Adicet plans to file an investigational new drug (IND) for ADI-270 with the FDA in H1 2024. Image Credit: ART-ur / Shutterstock.

Adicet Bio plans to focus all its resources on advancing the chimeric antigen receptor (CAR)-T cell therapies, ADI-001, and ADI-270, after pausing the development of its preclinical programme for ADI-925.

CAR-T cell therapies have been identified as a key immuno-oncology innovation area by GlobalData. The CAR-T cell market is expected to be worth $25bn by 2028, as per GlobalData analysis.

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ADI-001 clinical trial update

ADI-001 is a CAR-T cell therapy that targets CD20. It is being evaluated as treatment for relapsed or refractory B-cell malignancies, including non-Hodgkin’s lymphoma (NHL), in a Phase I clinical trial (NCT04735471). The trial is currently recruiting patients with mantel cell lymphoma, a type of B-cell lymphoma, as per an 8 November press release.

Adicet has also initiated an expansion cohort (EXPAND) as part of the Phase I trial and plans to evaluate patients with larger B-cell lymphoma (LBCL) post-CAR-T cell therapy. The company also expanded its manufacturing capabilities to accommodate additional demand.

The company plans to provide a clinical update on the Phase I study in H2 2024. It plans to advance the drug under an accelerated approval pathway to Phase II trial in post-CAR-T LBCL and/or MCL patients.

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Preclinical pipeline update

Adicet plans on developing ADI-270 for treating renal cell carcinoma, with potential in other solid tumour indications. ADI-270 is a CD70 targeting CAR-T cell therapy.

The company received positive feedback from the US Food and Drug Administration (FDA) during the pre-IND meeting. It plans to file an investigational new drug (IND) for ADI-270 with the FDA in H1 2024.

Adicet had cash reserves of $183.3m as of 30 September 2023. These are expected to fund operations into H1 2025. The company has a market cap of $61.42m.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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