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Cabaletta Bio Reports Clinical Data from the Second Dose Cohort in DesCAARTes™ Trial in Patients with mPV
• No dose-limiting toxicities (DLTs) or clinically relevant adverse events observed as of August 17 using 100 million cells in the second dose cohort
• DSG3-CAART persistence observed in all three patients in the second dose cohort during the 28 days following infusion
• Dosing initiated in third cohort at 500 million cells, with biologic activity data from the first two dosing cohorts and third cohort safety data anticipated in 4Q21
PHILADELPHIA, Aug 18, 2021 — Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced 28-day data from the second dose cohort, at the 100 million cell dose level, in the DesCAARTes™ Phase 1 clinical trial of DSG3-CAART for the treatment of patients with mucosal-dominant pemphigus vulgaris (mPV).
“We continue to be encouraged by the safety profile of DSG3-CAART in all patients dosed to date. In the second cohort, with patients receiving 100 million DSG3-CAART cells – a five-fold higher dose than the initial cohort – there were no clinically relevant adverse events or DLTs observed either acutely or in the 28-day DLT monitoring period following infusion,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta. “Similar to the first cohort, this safety profile was observed in the presence of circulating anti-DSG3 antibodies. In the absence of preconditioning, DSG3-CAART persistence was observed via quantitative polymerase chain reaction in peripheral blood samples of all three patients in the second dose cohort during the 28 days following infusion.”
In addition to assessing the safety and tolerability of DSG3-CAART, the trial is designed to evaluate early signs of efficacy through clinical outcomes, such as persistent decline in disease activity, reduction or discontinuation of immunosuppressive therapies and systemic corticosteroids, and absence of systemic rescue medication, as well as other biologic activity measures, including a persistent decline in anti-DSG3 antibody titers, indicating target engagement. “The persistence of DSG3-CAART post-infusion is also being evaluated as it may be an important indicator. We look forward to generating data on potential biologic activity, with the goal of providing a targeted and highly effective, and perhaps curative, therapy without generalized immunosuppression,” continued Dr. Chang.
The DesCAARTes™ trial has initiated dosing of patients in the third cohort at a treatment dose of 500 million DSG3-CAART cells. Cabaletta expects to announce top-line data on biologic activity from the first two cohorts as well as safety data from the 500 million dose cohort in the fourth quarter of 2021. Absent DLTs in the third cohort, a fourth dose cohort using 2.5 billion cells is also anticipated to initiate dosing this year. Cabaletta will continue to provide additional data on a cohort-by-cohort basis for the DesCAARTes™ trial as they become available.