Adicet Bio reports data from ongoing ADI-001 Phase 1 trial

Adicet Bio announced safety and efficacy data from the company’s ongoing Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory B-cell NHL. The company believes these data continue to support the potential of Adicet’s investigational gamma delta CAR T cell therapy to provide significant benefit both in terms of anti-tumor activity and safety. Based on the study findings as of a December 5, 2022 data-cut date, Adicet plans to transition ADI-001 into a potentially pivotal program in the second quarter of 2023. Of the 16 evaluable patients, three received ADI-001 at dose level 1, three received ADI-001 at DL2, three received ADI-001 at DL3, one received two infusions of ADI-001 at DL3, and six received ADI-001 at DL4. On an exploratory basis, primarily to understand safety and pharmacokinetics of a second ADI-001 dose, the first and second patient in DL3 while testing negative for minimal residual disease and in CR, received a second DL3 dose, three and two months after the first infusion, respectively. Patients were heavily pretreated with a median number of prior therapies of four and had a poor prognostic outlook based on their median International Prognostic Index score. ADI-001 treatment demonstrated a 75% ORR and 69% CR rate in the study across all dose levels. In five LBCL patients that previously relapsed after prior autologous anti-CD19 CAR T therapy, treatment with ADI-001 demonstrated 100% ORR and CR rate. These patients included a triple-hit high-grade B-cell lymphoma patient, three diffuse large B-cell lymphoma patients, and a double-hit high-grade B-cell lymphoma patient. ADI-001 resulted in CR in patients who previously showed a partial response to autologous CAR T. An 86% CR rate was observed in LBCL patients across DL3 and above. 75% CR rate in LBCL across all dose levels. Both DL2 and DL3 demonstrated a six-month CR rate of 33%; Patient follow up continues in DL4 to assess six-month durability. Circulating ADI-001 cells were visible through day 28 in peripheral blood at DL4. ADI-001 was generally well-tolerated in the study to date. There were no occurrences of dose-limiting toxicities, graft vs host disease, or Grade 3 or higher Cytokine Release Syndrome or immune effector cell-associated neurotoxicity syndrome reported. Enrollment in the Phase 1 clinical study of ADI-001 is currently ongoing to provide additional durability data and further support the recommended Phase 2 dose.