Cabaletta Bio, Inc. (CABA), a clinical-stage biotechnology company, announced, on Tuesday, that it has presented updated clinical data from its ongoing RESET clinical development program at the 2024 American College of Rheumatology (ACR) Convergence in Washington, D.C.
The data highlighted CABA-201, an investigational 4-1BB-containing fully human CD19-CAR T cell therapy, showing promising results for patients with refractory autoimmune diseases, including lupus, myositis, and systemic sclerosis (SSc).
The majority of patients experienced no Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), with low-grade CRS observed in three patients who fully recovered.
Patients across multiple disease cohorts showed significant clinical improvement, with some achieving drug-free responses, suggesting the potential for durable remission without ongoing immunosuppressive therapy. Consistent complete B cell depletion was observed in all patients within the first month, with signs of immune system reset seen in early follow-ups.
The RESET program continues to expand, with 40 U.S. clinical sites recruiting patients and plans to extend into Europe in 2025. Cabaletta Bio is preparing for potential FDA discussions in 2025 regarding registrational trials for CABA-201.
"We are encouraged by these early results, which demonstrate CABA-201's potential to offer long-term, drug-free remission for patients with autoimmune diseases," said David J. Chang, M.D., Chief Medical Officer of Cabaletta Bio.
CABA closed Monday's trading at $2.29, up 22.46%. In premarket trading today, the stock is up by 4.80% at $2.40
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