unlike traditional methods that use live attenuated bacteria, it is produced using recombinant technology to express and purify the Protective Antigen protein from Bacillus anthracis. This development comes as InvestingPro data shows GC Biopharma’s net income is expected to grow this year, despite analysts anticipating an overall sales decline in the current year.
Dr. Nam Joong Kim, principal investigator of the clinical trial and professor at Seoul National University Hospital, called the research "a significant milestone in the development of safe and effective vaccines."
Jae-Uk Jeong, Head of R&D at GC Biopharma, stated that the domestically developed vaccine could strengthen national pandemic preparedness.
Anthrax is a zoonotic disease that can infect both humans and animals and is classified as a potential bioterrorism agent.
In other recent news, GC Biopharma has submitted an Investigational New Drug application to South Korea’s Ministry of Food and Drug Safety. The application is for a Phase 1 clinical trial of its COVID-19 mRNA vaccine candidate, GC4006A. The company intends to assess the safety and immunogenicity of the vaccine in healthy adult volunteers. If the trial is approved, GC Biopharma anticipates beginning vaccine administrations in early 2026, following approval by the end of 2025. These developments mark a significant step in the company’s efforts to contribute to COVID-19 vaccine options. The company’s focus on advancing this vaccine candidate reflects ongoing research and development in the biopharmaceutical industry.
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