CJ Bioscience, an independent subsidiary of CJ CheilJedang's Red Bio, is accelerating the development of new microbiome drugs by promoting clinical trials of its flagship pipeline in the US.
CJ Bioscience announced today that it has submitted phase 1 and 2 clinical trial protocols (INDs) for CJRB-101, a microbiome immunotherapeutic drug, to the US Food and Drug Administration (FDA).
CJRB-101 is an immuno-anticancer target new drug candidate secured by CJ Bioscience, and was developed through various immunological reviews based on the strain library built by CJ CheilJedang.
It is listed in the European Food Safety Agency (EFSA) and has high safety for human administration. Unlike existing intestinal microorganisms, process development for mass production of pharmaceuticals is progressing, enabling long-term clinical trials for cancer patients.
Clinical trials are conducted at multiple clinical trial institutions in the United States and Korea. It plans to recruit 46 people in phase 1 and a total of 120 people in phase 2 to conduct clinical trials.
CJ Bioscience decided to simultaneously conduct clinical efficacy evaluations for head and neck cancer and skin cancer, which have high marketability and high incidence, as well as lung cancer, in order to expand the utilization of new drug candidates.
During the first half of next year, the company plans to submit a clinical trial plan to the South Korean Ministry of Food and Drug Safety and conduct clinical trials simultaneously in the US and Korea.
Meanwhile, CJ Bioscience was officially launched in January of this year to strengthen its competitiveness in the field of "Wellness," the group's future growth engine, with the goal of developing a world-class microbiome-based new drug.
