- 7 out of 8 myositis patients achieved clinically meaningful responses after discontinuing immunomodulators and steroids.
- All SLE patients without nephropathy achieved remission, and both scleroderma patients showed significant skin improvements.
- 94% of patients showed no or mild cytokine release syndrome (CRS), and 89% experienced no ICANS.
Cabaletta Bio (CABA, Financial) has presented promising new clinical data for their investigational therapy, rese-cel (resecabtagene autoleucel), at the EULAR 2025 Congress. The data showcased strong efficacy across multiple autoimmune diseases, including myositis, systemic lupus erythematosus (SLE), and scleroderma.
In the clinical trials, 7 out of 8 myositis patients achieved meaningful therapeutic responses, and all non-nephropathy SLE patients reached remission while off immunomodulators and steroids. Notably, both patients with scleroderma demonstrated significant skin condition improvements.
Regarding safety data from 18 patients, 94% experienced either no or Grade 1 CRS, and 89% had no immune effector cell-associated neurotoxicity syndrome (ICANS). These results underline the favorable safety profile of rese-cel.
The company is making strides in its RESET clinical program, which has enrolled 51 patients, with 24 already dosed across various clinical sites. Cabaletta Bio plans to engage in registrational discussions with the FDA for several indications: SLE/LN in Q3 2025, scleroderma in Q4 2025, and myasthenia gravis in the first half of 2026.
