Announcement • Sep 03

Adicet Bio Announces Completion of Last Patient Visit for Planned Analysis of prula-cel (formerly ADI-001) Study in Patients with Systemic Lupus Erythematosus With or Without Lupus Nephritis and Provides Corporate Update

Adicet Bio, Inc. announced completion of the last patient visit for the planned Phase 1 safety and efficacy analysis of prulacabtagene leucel (prula-cel) in patients with systemic lupus erythematosus (SLE) with or without lupus nephritis (LN). The Company expects to report topline data in September 2026. Prula-cel topline data from SLE patients with or without LN expected in September 2026. The planned analysis includes data from 22 SLE patients with or without LN with a minimum of 6 months of follow-up, including 13 patients with at least 12 months of follow-up. Potential registrational trial design in development following FDA interaction. Additional information regarding potential pivotal trial design is expected as part of the upcoming prula-cel clinical update later this month. Expanded prula-cel administration into outpatient setting following FDA alignment, enabling LN and other SLE patients in current and future studies to receive treatment in the outpatient setting. Clinical update in patients with systemic sclerosis expected in the fourth quarter of 2026. FDA clearance of IND application for ADI-212, a next-generation, gene-edited, armored cell therapy candidate designed to address the complexity of solid tumors. In August 2026, the FDA cleared the Company’s Investigational New Drug Application (IND) for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate enrollment in the fourth quarter of 2026 in patients with mCRPC. Designed as an off-the-shelf product, ADI-212 incorporates multiple platform enhancements by incorporating gene-editing and expression of a novel immune-stimulating molecule intended to strengthen anti-tumor potency, including improved antigen engagement, capacity for durable tumor-killing and active modulation of the tumor microenvironment. Progressing a diversified portfolio of in vivo CAR-T programs designed to address significant unmet needs in both hematologic malignancies and solid tumors. The Company is advancing a differentiated in vivo CAR-T platform and pipeline to potentially optimize in vivo T cell transduction to yield highly cytolytic CAR-T therapy. Ongoing preclinical activities include programs targeting multiple myeloma, non-Hodgkin’s lymphoma, and solid tumor indications. Based on progress to date, the Company expects to advance the first candidate from its in vivo CAR-T portfolio into clinical development in the second half of 2027.

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Adicet Bio Announces Completion of Last Patient Visit for Planned Analysis of prula-cel (formerly ADI-001) Study in Patients with Systemic Lupus Erythematosus With or Without Lupus Nephritis and Provides Corporate Update

Adicet Bio Receives FDA Clearance Of IND Application For ADI-212 For Treatment Of Metastatic Castration-Resistant Prostate Cancer

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