PHILADELPHIA, PA — Century Therapeutics (NASDAQ: IPSC) has received approval from the U.S. Food and Drug Administration (FDA) to proceed with their Phase 1 clinical trial of CNTY-101 for patients with moderate to severe systemic lupus erythematosus (SLE). This marks the first Investigational New Drug (IND) application clearance for an autoimmune and inflammatory disease indication for CNTY-101.
CNTY-101, an allogeneic, off-the-shelf iPSC-derived NK cell product candidate, has been engineered with six genetic edits at defined loci using CRISPR. The product, which includes three Allo-Evasion™ edits, secreted IL-15, a CD19 CAR, and a safety switch allowing for cell removal if required, is designed to offer multiple potential treatment advantages. These include availability of a consistent off-the-shelf frozen product, an improved tolerability profile, ability to be re-dosed without lymphodepletion while avoiding allo-rejection of the product, and a product design that may enable the elimination of B cells to effect a decline in auto-antibodies without prolonged B cell aplasia.
Century Therapeutics’ CEO, Brent Pfeiffenberger, Pharm.D., said, “We believe the unique profile of CNTY-101, which incorporates multiple precision edits including our Allo-Evasion™ 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.”
The Phase 1 trial will 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. The trial will evaluate one to two cycles of 3 weekly doses of CNTY-101, with lymphodepletion only included prior to the first CNTY-101 infusion. The company plans to initiate the trial in the first half of 2024, with initial data expected by the end of 2024.
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