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Major Win – FDA Grants Fast Track Designation to Adicet Bio’s ADI-001 for Lupus Disease
Adicet Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001. The treatment aims to help adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. Adicet is a clinical-stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Fast Track Designation helps accelerate the development and review of therapies targeting serious conditions with limited treatment options.
ADI-001 Clinical Trials Expand to Six Autoimmune Diseases, With Safety and Efficacy Assessments Underway
Adicet is in the process of evaluating the investigational therapy ADI-001 across six autoimmune indications. Along with SLE, patient enrollment is underway for a Phase I trial targeting lupus nephritis (LN), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS). The company expects to launch the trial in the first quarter of 2025 and plans to begin enrolling patients for a separate ADI-001 trial in anti-neutrophil cytoplasmic autoantibody (ANCA) -associated vasculitis in the second half of the year.
The trial’s primary endpoints will focus on evaluating the safety and tolerability of ADI-001, while secondary endpoints include assessing cellular kinetics, pharmacodynamics, autoantibody titer changes, and disease activity scores specific to each condition. Investigators will administer a single dose of ADI-001 to each group. A 28-day dose-limiting toxicity window will be observed before assessing response and safety. Follow-up evaluations will take place at months three, six, nine, 12, 18, and 24.
“The FDA’s decision to grant ADI-001 Fast Track Designation for lupus nephritis underscores the urgent need for new therapies for this chronic disease,” said Chen Schor, president and chief executive officer of Adicet Bio. “We plan to initiate our Phase 1 clinical study in lupus nephritis later this month.”
Targeted Gamma Delta T Cell Approach Offered by ADI-001 to Treat Lupus at Its Source
Lupus is an autoimmune disease that causes inflammation throughout the body, with symptoms varying based on the affected tissues. It can impact the skin, blood, joints, kidneys, brain, heart, and lungs. According to the Cleveland Clinic, SLE is the most common form, affecting multiple organ systems. Lupus symptoms typically develop gradually and may include joint, muscle, or chest pain, headaches, and much more. Additionally, patients often experience flare-ups, which can be severe enough to interfere with daily activities.
Current lupus treatments focus on managing symptoms, minimizing organ damage, and reducing the impact on daily life. Hydroxychloroquine, a disease-modifying antirheumatic drug, can help relieve symptoms and slow disease progression. Over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) reduce pain and inflammation, while corticosteroids like prednisone may be prescribed to control inflammation. Additionally, immunosuppressants help suppress immune system activity, preventing tissue damage and further inflammation.
Unlike these traditional therapies, which primarily manage symptoms, Adicet Bio’s ADI-001 is an investigational allogeneic gamma delta T cell therapy designed to target the underlying immune dysfunction in lupus. By leveraging the unique properties of gamma delta T cells, ADI-001 aims to provide a more precise and potentially long-lasting treatment approach rather than just suppressing immune activity.
Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio stated, “ADI-001 has the potential to be a transformative off-the-shelf treatment option for several autoimmune diseases. We look forward to initiating enrollment for SLE, SSc, IIM, and SPS patients in the first quarter of 2025 and for AAV patients in the second half of 2025.”
2024 Marked Significant Progress in Clinical Developments Said Adicet’s CEO
Adicet Bio made significant strides in 2024, advancing its research in autoimmune diseases and solid tumors. The company began dosing patients in clinical trials for its gamma delta 1 chimeric antigen receptor (CAR) T cell therapies, including ADI-001 for lupus nephritis (LN) and ADI-270 for clear cell renal cell carcinoma (ccRCC). Notably, ADI-270 became the first gamma delta CAR T cell therapy to enter clinical development for solid tumors.
Chen Schor, President and Chief Executive Officer at Adicet Bio said, “2024 was a momentous year for Adicet as we amplified our efforts in autoimmune diseases and solid tumors. We dosed our first patients in our clinical trials evaluating our gamma delta 1 chimeric antigen receptor (CAR) T cell candidates, ADI-001 in LN and ADI-270 in ccRCC. In the first half of 2025, we look forward to reporting preliminary data for both programs.”
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