Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced new and updated clinical data on CABA-201 demonstrating the potential to achieve drug-free, compelling clinical responses based on eight patients dosed across the ongoing Phase 1/2 RESET-Myositis, RESET-SLE and RESET-SSc clinical trials. These data were presented in oral and poster presentations at the American College of Rheumatology (ACR) Convergence 2024, which is being held at the Walter E. Washington Convention Center in Washington, D.C. from November 14-19, 2024. Presentation materials featured at ACR Convergence 2024 can be accessed on the Company's website here.

"The clinical data reported at ACR Convergence this weekend support the potential of the current dose of CABA-201 to provide immunosuppressant-free, compelling clinical responses in patients with active, refractory autoimmune disease. Data presented from the previously reported patient with lupus nephritis who experienced ICANS and had acute inflammatory events shortly before CABA-201 treatment demonstrated an abnormal, pro-inflammatory cytokine profile prior to and after CABA-201 infusion, suggestive of an occult infection. As a result of these data, subjects in the RESET clinical program who develop a fever prior to scheduled infusion will wait a minimum of two weeks before administration of CABA-201. Other than this patient with a second, later peak expansion, CABA-201 displayed a consistent PK and PD profile in all other patients," said David J. Chang, M.D., Chief Medical Officer of Cabaletta. "In addition to our promising clinical and translational data set from the RESET program, we believe our efficient clinical trial design, growing footprint of 40 actively recruiting U.S. clinical sites and anticipated expansion into Europe in 2025 provide us with a differentiated opportunity to accelerate development of CABA-201 for patients. Data permitting, we anticipate meeting with the FDA in 2025 to discuss potential registrational trial designs for CABA-201 that will allow us to bring the therapeutic potential of this investigational therapy closer to autoimmune patients."

Cabaletta designed CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to deeply and transiently deplete CD19-positive B cells following a one-time infusion that may enable a reset of the immune system with the potential for durable remission without chronic immunosuppressive therapies in patients with autoimmune diseases. Cabaletta is currently evaluating CABA-201 in the RESET clinical development program across five company-sponsored clinical trials that each have disease-specific cohorts with six patients per cohort. All cohorts are evaluating the same single, weight-based dose of CABA-201 at 1 x 106 cells/kg without a dose escalation requirement. Treatment with CABA-201 in each clinical trial includes a preconditioning regimen of fludarabine and cyclophosphamide, consistent with the dosing regimen used in the third-party academic studies, except for the RESET-PV trial which is evaluating CABA-201 without preconditioning.