ADI-001

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Adicet Bio (NasdaqGM:ACET) Earnings Call Presentation
2025-10-07 12:00
ADI-001 Clinical Data and Safety Profile - ADI-001 demonstrated rapid and sustained reductions in SLEDAI-2K and PGA across all patients with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)[5,18] - All five LN patients achieved renal responses, including three complete renal responses and Definition of Remission in Systemic Lupus Erythematosus (DORIS) remissions[5,34] - ADI-001 showed a well-tolerated safety profile, with no ≥Grade 2 Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)[5,18] - All seven patients discontinued immunosuppressants and tapered corticosteroids to zero or physiological levels[5,18] - Clear evidence of immune reset was observed, with subsequent emergence of naïve B cell repertoire following a single treatment[5,18] ADI-001 Autoimmune Program and Pipeline - Adicet Bio is developing a broad pipeline of allogeneic γδ1 T cell therapies for autoimmune diseases and cancer[8] - ADI-001 is currently in clinical trials for LN & SLE, Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)/Stiff Person Syndrome (SPS), Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis (AAV), and Rheumatoid Arthritis (RA)[8] - Adicet Bio anticipates SLE and LN clinical updates in the first half of 2026 and plans to initiate a pivotal study in LN or LN/SLE in the same period[11] ADI-212 Oncology Program - ADI-212, a PSMA-targeted therapy, is planned for regulatory filing in the first quarter of 2026, with initial clinical data expected in the second half of 2026 for metastatic castration-resistant prostate cancer (mCRPC)[8] Financial Status - As of June 30, 2025, Adicet Bio had approximately $125 million in cash and cash equivalents[12]
Adicet Bio (ACET) Earnings Call Presentation
2025-06-25 09:28
ADI-001 for Autoimmune Diseases - Adicet's ADI-001 targets CD20 and has demonstrated complete CD19+ B cell depletion in blood and secondary lymphoid tissue[8, 17] - ADI-001 is under clinical development for 6 autoimmune indications, with initial clinical data expected in the second half of 2025[8, 9] - ADI-001's Cmax, D28 Persistence, and AUC are consistent with approved autologous CD19 CAR T therapies[19] - In preclinical studies, ADI-001 exhibited potent killing of patient-derived CD19+ B cells in multiple autoimmune diseases, including SLE, SSc, RA, Multiple Sclerosis, and Sjogren's Syndrome[25] - A Phase 1 autoimmune study is underway, with primary endpoints focused on safety and secondary endpoints including cellular kinetics, pharmacodynamics, and efficacy endpoints specific to each indication[57, 59] - The company is expanding ADI-001 autoimmune development across six indications with a US prevalence of ~242 thousand patients for SLE, ~85 thousand for Systemic Sclerosis, ~60 thousand for IIM, ~60 thousand for AAV and so on[50, 51] ADI-270 for Oncology - Adicet's ADI-270 targets CD70 and is designed to address multiple refractory cancers, with a Phase 1 clinical update expected in the second half of 2025[8, 62, 64] - ADI-270 incorporates a TGFβ receptor II to mitigate immunosuppressive effects and is engineered to increase persistence[8, 65] - Preclinical data shows ADI-270 retains potent activity in CD70-low tumors compared to clinically relevant CD70-targeting αβ CAR T cell benchmarks[79] - In ccRCC xenograft models, a single dose of ADI-270 demonstrated potent regression and sustained systemic anti-tumor activity[92] Financial Status - As of March 31, 2025, Adicet Bio has approximately $1504 million in cash and cash equivalents, projected to provide a cash runway into the second half of 2026[101]