CJ Bioscience to Present Preclinical Data on Inflammatory Bowel Disease Pipeline Candidate CJRB-201 at 'ECCO 2025'; Clinical Entry Targeted for 2026

• 'CJRB-201', a proprietary strain of Faecalibacterium with potent its anti-inflammatory effects, has demonstrated the strongest induction of regulatory T cells (Tregs) among analyzed strains.
• Preclinical studies in multiple animal models confirm significant improvements in key disease indicators, including inhibition of weight loss and improvement in disease activity index.
• Offering a differentiated therapeutic option, CJRB-201 has shown preclinical efficacy comparable to a leading antibody-based therapy while providing superior safety and convenience of oral administration.

SEOUL, South Korea, Feb. 18, 2025 /PRNewswire/ -- CJ Bioscience announced today that it will present preclinical data on its novel drug candidate CJRB-201 at the European Crohn's and Colitis Organization (ECCO) 2025, set to take place from February 19 to 22 in Berlin, Germany. ECCO is a leading international conference in the field of inflammatory bowel disease (IBD), attracting gastroenterologists, researchers, and major pharmaceutical companies from around the world.

CJRB-201 is a microbiome-based drug candidate identified through CJ Bioscience's AI-powered drug discovery platform, Ez-Mx®, and is being developed for the treatment of inflammatory bowel disease (IBD). The company has selected  CJRB-201 as the next drug candidate following its oncology lead asset, CJRB-101, and will present its anti-inflammatory effects and mechanism of action at ECCO 2025 supported by immunological analysis and preclinical animal studies.

CJ Bioscience analyzed 500 metagenomic datasets from both IBD patients and healthy individuals and found that CJRB-201, the bacterial strain of Faecalibacterium, was significantly reduced in IBD patients compared to healthy individuals. Faecalibacterium is a key commensal bacterium in the gut, and its depletion has been closely linked to Crohn's disease and autoimmune disorders, making it a promising therapeutic target.

Among 60 Faecalibacterium strains analyzed, CJRB-201 exhibited the strongest ability to induce regulatory T cells (Tregs), which play a critical role in mitigating immune dysregulation. In mouse models, CJRB-201 significantly improved key disease markers, including inhibition of weight loss, reduction in disease activity index, histopathological improvement, suppression of pro-inflammatory cytokine secretion, and improvement of colon length. Notably, CJRB-201 demonstrated comparable efficacy to an antibody-based therapy in a preclinical model while offering additional advantages in safety and oral convenience.

A CJ Bioscience representative stated, "Current treatments for inflammatory bowel disease primarily rely on antibody therapies, which face limitations in long-term use due to their inconvenience and safety concerns. CJRB-201 offers a novel treatment approach, potentially providing antibody-like efficacy with the added benefits of a well-tolerated oral formulation." The company also announced its plan to initiate its first-in-human study in 2026 based on the promising preclinical results.

Furthermore, CJ Bioscience is conducting research to maximize the therapeutic potential of CJRB-201 by exploring dietary fibers and mechanisms of action (MoA). The company is utilizing the SHIME (Simulator of the Human Intestinal Microbial Ecosystem) system to identify dietary fibers that promote CJRB-201 colonization in the gut. Additionally, it is collaborating with Professor Jun Huh's research team at Harvard Medical School to further elucidate CJRB-201's MoA, aiming to overcome the limitations of existing microbiome-based therapeutics and accelerate CJRB-201's development.

About CJ Bioscience, Inc.

CJ Bioscience, Inc. ("CJ Bioscience" or "we") is at the forefront of developing next-generation biopharmaceuticals for microbiome health, leveraging its cutting-edge expertise in the field of "Wellness." Through our AI-driven microbiome science and technology, we strive to address unmet medical needs by exploring the intricate relationships between human microbiomes and various diseases. Our microbiome-based therapeutics program focuses on oncology (including NSCLC and melanoma), inflammatory bowel disease, and more.

Founded in 2022, CJ Bioscience is a subsidiary of CJ Group and is listed on the KOSDAQ market under the code "311690.KQ." Headquartered in Seoul, Korea, we are committed to advancing health and wellness through innovative solutions. For more information, please visit https://www.cjbioscience.com/en/.

About CJ Group

Founded in 1953, CJ Group is a global lifestyle company headquartered in South Korea dedicated to promoting the values of health, happiness and convenience through its products and services. CJ strives to transform global industries through innovation in each of its four core business areas: Food and Food Services, Bio, Logistics & Retail, and Entertainment & Media. From the delicious and healthy meals provided by renowned food brand bibigo to the world-class entertainment developed by CJ ENM, CJ maintains a commitment to its ONLYONE standard. Through the constant pursuit of forward-thinking solutions, CJ is committed to helping consumers around the world live life to the fullest. For more information, please visit https://en.cj.net/

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