Business
Cabaletta Bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
– Company expecting Investigational New Drug (IND) clearance in the first half of 2023 for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell therapy,
About this update from Cabaletta Bio, Inc.
[{"type":"text","content":"– Company expecting Investigational New Drug (IND) clearance in the first half of 2023 for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell therapy, with potential to generate initial clinical data by the first half of 2024 – PHILADELPHIA, March 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 reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update. “As we seek FDA clearance for CABA-201 in the next few months, we believe that our specifically designed product candidate for autoimmune patients, our experience with efficient autoimmune cell therapy clinical trial design coupled with timely implementation of complicated autoimmune cell therapy trials and our exclusive translational research partnership with Georg Schett, M.D., which is currently delivering actionable clinical insights, provide us with the opportunity to deliver potentially transformative outcomes for patients with a broad range of autoimmune diseases,” said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. “In parallel, we continue to make progress on our pipeline of clinical-stage CAART legacy product candidates, with 1-month safety and persistence data for the combination sub-study in the DesCAARTes™ trial for DSG3-CAART anticipated in the first half of 2023 and recruitment in the MusCAARTes™ trial for MuSK-CAART ongoing. Looking ahead, we are confident in our ability to advance our autoimmune-focused pipeline for patients with serious unmet need and deliver on multiple upcoming value-creating milestones.” Recent Operational Highlights and Upcoming Milestones Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) Strategy CABA-201: Autologous, engineered T cells with a chimeric antigen receptor containing a fully human CD19 binder and a 4-1BB co-stimulatory domain as a potential treatment for a broad range of autoimmune diseases where B cells contribute to the initiation and/or maintenance of disease. Unveiled new development candidate, CABA-201, a 4-1BB containing CD19-CAR T cell therapy product candidate for autoimmune diseases: On October 11, 2022, Cabaletta announced CABA-201, a ...