Clinical Remission
-
Fate Therapeutics Presents FT819 CAR T-Cell Data Demonstrating Immune Remodeling and Durable Responses in Systemic Lupus Erythematosus Patients at ACR Convergence 2025
Fate Therapeutics reported positive Phase 1 data for FT819, an off-the-shelf CAR T-cell therapy, in ten treatment-refractory SLE patients. A single dose resulted in rapid B-cell depletion and immune remodeling. The study showed durable clinical responses, including complete renal responses and steroid-free remission. FT819 demonstrated a favorable safety profile with low-grade CRS and no ICANS or GvHD. The data support potential outpatient administration and a pivotal study in 2026. These results suggest FT819’s transformative potential for SLE treatment.
-
Abivax to Present Late-Breaking ABTECT Trial Results and Updated Safety Data
Abivax (ABVX) reported positive Phase 3 ABTECT trial results for obefazimod in ulcerative colitis. A pooled analysis showed a 16.4% placebo-adjusted clinical remission rate at Week 8 with the 50mg dose, meeting the FDA primary endpoint. Trials enrolled a refractory population, including patients who failed advanced therapies or JAK inhibitors. No new safety signals for serious infections or malignancies were reported. Headache and nausea were common adverse events. Analysts believe efficacy in the difficult-to-treat patient group could position obefazimod favorably in the market.
