CABA News & Events

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 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.

"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."