The US Food and Drug Administration (FDA) has granted orphan drug designation to bexmarilimab for the treatment of acute myeloid leukemia (AML).

Bexmarilimab is a first-in-class, humanized monoclonal antibody designed to target Clever-1, a receptor on macrophages that leads to tumor growth and metastasis.

Bexmarilimab reprograms macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production, priming the immune system to attack tumors, and sensitizing cancer cells to standard care, according to Faron Pharmaceuticals, the company developing bexmarilimab.

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The company is currently evaluating bexmarilimab in combination with standard care in patients with AML and myelodysplastic syndromes in the phase 1/2 BEXMAB study ( Identifier: NCT05428969).


Faron receives FDA Orphan Drug designation for bexmarilimab in acute myeloid leukemia. News release. Faron. Accessed August 29, 2023.

This article originally appeared on MPR