Cabaletta Bio presents Phase 1/2 data showing durable responses across four autoimmune diseases
Cabaletta Bio reported Phase 1/2 results for its CAR‑T cell therapy rese‑cel in 71 patients with dermatomyositis, lupus nephritis, systemic sclerosis and interstitial lung disease. All six dermatomyositis patients and all five lupus nephritis patients achieved immunomodulator‑free remission, while five of seven systemic sclerosis patients reached the rCRISS‑50 endpoint and the five ILD patients showed a 9% mean FVC gain. The company said safety was favorable, with 94% of patients experiencing no cytokine release syndrome or only Grade 1 events, and plans a Biologics License Application in the first quarter of 2028. The news lifted CABA shares about 12% in pre‑market trading.
Why it matters
The data suggest a strong benefit‑risk profile that could accelerate regulatory approval, potentially expanding Cabaletta’s market and revenue. The company’s stated intent to file a BLA in Q1 2028 gives investors a concrete timeline for a commercial milestone. The immediate share price jump reflects market optimism about the upcoming filing.
Key facts
- 171 patients were treated across four autoimmune diseases as of the September 4, 2026 data cut‑off. investing.com
- 2100% (6/6) of dermatomyositis patients maintained an immunomodulator‑free Total Improvement Score response through one year. rttnews.com
- 3100% (5/5) of lupus nephritis patients achieved immunomodulator‑free DORIS remission and histologic response. rttnews.com
- 471% (5/7) of systemic sclerosis patients achieved immunomodulator‑free rCRISS‑50 at one year. rttnews.com
- 5The five systemic sclerosis patients with interstitial lung disease showed a 9% mean forced vital capacity improvement at one year. rttnews.com
- 694% of patients experienced no cytokine release syndrome or only Grade 1 events; 6% reported Grade 2 events, and 96% had no neurotoxicity. investing.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.