Adicet Bio Inc.
09/01/2026 | Press release | Distributed by Public on 09/01/2026 05:02
Unveiling next-generation in vivo CAR-T platform and pipeline targeting hematological malignancies and solid tumors; first candidate expected to enter clinical development in[...]
Unveiling next-generation in vivo CAR-T platform and pipeline targeting hematological malignancies and solid tumors; first candidate expected to enter clinical development in 2H 2027
REDWOOD CITY, Calif. - September 1, 2026 - Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and in vivo CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today 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.
The Company plans to host an investor webcast upon release of the topline data to discuss the results and next steps for the program.
"We are pleased with the level of interest from investigators and patients in our study evaluating prula-cel in patients with SLE with or without LN and look forward to the planned readout later this month," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "As we advance this program, we are also executing across our broader pipeline, including initiating start up activities for our Phase 1 study of ADI-212 in mCRPC, following the recent IND clearance by the FDA, while continuing to progress our differentiated in vivo CAR-T platform, with our first candidate expected to enter clinical development in the second half of 2027."
Prula-cel Autoimmune Program on Track for 3Q 2026 Data Readout
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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.
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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.
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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.
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Clinical update in patients with systemic sclerosis expected in the fourth quarter of 2026.
ADI-212 IND Cleared by FDA; Program Advancing into Clinic
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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.
Advancing the Company's Diversified In Vivo CAR-T Portfolio Towards Clinical Development
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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.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical-stage biotechnology company discovering and developing a broad pipeline of allogeneic gamma delta T cell therapies, engineered with chimeric antigen receptors (CARs), alongside differentiated in vivo CAR-T therapies with the potential to redefine treatment across autoimmune diseases, hematologic malignancies and solid tumors. For more information, please visit our website at https://www.adicetbio.com.
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