On January 4, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and autoimmune diseases, reported corporate updates and highlighted upcoming priorities for its pipeline programs in 2024 (Press release, Adicet Bio, JAN 4, 2024, View Source [SID1234638999]).

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"In 2024, we aim to make significant strides across our pipeline of differentiated gamma delta T cell therapies through our strategic and disciplined approach," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "The U.S. FDA’s IND clearance of ADI-001 in lupus nephritis marks an important milestone in maximizing the ADI-001 opportunity in the autoimmune therapeutic category that we believe it is ideally suited to address. Clinical data for ADI-001 have demonstrated B-cell depletion that mirrors the B cell depletion by autologous alpha-beta CAR T in academic clinical studies in systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathy patients. Given that gamma delta 1 T cells preferentially traffic to organs and tissues, ADI-001 is designed to target and deplete B cells in the periphery, secondary lymphoid organs, kidneys, and other organs, which is highly desirable in autoimmune diseases. ADI-001’s off-the-shelf availability and the favorable safety profile provide the potential for outpatient administration."

Mr. Schor continued: "Our internal research and development efforts are focused in areas where we believe we have a high probability of success and opportunity for significant differentiation. In our ongoing Phase 1 clinical trial of ADI-001 in relapsed or refractory NHL, we have decided to focus our current patient enrollment on the MCL population, which demonstrated the greatest clinical benefit in our June 2023 clinical update. With projected cash runway into the second half of 2025, multiple upcoming milestones, and a disciplined approach, we believe we are well-positioned to advance our pipeline of allogeneic T cell therapy candidates to address substantial unmet needs in oncology and autoimmune diseases."

Program Updates and Expected Milestones for 2024

ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell non-Hodgkin’s Lymphoma (NHL) and autoimmune diseases.

Autoimmune diseases

IND cleared for lupus nephritis. In December 2023, the FDA cleared Adicet’s IND application for ADI-001 in lupus nephritis.
Initiate Phase 1 clinical trial of ADI-001 for the treatment of lupus nephritis in the second quarter of 2024. The Company plans to initiate a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis and may provide a clinical update from the trial in the second half of 2024. Adicet expects to expand into additional autoimmune indications in the near future.
Hematologic malignancies

Focus enrollment on MCL patients in ongoing Phase 1 GLEAN study. Adicet will focus on the MCL patient population in the ongoing Phase 1 GLEAN study (at dose level 4), which experienced the greatest clinical benefit in the June 2023 update. While these were early data, an 80% CR rate and 60% 6-month CR rate in late line MCL patients were reported in the June 2023 clinical update, Cmax and exposure by area under the curve (AUC) exceeded that of approved autologous CD19 CAR T therapies, and a favorable safety profile was observed with no significant risk of cytokine release syndrome, immune effector cell associated neurotoxicity syndrome or T-cell malignancies. These initial clinical results, coupled with the potential to dose off-the-shelf in a community setting, support ADI-001 as a potentially attractive therapy for MCL patients. The Company is evaluating the option of advancing ADI-001 to a potentially pivotal study in MCL patients under an accelerated approval pathway.
The Company remains on track to provide an ADI-001 clinical update in the second half of 2024.
ADI-270 is an investigational allogeneic gamma delta CAR T cell therapy targeting CD70 via the CD27-ligand for the treatment of renal cell carcinoma with potential in other solid tumor indications. ADI-270 is designed to home to solid tumors, with a highly specific targeting moiety for CD70 and an armoring technology of TGF beta dominant- negative receptor to address immunosuppressive factors in the tumor microenvironment. Building on gamma delta 1 tissue tropism to solid tumors and three mechanisms of anti-tumor activity (CAR, innate and adaptive), CAR gamma delta 1 T cells may be well positioned to address solid tumors.

Renal cell carcinoma

Plan to file IND for ADI-270 in 2Q 2024. Following positive feedback from a pre-IND meeting with the FDA, the Company remains on track to file an IND application for ADI-270 in the second quarter of 2024.
Financial Outlook

The Company expects cash and cash equivalents on hand as of December 31, 2023, to enable funding for current and planned operations into the second half of 2025.
Webcast/ Conference Call Information

The live webcast of the presentation can be accessed by registering under "Presentations & Events" in the investors section of the Company’s website at View Source Upon registration, all participants will receive a confirmation email with a unique passcode to provide access to the webcast event. To participate via telephone, please join by dialing 888-788-0099 (domestic) or 312-626-6799 (international) and referencing the conference ID 918 2940 8885. An archived replay will be available for 30 days following the presentation. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.