Adicet Bio

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Adicet Bio's phase 1 trial (NCT06375993) has dosed its first lupus nephritis (LN) patient with ADI-100, an allogeneic CAR-engineered gamma delta T-cell therapy for autoimmune diseases. The trial will expand to include systemic lupus erythematosus (SLE), systemic sclerosis (SSc), antineutrophil cytoplasmic autoantibody associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS), with enrollment for SLE, SSc, IIM, and SPS starting in H1 2025 and AAV in H2 2025. Initial LN data is expected in H1 2025. At the 2024 ACR Convergence, Adicet presented biomarker data from the GLEAN trial (NCT04735471) suggesting ADI-001's potential for treating autoimmune diseases, showing robust CAR T-cell activation and complete CD19+ B-cell depletion.

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Adicet Bio, Inc. announces first LN patient dosed in Phase 1 trial of ADI-001 for autoimmune diseases, with preliminary data expected in 1H25. Enrollment for SLE, SSc, IIM, and SPS planned for 1Q25, and AAV for 2H25.

Adicet Bio has dosed the first lupus nephritis patient in the Phase 1 trial of ADI-001 for autoimmune diseases, with preliminary data expected in 1H25. Additional enrollments for systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, and stiff person syndrome are planned for 1Q25, and ANCA-associated vasculitis for 2H25. The FDA has granted Fast Track Designation to ADI-001 for relapsed/refractory class III or IV lupus nephritis and cleared the IND amendment for stiff person syndrome and idiopathic inflammatory myopathy treatment.

Adicet Bio presented clinical biomarker data for ADI-001, their off-the-shelf gamma delta CAR T cell therapy, at ACR Convergence 2024, showing robust tissue homing and complete CD19+ B cell depletion in secondary lymphoid tissue, with CAR T cell activation levels of 27-64% at the 1E9 dose. The company is advancing ADI-001 in a basket study across six autoimmune indications.

Adicet Bio reports Q3 2024 net loss of $30.5 million, expands ADI-001 Phase 1 trial to six autoimmune indications, expects lupus nephritis data in 1H25, maintains $202.1 million in cash, and receives FDA Fast Track Designation for ADI-270 in advanced renal cell carcinoma.

In October 2024, the FDA cleared IND applications for an allogeneic CAR-engineered gamma delta T-cell therapy for IIM and SPS, the first IND clearance for a circular RNA therapy, and held meetings with companies planning BLA submissions for advanced therapeutics. Nanoscope plans to file a BLA for RP gene therapy MCO-010 in Q1 2025. Adicet's ADI-100 received IND amendment clearance for IIM and SPS trials. Sangamo aligned with FDA on an accelerated approval pathway for Fabry disease gene therapy ST-920. RiboX's RXRG001, the first circular RNA therapy, was cleared for a phase 1/2a trial in RIX and hyposalivation.

Adicet Bio, Inc. announced its management will participate in three investor conferences in November: Truist Securities BioPharma Symposium (Nov 7, NY), Guggenheim Securities Healthcare Innovation Conference (Nov 12, Boston), and Jefferies London Healthcare Conference (Nov 19, London).

Adicet Bio's ADI-100, a CAR-engineered gamma delta T-cell therapy, received FDA clearance to recruit patients with idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) into its phase 1 clinical trial for lupus nephritis (LN). The trial now includes arms for LN and systemic lupus erythematosus (SLE), systemic sclerosis (SSc), antineutrophil cytoplasmic autoantibody associated vasculitis (AAV), and IIM and SPS, with treatment for the latter expected to start in Q1 2025.