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Cabaletta Bio Receives FDA Clearance of IND Application for CABA-201 for Treatment of Myositis
– Phase 1/2 trial for CABA-201 planned to initiate in patients with myositis at an initial dose that is equivalent to the dose used in a patient with myositis
About this update from Cabaletta Bio, Inc.
[{"type":"text","content":"– Phase 1/2 trial for CABA-201 planned to initiate in patients with myositis at an initial dose that is equivalent to the dose used in a patient with myositis as reported in the recent Lancet Rheumatology publication – – Second IND clearance for CABA-201, obtained within two months of first IND clearance in systemic lupus erythematosus (SLE) – PHILADELPHIA, May 16, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company’s second Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been cleared by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with active idiopathic inflammatory myopathy (IIM, or myositis). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 for the treatment of six patients with dermatomyositis (DM), six patients with anti-synthetase syndrome (ASyS), and six patients with immune-mediated necrotizing myopathy (IMNM), all in separate parallel cohorts. The initial dose for the trial, 1 x 106 cells/kg, was informed by preclinical data evaluating the binder in CABA-201 and the binder used in the CD19-CAR T construct administered to a patient with myositis in the recent Lancet Rheumatology publication. “The clearance of our second IND application for CABA-201 within two months of the first IND clearance in SLE allows us to initiate a clinical trial in patients with myositis and underscores the efficiency of our organization along with the value of our experience in the development of cellular therapies for patients with autoimmune diseases,” said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. “Similar to our Phase 1/2 trial design in SLE, this clinical trial will include patients with several different subtypes of myositis where B cells may be involved in disease pathology. With an experienced team well-versed in conducting autoimmune-focused cell therapy trials, and a product candidate specifically engineered for patients with autoimmune diseases, we look forward to evaluating the potential for CABA-201 to change the treatment paradigm for patients with autoimmune dise...