On January 7, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported corporate updates and highlighted upcoming milestones for 2026.
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"Heading into 2026, we are proud of the strong execution across our pipeline. Since reporting data in October from our prula-cel Phase 1 program in autoimmune diseases, enrollment has more than doubled with over 20 patients as of December 31, 2025. We have also reached regulatory alignment with the FDA to enable outpatient dosing of SLE and LN patients receiving prula-cel and are advancing our Phase 1 study in treatment-refractory RA comparing prula-cel following cyclophosphamide alone versus cyclophosphamide/fludarabine conditioning. Taken together, these accomplishments set the stage for a meaningful data readout expected in the first half of 2026," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "In parallel, we continue to advance our broader pipeline, including ADI-212, our next-generation, gene-edited and armored solid tumor candidate, which is advancing towards a regulatory filing in the first half of 2026. These achievements strongly position us as we prepare for a pivotal study and continue to advance our pipeline."
Recent Pipeline Progress and Operational Progress:
Autoimmune Diseases Clinical Programs
The prula-cel Phase 1 program is enrolling patients across seven different autoimmune diseases: LN, SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS), AAV and treatment-refractory RA. Prula-cel has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement, and SSc.
In November 2025 the Company reached alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials.
In October 2025, Adicet announced the dosing of the first treatment-refractory RA patient in a Phase 1 study. The study will evaluate two conditioning regimens: cyclophosphamide alone and cyclophosphamide with fludarabine. The primary objectives of the study are to evaluate the safety and tolerability of prula-cel. Secondary objectives include measuring cellular kinetics, pharmacodynamics, and disease activity scores.
In October 2025, the Company reported positive preliminary safety and efficacy data from the Phase 1 clinical trial of prula-cel in patients with LN and SLE. The data highlighted rapid and sustained reductions in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score and Physician’s Global Assessment (PGA), improved renal function, and favorable safety and tolerability profile as of the August 31, 2025 data cut-off date.
Solid Tumor Clinical Programs
Adicet is continuing to advance preclinical development of ADI-212, a next-generation gene-edited and armored clinical candidate designed to target prostate-specific membrane antigen. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment.
In October 2025, Adicet presented preclinical data from ADI-212 at the 32nd Annual Prostate Cancer Foundation Scientific Retreat supporting its design elements and functional enhancements in multiple models of disease.
Corporate Updates
In October 2025, Adicet successfully raised approximately $74.8 million in net proceeds through an underwritten registered direct offering of equity securities, extending its cash runway into the second half of 2027.
Strategic Priorities and Anticipated Key Milestones for 2026
Present new and updated clinical data from the Phase 1 study evaluating prula-cel throughout 2026.
Adicet remains on track to share a clinical update in LN, SLE, and SSc in the first half of 2026.
The Company also expects to share another clinical update from the study in the second half of 2026.
Gain alignment with the FDA on a path to registration for prula-cel.
Adicet plans to request a meeting with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate a pivotal study in LN or LN and SLE patients in the second half of 2026.
Advance innovations designed to enhance patient experience and expand access.
The Company is actively enrolling patients with treatment-refractory RA in its Phase 1 study of prula-cel evaluating the potential to reduce the need for conditioning.
Adicet expects to provide a clinical update on the Phase 1 RA study in the second half of 2026.
Initiate clinical development of ADI-212 in mCRPC.
Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the first half of 2026.
Subject to regulatory clearance to proceed with a clinical trial, the Company expects to initiate clinical startup activities in the second quarter of 2026.
(Press release, Adicet Bio, JAN 7, 2026, View Source [SID1234661828])