regulatory
confidence high
sentiment positive
materiality 0.70
FDA clears IND for Century's CNTY-101 in systemic lupus erythematosus
Century Therapeutics, Inc.
- FDA notified Century that Phase 1 trial of CNTY-101 may proceed in moderate-to-severe SLE patients who failed ≥2 immunosuppressive therapies.
- This is the second IND clearance for CNTY-101 and first in autoimmune/inflammatory disease; previous IND for B-cell malignancies.
- Trial expected to start H1 2024 with initial data by year-end 2024; evaluates safety, tolerability, PK, clinical response.
- CNTY-101 is an allogeneic iPSC-derived NK cell with 6 genetic edits including CD19 CAR, Allo-Evasion, IL-15, and safety switch.