Novel, next-generation S1P1 agonist currently in Phase 2 clinical development for treatment of inflammatory bowel disease
SAN DIEGO and TAICANG, China, Feb. 25, 2020 /PRNewswire/ — Connect Biopharma, a clinical-stage biopharmaceutical company focused on identifying and developing potent and specific immune modulating molecules today announced that, to date, it has received patent grants from the European Patent Office (No. EP3048103B), the United State Patent and Trademark Office (No. US10280158B2) and Japan Patent Office (No. JP6470757B2), and the Australian Patent Office (No. AU2014323822B2) for CBP-307. These issuances broadly expand Connect Biopharma’s intellectual property estate for CBP-307 beyond the patent issued by the China National Intellectual Property Administration (No. CN103450171B) in July 2015. The patents cover the composition of matter of the drug candidate and related compounds and have patent terms extending to no earlier than September 2033 for the patent issued in China and to September 2034 for the other patents.
CBP-307 is a proprietary small molecule and orally active S1P1 agonist currently in Phase 2 clinical development in patients with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease. The molecule was discovered using Connect Biopharma’s validated T cell-modulating discovery platform, which radically enhances and speeds identification of best- and first-in-class immune modulators.
In addition to the above-mentioned issued patents, Connect Biopharma has patent and patent applications covering the formulation and other aspects of CBP-307 that are likely to further extend the intellectual property protection of the drug candidate.
“These patent grants provide very strong intellectual property protection for CBP-307 and related compounds in all of our major markets”, said Dr. Zheng Wei, Co-founder and CEO of Connect Biopharma. “The successful global patent prosecution of composition of matter of CBP-307 and related compounds validates our innovative capacity and our ability to deliver highly differentiated therapeutics with strong worldwide intellectual property protection. We believe that CBP-307 has tremendous clinical and commercial potential in the treatment of IBD. Our robust patent estate for this molecule creates a significant barrier to competition and strongly positions us to capture a significant portion of the market for IBD therapies, which is projected to reach more than $20 billion globally by 2026 for ulcerative colitis and Crohn’s disease.”
CBP-307 is a novel second-generation agonist of the sphingosine-1-phosphate 1 receptor (S1P1), a G-protein coupled receptor (GPCR) that plays a central role in regulating T cell movement. Discovered using Connect’s proprietary T cell modulation screening platform, CBP-307 is the most potent S1P1 agonist reported and has excellent physiochemical properties. In two completed Phase 1 randomized, double blind, placebo-controlled studies, CBP-307 exhibited an excellent safety profile and potent T cell modulation activity as well as optimal pharmacokinetic and pharmacodynamic profiles, demonstrating best-in-class potential. Two Phase 2 studies of CBP-307 are currently ongoing to evaluate its efficacy and safety in patients with moderate-to-severe ulcerative colitis and moderate-to-severe Crohn’s disease.
About Connect Biopharma
Connect Biopharma is a clinical-stage biopharmaceutical company focused on discovery and development of novel immune modulators for the treatment of autoimmune diseases and inflammation. The company’s proprietary Immune Modulation Technology Platform is a high-throughput screening platform built on the biology of T cell function, and rapidly identifies molecules that target clinically validated disease pathways more efficiently than the traditional discovery approaches.
In addition to CBP-307, the company’s other lead drug candidate is CBP-201, a potent monoclonal antibody against IL-4Rα, a cell surface protein required for the signaling of both IL-4 and IL-13, which have significant overlapping biological activities and play key roles in inflammatory diseases mediated by type 2 helper T cells (Th2). The company is rapidly advancing CBP-201 for the treatment of a broad range of Th2 inflammatory diseases including atopic dermatitis (AD), asthma, and nasal polyps, food allergy, eosinophilic esophagitis, and chronic obstructive pulmonary disease (COPD). A Phase 1 clinical study of CBP-201 in healthy volunteers showed that the antibody was well tolerated and demonstrated pharmacokinetic and pharmacodynamic properties suggestive of best-in-class potential. In a double blind, placebo controlled, randomization Phase 1b clinical study in patients with moderate-to-severe AD, subcutaneous injection of CBP-201 SC injection (150 mg and 300 mg) weekly for four weeks led to rapid and significant improvement in skin lesion and reduction in pruritus intensity and frequency. Connect BioPharma is currently preparing to initiate a Phase 2b study in patients with moderate-to-severe AD.
The company is also advancing three preclinical programs, comprising two small molecule candidates (CBP-174 and CBP-312) and one antibody targeting IL-33 (CBP-233) as treatments for various serious inflammatory conditions.
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