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Cabaletta CEO Says rese-cel Shows Clinical Potential
"A single infusion of rese-cel has demonstrated the potential to deliver deep, clinical responses after discontinuation of all immunomodulators with up to 1.5 years of follow-up as reported in the most recent Phase 1/2 clinical experience. Continued expansion of the outpatient dosing option with rese-cel remains a top priority, and we believe the reported safety profile supports its incorporation across the RESET clinical development program," said Steven Nichtberger, Chief Executive Officer of Cabaletta. "Additionally, we view the product design and development characteristics of rese-cel, including the use of a fully-human CAR construct, weight-based dosing, and a well-characterized manufacturing process, to have contributed to the compelling clinical outcomes reported in adult and juvenile patients across multiple autoimmune diseases. As we progress rese-cel through and into registrational trials for myositis and systemic sclerosis, respectively, we are also particularly encouraged by the reported PC-free data in lupus and PV patients which have prompted us to incorporate the PC-free approach in RESET-MG."
Cabaletta Bio Announces New Clinical Data, Plans Systemic Sclerosis Study in 2026
Cabaletta Bio announced new clinical data and development updates for its cell therapy, rese-cel, across its autoimmune portfolio at the EULAR 2026 Congress. In the RESET-Myositis study, 83% of dermatomyositis patients met the registrational primary endpoint, maintaining responses off immunomodulators. Based on Phase 1/2 data, the company plans to initiate a systemic sclerosis registrational study in the fourth quarter of 2026. Additionally, early preconditioning-free data in the RESET-SLE study achieved deep B-cell depletion in one of the first two treated lupus patients at the lowest dose. Cabaletta expects to submit a biologics license application for myositis in the second half of 2027.
Cabaletta Bio Announces RESET-PV Clinical Data
Cabaletta Bio announced new clinical and translational data from the first four patients in the lowest dose cohort in RESET-PV evaluating preconditioning-free rese-cel and initial manufacturing and translational data from the first two autoimmune patients treated with rese-cel manufactured using the automated Cellares Cell Shuttle platform in the RESET clinical development program. "Based on our view that a higher rese-cel dose would be required in the absence of preconditioning, it is encouraging that at the lowest PC-free dose, which is the same dose used across the RESET program with preconditioning, 50% of the patients demonstrated compelling and drug-free responses through 6 months of follow-up. PC-free rese-cel has the potential to substantially expand access for patients in current CAR T centers on an outpatient basis as well as in community-based infusion centers," said David Chang, chief medical officer.
Cabaletta Signs Long-Term Supply Agreement to Advance Rese-cel Production
"Since January, while advancing our myositis pivotal trial and planning to initiate a second pivotal indication, we announced that we have signed a long-term commercial supply agreement with Cellares which provides the potential to produce rese-cel for thousands of patients per year at among the lowest cost of goods in the industry with minimal capital investment. In addition, today we are presenting data at ASGCT demonstrating that without preconditioning, even the lowest dose of rese-cel demonstrated compelling drug-free clinical responses in half of the pemphigus vulgaris patients through 6-months of follow-up," said Steven Nichtberger, Chief Executive Officer of Cabaletta. "Later this quarter, we expect to announce initial data from the lowest dose cohort of lupus patients dosed without preconditioning. In the second half of 2026, we expect to report longer-term, PC-free rese-cel data from the lowest dose RESET-PV and RESET-SLE cohorts as well as data from patients treated with a higher PC-free dose of rese-cel. Bolstered by our recent oversubscribed financing, we believe we are well-positioned to advance rese-cel to BLA submission and potential commercial launch while continuing to differentiate and deliver rese-cel to autoimmune disease patients at scale."
Cabaletta Bio and Cellares Sign Commercial Agreement for resecabtagene autoleucel Supply
Cabaletta Bio and Cellares announced a commercial agreement to supply resecabtagene autoleucel using Cellares' automated Cell Shuttle and through future implementation of Cellares' Cell Q platform. The companies believe Cellares' automated platforms for manufacturing and QC release can enable flexible low-cost scaling of commercial production of rese-cel to thousands of batches per year with minimal capital investment. Under the agreement, Cellares is expected to provide future commercial supply of rese-cel, pending FDA approval, using its automated manufacturing and quality control platforms. Under the terms of the agreement, Cabaletta has secured the ability to supply thousands of batches per year over a 10-year period with minimal capital investment. The companies anticipate the per batch cost to be among the lowest in the industry for autologous cell therapy production.
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