Century Therapeutics presents initial data from CNTY-101 Phase 1 ELiPSE-1 trial

Century Therapeutics announced the presentation of initial clinical data from a single-patient case study which Century believes support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion edits at the 65th American Society of Hematology Annual Meeting and Exposition, being held December 9-12 in San Diego. Data featured in a single-patient case study presented at ASH involves a 63-year-old patient with relapsed/refractory progressive follicular lymphoma previously treated with four prior lines of therapy who was enrolled at Dose Level 1. As of a data cutoff date of November 13, 2023, the patient has received seven 28-day cycles of a single infusion of CNTY-101 at Dose Level 1. Cycles one and two included three days of lymphodepletion, whereas cycles three through seven were given with no LD. Interleukin-2 was administered for all cycles except for the first. The patient maintained a complete response with a duration of six months before subsequently progressing. Data from the single-patient case study indicated that CNTY-101 was generally well tolerated in this patient at Dose level 1. No dose-limiting toxicities, cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome were observed, and no adverse events related to treatment with CNTY-101 were detected in this patient, to date. Additionally, no concerted changes in inflammatory cytokines and mediators associated with cytokine release syndrome or neurotoxicity have been detected in this patient. Following administration of two cycles with and three cycles without LD, serum assessments from available data of the first five cycles of CNTY-101 treatment in this patient showed no evidence of functional pre-existing or induced humoral immunogenicity against CNTY-101. Importantly, tumor microenvironment initial analyses demonstrated a vigorous increase in T cells within 8 days of the 1st CNTY-101 cell infusion. Increases in proliferating cytotoxic T cells and TNFalpha and IFNgamma-secreting cells were observed, suggestive of induction of adaptive immune responses within the tumor. Additionally, ddPCR analysis of CNTY-101 genomic DNA and cell-free DNA from Dose Level 1 patient samples suggest that CNTY-101 cells were able to traffic out of circulation shortly after infusion and showed persistence in tissues for at least 3 days.