Drug intelligence / Profile preview

bexmarilimab + azacitidine

Development stage
Unknown
Lead developer
Faron Pharmaceuticals
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Subcutaneous
01

Overview

Bexmarilimab + azacitidine is a combination regimen under clinical investigation for high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). **Bexmarilimab** is a humanized IgG4 monoclonal antibody targeting the Clever-1 receptor on macrophages and myeloid blasts, reprogramming the tumor microenvironment by converting immunosuppressive (M2) macrophages to an immunostimulatory (M1) phenotype, enhancing antigen presentation and T-cell activation, and impairing energy production in blasts. When combined with **azacitidine**, a hypomethylating agent, the regimen works synergistically to augment cytotoxic efficacy against malignant myeloid cells, particularly in patients who have failed standard therapies. The combination has shown promising safety and efficacy data in Phase 1/2 studies, with high objective response rates and manageable toxicity. Development is led by Faron Pharmaceuticals, with ongoing registrational Phase 2/3 studies targeting treatment-naïve and relapsed/refractory HR-MDS and AML[1][2][3][4][5].

Other names
bexmarilimab + SoC
02

Targets

STAB1 (Common lymphatic endothelial and vascular endothelial receptor 1)DNMT (DNA methyltransferase)

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