Drug intelligence / Profile preview

dr-0201

Development stage
Phase 1
Lead developer
Sanofi
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration
Intravenous
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Overview

DR-0201 is a first-in-class bispecific antibody developed by Dren Bio for the treatment of hematologic malignancies and autoimmune diseases. The drug binds on one arm to a phagocytic receptor on myeloid cells and on the other arm to a surface receptor highly expressed on B cells, such as CD20. This dual engagement enables DR-0201 to recruit and activate myeloid cells for targeted depletion of B cells through phagocytosis, resulting in deep B cell depletion. The primary indications under investigation include relapsed or refractory B-cell non-Hodgkin lymphomas (such as diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma) and several autoimmune disorders (including systemic lupus erythematosus, cutaneous lupus erythematosus, systemic sclerosis/scleroderma, polymyositis/dermatomyositis, and primary Sjogren's syndrome). DR-0201 is administered intravenously and is currently in Phase I clinical trials[1][2][3][4][5][7][8]. Sanofi acquired Dren Bio in March 2025 to bolster its immunology pipeline with DR-0201[4]. The drug has shown robust preclinical activity for deep B-cell depletion via targeted myeloid engagement.

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