Cabaletta Presents 50% PC-Free Rese-cel Response, Secures 10-Year Supply Deal
Cabaletta Bio presented six-to-nine-month PC-free data showing 50% drug-free clinical responses in four pemphigus vulgaris patients treated with the lowest rese-cel dose and demonstrated comparable CAR T expansion in two Cellares-manufactured doses. The company also secured a 10-year Cellares supply agreement and aims for a 2027 BLA submission in myositis.
1. Q1 Financial Results and Business Update
Cabaletta Bio reported results for the quarter ended March 31, 2026, reaffirming its cash runway supported by an oversubscribed financing and outlined its continued focus on advancing rese-cel through clinical and manufacturing milestones.
2. ASGCT 2026 PC-Free Clinical Data
At the ASGCT 2026 Annual Meeting, Cabaletta presented six-to-nine-month data from the lowest PC-free rese-cel cohort in pemphigus vulgaris, showing drug-free responses in two of four patients and initial translational data from two Cellares-manufactured doses with equivalent CAR T expansion and B cell depletion.
3. Cellares Manufacturing Partnership
In April 2026, Cabaletta signed a 10-year commercial supply agreement with Cellares to utilize the automated Cell Shuttle platform and future Cell Q system, targeting production of thousands of rese-cel batches per year at among the lowest per-batch cost in autologous cell therapy.
4. Registrational Trials and BLA Timeline
Enrollment is progressing in the 17-patient RESET-Myositis single-arm trial, which features a 16-week primary endpoint to support a planned BLA submission in myositis in 2027, while initial data from the RESET-SLE lowest dose cohort is expected in 1H26 and additional trial design updates are due mid-2026.