On November 3, 2022 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 detailing updated safety and efficacy data from the Company’s Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL) was made available as part of the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held December 10-13, 2022 in New Orleans, Louisiana (Press release, Adicet Bio, NOV 3, 2022, View Source [SID1234623038]). The abstract outlines a summary of clinical data as of a July 15, 2022 data-cut date. Clinical data will be provided during a poster presentation by Sattva Neelapu, M.D., from the MD Anderson Cancer Center at the ASH (Free ASH Whitepaper) Annual Meeting on Saturday, December 10, 2022.
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"The latest data-cut from our ongoing study of ADI-001 is extremely encouraging, as we continue to see complete responses and preliminary durability coupled with a benign safety profile in heavily pre-treated patients with aggressive NHL. We look forward to providing additional clinical data from a later data-cut date during the ASH (Free ASH Whitepaper) Annual Meeting," said Francesco Galimi, M.D., Ph.D., Chief Medical Officer of Adicet Bio. "With the data generated to date coupled with the pace of enrollment in dose level 4, we remain on track to initiate a potentially pivotal program for ADI-001 in the first half of 2023."
Data highlights as of the July 15, 2022 data-cut date included in the ASH (Free ASH Whitepaper) abstract were as follows:
Of the nine evaluable patients, three patients were treated at each of the three dose levels: dose level 1 (DL1; 30 million CAR+ cells), dose level 2 (DL2; 100 million CAR+ cells), and dose level 3 (DL3; 300 million CAR+ cells). Two patients at DL3 were re-dosed with a second course of ADI-001, per protocol. Six of nine were male (67%) and the median age was 62 years (range 45-75). There were eight patients with large B-cell lymphoma (LBCL) and one with mantle cell lymphoma. Of the eight patients with LBCL, five had diffuse-large B-cell lymphoma (DLBCL), two had high-grade B-cell lymphoma (HGBCL) with double/triple hit, and one had HGBCL not otherwise specified. Indolent lymphomas, such as follicular lymphoma, are currently excluded from the study.
Overall, the patients were heavily pretreated with a median number of prior therapies of four (range 2-5), and had a poor prognostic outlook as indicated by the median International Prognostic Index (IPI) score of four (range 2-4); the median tumor burden was 2,974 (150-7,919) mm2, and 89% (8/9) had stage III/IV disease.
The best overall response rate (ORR) and complete response rate (CR) was 78% (7/9). For the four patients who had prior autologous CD19 CAR T therapies, the ORR and CR rate was 100% (4/4). As of the data-cut date, of the seven patients who had achieved CR, two patients progressed, one died of unrelated causes while in complete remission and four were still in CR and in active follow up, with a range of follow-up time between 1.2 and 8.8 months.
CAR+ gamma delta T cell kinetics in the peripheral blood increased in a dose-dependent manner with peak cell expansion occurring between Days seven and 10 at DL3 based on flow cytometry.
Of the nine patients, there were no ≥ Grade 3 Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) events. Two patients developed CRS: one Grade 1 and one Grade 2. At the time of the ASH (Free ASH Whitepaper) abstract submission, there were three reported related serious adverse events: Grade 2 CRS, Grade 1 ICANS and Grade 3 adenoviraemia. There was no reported graft versus host disease or protocol-defined dose-limiting toxicity events.
Response data were evaluated per Lugano 2014 criteria by independent radiographic review.
The full abstract is available online on the ASH (Free ASH Whitepaper) website.
Clinical data will be presented during a poster presentation by Sattva Neelapu, M.D. at the ASH (Free ASH Whitepaper) Annual Meeting on Saturday, December 10, 2022 from 5:30 – 7:30 p.m. CT. Adicet will provide data from a more recent data-cut date from the Phase 1 study in a press release and company webcast on Sunday, December 11, 2022 at 8:00 a.m. CT/ 9:00 a.m. ET.
Details of the poster presentation are as follows:
Session Title: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Title: A Phase 1 Study of ADI-001: Anti-CD20 CAR-Engineered Allogeneic Gamma Delta1 (γδ) T Cells in Adults with B-Cell Malignancies
Presenting Author: Sattva Neelapu, M.D., MD Anderson Cancer Center
Date/Time: Saturday, December 10, 2022 from 5:30 – 7:30 p.m. CT.
Adicet ADI-001 Webcast Information
The Company will host a webcast event on Sunday, December 11, 2022, at 8:00 a.m. CT/ 9:00 a.m. ET to discuss recent data from its ongoing Phase 1 clinical study of ADI-001 in relapsed or refractory aggressive B-cell NHL.
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. In April 2022, 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
This 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. The study is expected to enroll approximately 75 patients. For more information about the clinical study design, please visit www.clinicaltrials.gov (NCT04735471).