Century Therapeutics receives FDA clearance of IND-application for CNTY-101

Century Therapeutics announced that the Company has been notified by the U.S. Food and Drug Administration that the Company’s Phase 1 clinical trial may proceed to assess CNTY-101 in patients with moderate to severe systemic lupus erythematosus who have failed at least two standard immunosuppressive therapies. This represents the first Investigational New Drug application clearance for an autoimmune and inflammatory disease indication for CNTY-101, and is built on the emerging data and experience gained from administering multiple cycles of CNTY-101, with and without lymphodepletion, under the open IND for CNTY-101 in relapsed/refractory B-cell malignancies. “Today marks an important milestone in Century’s evolution as a company. We believe the unique profile of CNTY-101, which incorporates multiple precision edits including our Allo-Evasion(TM) technology, positions it as an off-the-shelf allogeneic treatment option that could meaningfully improve outcomes for patients with SLE for whom existing therapies fall short,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. “The expansion of the CNTY-101 program into SLE represents a significant achievement for the Company, and, importantly, serves as a testament to the unwavering dedication of our team as we continue to execute on our mission to advance differentiated and potentially curative cell therapies to patients with cancer and autoimmune and inflammatory diseases.”