\nAdicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced positive safety and efficacy data from the Company\u2019s ongoing Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma (NHL).<\/p>\n
\n\u201cThese data are exciting and beyond what one might expect to see given that patients enrolled in the study were heavily pre-treated,\u201d said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio. \u201cAutologous CD19 CAR T therapies were studied on CAR T na\u00efve patients with a median of 3 prior lines of therapy. In contrast, the ADI-001 Phase 1 trial enrolled patients with a median of 4 lines of prior therapy and, importantly, 50% had previously progressed on autologous CAR T therapy. Despite the advanced nature of the patients at baseline in the ADI-001 Phase 1 study, at our recommended Phase 2 dose (DL4) ADI-001 demonstrated an overall CR rate of 63%, a 6-month CR rate of 25%, and in patients that had progressed following autologous CD19 CAR T therapy, the CR rate of ADI-001 was 67% with a 6-month CR rate of 33%.\u201d<\/p>\n
\nAdded Galimi, \u201cWe plan to transition the ADI-001 program into a potential pivotal Phase 2 study in post-CAR T LBCL in the first half of 2024. In addition, we expect to provide a clinical update which will include efficacy, 6-month CR rate, and safety data, from additional post-CAR T LBCL patients in the second half of 2024.\u201d<\/p>\n
\n\u201cThe autologous CD19 CAR T market is estimated to have an annual run rate in excess of $2.2 billion and is growing given recent approvals in the second line setting. Unfortunately, approximately 60-70% of these patients progress, which represents a significant unmet medical need,\u201d said Chen Schor, President and Chief Executive Officer of Adicet Bio. \u201cIn May we met with the FDA and discussed the design of our first potentially pivotal Phase 2 study with an accelerated approval pathway. We are very encouraged by these data and look forward to advancing ADI-001 into the next stage of clinical development and progressing our pipeline of novel gamma delta T cell product candidates in both hematologic malignancies and solid tumors.\u201d<\/p>\n
\nData highlights as of the May 4, 2023 data-cut date were as follows:<\/p>\n
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- \nOf the 24 efficacy-evaluable patients, 3 received ADI-001 at dose level 1 (DL1) (30 million CAR+ cells), 3 received ADI-001 at dose level 2 (DL2) (100 million CAR+ cells), 6 received ADI-001 at dose level 3 (DL3) (300 million CAR+ cells), 4 received two infusions of ADI-001 at DL3 (two doses of 300 million CAR+ cells, one on day 1 and the second dose on day 7 following a single lymphodepletion), and 8 received ADI-001 at dose level 4 (DL4) (1 billion CAR+ cells).<\/p>\n<\/li>\n
- \nPatients were heavily pretreated with a median of 4 prior lines of therapy (range 2-9), had relatively high tumor burden, and had a poor prognostic outlook based on their median International Prognostic Index (IPI) score. 50% of patients enrolled in the study had progressed on prior CAR T.<\/p>\n<\/li>\n
- \nADI-001 treatment demonstrated a 71% ORR and 63% CR rate in the study across all dose levels.<\/p>\n<\/li>\n
- \nADI-001 demonstrated an 83% ORR and 67% CR rate in heavily pre-treated patients (4 median prior lines of therapy) who had progressed on prior CAR T.<\/p>\n<\/li>\n
- \nADI-001 demonstrated a 6-month CR rate consistent with autologous CAR T when factoring number of prior lines of therapy and percent of patients enrolled in the study who progressed on prior CAR T.<\/p>\n<\/li>\n
- \nAdicet selected the recommended Phase 2 dose (RP2D) as 1 billion CAR positive cells (DL4).<\/p>\n<\/li>\n
- \nAt the RP2D (DL4) (with 4 median prior lines of therapy, 38% post-CAR T) the 6-month CR rate was 25%. At this dose level, in patients who had progressed on prior CAR T, the CR rate was 67% and the 6-month CR rate was 33%.<\/p>\n<\/li>\n
- \nThe expansion and persistence of ADI-001 at the RP2D exceed values reported for approved autologous CD19 CAR T cell therapy. DL4 demonstrated a mean Cmax of 483 cells\/ul with a mean time-to-peak at approximately day 9 and demonstrated persistence through day 28 with a mean concentration of 21 cells\/ul.<\/p>\n<\/li>\n
- \nADI-001 was generally well-tolerated in the study and there were no occurrences of dose-limiting toxicities or graft vs host disease (GvHD). Of the 24 patients evaluable for safety, there was 1 report of Grade 3 or higher CRS and 1 report of Grade 3 or higher ICANS.<\/p>\n<\/li>\n
- \nIn May, the Company completed a Type B meeting with the FDA and expects to transition the ADI-001 program into a potentially pivotal Phase 2 study in post- CAR T LBCL in the first half of 2024.<\/p>\n<\/li>\n<\/ul>\n
\nTable 1 \u2013 Summary of Phase 1 ADI-001 Preliminary Efficacy Data as of the May 4, 2023 data-cut date:<\/p>\n
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