PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) recently presented encouraging clinical data for its investigational therapy, CABA-201, at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C. The data, covering eight patients from ongoing Phase 1/2 RESET clinical trials, indicate the potential for achieving drug-free clinical responses in patients with refractory autoimmune diseases.
The trials demonstrated a favorable safety profile for CABA-201, with no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported in most cases. Low-grade CRS was observed in three patients, who all recovered with standard care. CABA-201 has shown consistent and complete depletion of B cells, with early signs of B cell repopulation, suggesting an immune system reset without chronic immunosuppressive therapy.
Dr. David J. Chang, Chief Medical Officer of Cabaletta, highlighted the significance of these findings. “The clinical data support the potential of CABA-201 to offer immunosuppressant-free responses in patients with active autoimmune disease,” he said. “Our expanding clinical program and upcoming discussions with the FDA aim to accelerate bringing this therapy to patients.”
CABA-201, a CD19-CAR T cell therapy, is designed to deplete CD19-positive B cells transiently and deeply, potentially leading to long-lasting remission. The RESET program, spanning multiple autoimmune conditions, continues to recruit patients across 40 U.S. sites, with plans to expand into Europe in 2025.
Clinical outcomes from the trials are promising. In the RESET-Myositis trial, a patient with dermatomyositis showed muscle strength improvement and significant score reductions, remaining off immunosuppressants. In the RESET-SLE trial, lupus nephritis patients reported clinical improvements, including reduced proteinuria and SLEDAI scores. The first systemic sclerosis (SSc) patient demonstrated early clinical benefits without disease-specific therapy.
Cabaletta Bio is planning further studies to solidify these findings and meet with the FDA to discuss potential trial designs, aiming to advance CABA-201’s development for broader patient access.
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