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Adicet Bio (NasdaqGM:ACET) FY Conference Transcript
Adicet BioAdicet Bio(US:ACET)2025-09-08 21:32

Summary of Adicet Bio FY Conference Call Company Overview - Company: Adicet Bio (NasdaqGM:ACET) - Industry: Biotechnology, specifically focused on CAR T cell therapies for autoimmune diseases and cancer [2][3] Core Points and Arguments - Leadership in CAR T Therapies: Adicet Bio is recognized as a leader in developing off-the-shelf gamma delta one CAR T cell therapies for autoimmune diseases and cancer [2] - Clinical Validation: The platform has been clinically validated, showing high complete response (CR) rates and overall response rates in oncology studies, particularly in non-Hodgkin lymphoma (NHL) [3] - Safety Profile: Gamma delta one CAR T cells exhibit a more favorable safety profile compared to traditional alpha beta T cell therapies, with reduced incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [4] - Lead Program: The lead program, ADI-001, is in phase one for six autoimmune indications, with clinical data expected in the second half of the year [5][6] - Pipeline Expansion: The company is also targeting solid tumors, specifically prostate cancer, with enhanced potency through gene editing and armoring technologies [5][6] Clinical Study Insights - Key Learnings from Clinical Studies: The studies have shown robust exposure comparable to autologous CAR T therapies, with complete depletion of CD19 positive B cells in both blood and lymph nodes [8][9] - Importance of Lymph Node Depletion: Effective depletion of B cells in lymph nodes is crucial for demonstrating clinical activity in autoimmune diseases [12][13] - Unmet Medical Need: There is a significant unmet medical need in autoimmune diseases, with patients often relying on immunosuppressants and experiencing severe side effects [14][15] Target Product Profile - Efficacy and Safety Goals: The target product profile for ADI-001 aims for efficacy similar to autologous CD19 CAR T therapies, with a better safety profile to allow outpatient administration [16][17] - Regulatory Expectations: For lupus nephritis, a complete response (CR) rate of 40% or above is expected to meet regulatory thresholds for pivotal studies [23][32] Future Milestones - Upcoming Data Releases: Significant updates on the programs for lupus nephritis and systemic lupus erythematosus (SLE) are anticipated in the near future, with additional updates for systemic sclerosis and other indications expected [34][35] - Oncology Program: The company is also excited about its oncology program targeting prostate cancer, with plans to file an IND and start clinical development early next year [35] Additional Considerations - Challenges in Solid Tumors: The company acknowledges challenges in penetrating solid tumors, referred to as "cold tumors," and is working on enhancing the activity of gamma delta one T cells in these environments [37][38] - Comparative Data: The presentation referenced data from other companies, highlighting the competitive landscape and the need for objective endpoints in clinical studies [26][29][30] This summary encapsulates the key points discussed during the Adicet Bio FY Conference Call, focusing on the company's innovative approaches, clinical insights, and future directions in the biotechnology sector.