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Century Therapeutics Receives FDA Clearance of IND Application for CNTY-101 in Systemic Lupus Erythematosus
– Represents second IND clearance for CNTY-101, the Company’s lead iPSC-derived CD19-targeted CAR NK cell product candidate, and first in an autoimmune and
About this update from Century Therapeutics, Inc.
[{"type":"text","content":"– Represents second IND clearance for CNTY-101, the Company’s lead iPSC-derived CD19-targeted CAR NK cell product candidate, and first in an autoimmune and inflammatory disease indication – – Company plans to initiate the Phase 1 clinical trial in the first half of 2024; initial data expected by year-end 2024 – – CNTY-101 is the first cell therapy product candidate engineered with six precision gene edits including a CD19-CAR, Allo-Evasion™ technology, IL-15 cytokine support and a safety switch – PHILADELPHIA, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced that the Company has been notified by the U.S. Food and Drug Administration (FDA) that the Company’s Phase 1 clinical trial may proceed to assess CNTY-101 in patients with moderate to severe systemic lupus erythematosus (SLE) who have failed at least two standard immunosuppressive therapies. This represents the first Investigational New Drug (IND) 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. Despite recent advances, therapies for SLE have failed to make a significant impact on morbidity, and induction of remission remains rare, while treatment toxicity and disease flares are common. B-cell-directed autologous CAR T cell therapies have provided new hope for durable remissions through an “immune reset”. However, some of the challenges encountered with auto-CAR-T in oncology related to product availability, toxicities, and potential long-term risks could hamper their wide-spread adoption in non-oncology indications. Century is pursuing an alternative approach with CNTY-101, an allogeneic, off-the-shelf iPSC-derived NK cell product candidate. CNTY-101 contains 6 genetic edits at defined loci, engineered via homology directed repair using CRISPR. These include three Allo-Evasion™ edits, secreted IL-15, a CD19 CAR, and a safety switch allowing for cell removal if required. As a homogenous NK cell candidate derived from a sing...