IPSC - Century Therapeutics stock gains after IND clearance for lupus candidate
2023-12-06 08:24:39 ET
Century Therapeutics ( NASDAQ: IPSC ) gained over 8% premarket on Wednesday after the U.S. Food and Drug Administration cleared its investigational new drug (IND) for CNTY-101 in systemic lupus erythematosus (SLE).
CNTY-101 is an investigational cell therapy product candidate engineered with six precision gene edits, including a CD19-CAR, Century's ( IPSC ) core Allo-Evasion technology, IL-15 cytokine support and a safety switch.
This marks second IND clearance for CNTY-101 and first in an autoimmune and inflammatory disease indication.
The company plans to initiate the Phase 1 clinical trial in the first half of 2024, with initial data expected by year-end 2024. The multi-center trial is designed to assess the safety, tolerability, pharmacokinetics, and clinical response of CNTY-101 in patients with moderate to severe SLE who have failed at least two standard immunosuppressive therapies.
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Century Therapeutics stock gains after IND clearance for lupus candidate