PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) shared new and updated results from its RESET clinical development program at major scientific conferences, presenting data on the first 10 patients treated with resecabtagene autoleucel (rese-cel) for autoimmune diseases. These findings indicate strong efficacy, a favorable safety profile, and the potential for drug-free remission in patients with severe, refractory conditions.
Promising Clinical Outcomes
Cabaletta’s RESET program spans six Phase 1/2 trials, targeting conditions in rheumatology, neurology, and dermatology. Among the key highlights of the data as of January 8, 2025, are remarkable advancements in patients treated across the RESET-Myositis™, RESET-SLE™, and RESET-SSc™ trials.
- Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN): Three of four non-renal SLE patients achieved DORIS (Definition of Remission in SLE) remission, while an LN patient showed a complete renal response. All patients discontinued immunosuppressants and steroids following treatment.
- Dermatomyositis: The first patient maintained major improvement in the Total Improvement Score (TIS) at three months post-infusion, reflecting the potential for drug-free remission in myositis.
- Systemic Sclerosis: A patient with severe skin involvement demonstrated meaningful skin improvements across increasing body areas paired with improved lung function.
Additionally, a lymph node biopsy in a systemic sclerosis patient confirmed tissue-resident depletion of B cells, aligning with the deep B cell depletion consistently observed across studies.
Safety Profile and Expanded Enrollment
The data continue to support rese-cel’s favorable safety profile, with 90% of patients experiencing either no cytokine release syndrome (CRS) or mild Grade 1 CRS, and no immune effector cell-associated neurotoxicity syndrome (ICANS) in 90% of patients.
Efforts to accelerate enrollment and expand the trials have seen significant success, with 50 clinical sites in the U.S. and Europe actively recruiting and 26 patients enrolled as of February 13, 2025. Chief Medical Officer David J. Chang, M.D., emphasized Cabaletta’s commitment to advancing rese-cel’s development, stating, “We believe our expanding footprint of clinical sites in the US and Europe has facilitated our ability to accelerate the pace of enrollment and dosing across the RESET program. With an average of one patient enrolling per week since November, we anticipate that we will generate sufficient data to further clarify rese-cel’s profile across multiple indications this year to rapidly deliver its therapeutic potential for autoimmune patients.”
Transforming Autoimmune Treatments
Rese-cel, a fully human CD19-CAR T cell therapy designed for transient yet profound B cell depletion, offers a unique mechanism to reset the immune response and achieve lasting remission without chronic therapy. These promising results also set the stage for FDA discussions regarding registrational trial designs in the first half of 2025.
Cabaletta Bio’s breakthroughs highlight the potential of rese-cel to transform the landscape of autoimmune disease treatment. With ambitious research and expanding trials, the company is poised to build on these early successes, aiming to deliver innovative, life-changing therapies for patients suffering from these challenging conditions.
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