On December 10, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported that an abstract outlining PK and PD profiling data from the Company’s ongoing Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory aggressive B-cell NHL was made available as part of the 65th ASH (Free ASH Whitepaper) Annual Meeting, being held December 9-12, 2023 in San Diego, California (Press release, Adicet Bio, DEC 10, 2023, View Source [SID1234638394]). The data will be provided during a poster presentation at the ASH (Free ASH Whitepaper) Annual Meeting on Sunday, December 10, 2023.

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"We are pleased to share encouraging observations from the pharmacokinetic and pharmacodynamic analyses of ADI-001 at ASH (Free ASH Whitepaper), further characterizing its potential as a best-in-class allogeneic CAR T platform. The data presented today showed dose-dependent expansion and persistence that met or exceeded that in prescribing information of approved autologous CD19 CAR T therapies, supporting ADI-001’s potential as an effective therapeutic option for patients with advanced cancers," said Francesco Galimi, M.D., Ph.D., Chief Medical Officer. "Historically, expansion and persistence of cell therapy products and release of functional cytokines have correlated with patient outcomes. We remain on track to provide a clinical update from the Phase 1 study in NHL patients in the second half of 2024."

Data highlights included in the ASH (Free ASH Whitepaper) presentation were as follows:

Robust dose-dependent expansion and persistence of ADI-001 were observed using three different methodologies for measuring exposure.
ADI-001 displayed a strong exposure profile and was positively associated with both PD correlates and clinical response, as supported by the following:
At DL3 and DL4, ADI-001 Cmax and Tmax that met or exceeded that in prescribing information of approved autologous CD19 CAR T therapies.
Increasing dose levels showed higher Cmax and AUC and were associated with patient clinical responses.
ADI-001 stimulation and proliferation were associated with peak levels of CAR+ cells and higher production of polyfunctional cytokines, particularly in patients whose best overall response was complete response or partial response.
Elevating levels of endogenous cytokines, comprising stem cell factor and IL-15, may potentially contribute to increased ADI-001 expansion and clinical response.
ADI-001 exposure or clinical response showed no correlation with the degree of shared HLA alleles between patient and ADI-001.
Details of the poster presentation are as follows:

Title: Expansion, Persistence and Pharmacodynamic Profile of ADI-001, a First-in-Class Allogeneic CD20-Targeted CAR Gamma Delta T Cell Therapy, in Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma
Poster Number: 3478
Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
Presenting Author: Monica Moreno, Ph.D.
Date/Time: Sunday, December 10, 2023, from 6:00 – 8:00 p.m. PST
About ADI-001

ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy being developed as a potential treatment for relapsed or refractory B-cell NHL. ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent antitumor activity in preclinical models, leading to long-term control of tumor growth. ADI-001 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed or refractory B-cell NHL.

About the GLEAN Study

The Phase 1 study is an open-label, multi-center study of ADI-001 enrolling adults diagnosed with B-cell malignancies who have either relapsed, or are refractory to, at least two prior regimens. The primary objectives of the study are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ADI-001, and to determine optimal dosing as a monotherapy. For more information about the clinical study design, please visit www.clinicaltrials.gov (NCT04735471).