AMV564

**AMV564** is a novel bivalent, bispecific (2:2) T-cell engager that simultaneously binds CD33 on myeloid cells and the invariant CD3ε on T-cells with high avidity, forming an immune synapse that redirects T-cells to lyse CD33-expressing targets. Developed by Amphivena Therapeutics (later acquired by Affimed), it demonstrates potent cytotoxic activity against CD33-positive cells, including leukemic blasts, immunosuppressive myeloid-derived suppressor cells (MDSCs), and shows preclinical efficacy in AML xenografts, MDS explants, and melanoma models by depleting MDSCs, enhancing T-cell activation/proliferation, and improving hematopoiesis. It has received FDA Orphan Drug Designation for AML and is under investigation in phase 1 trials for relapsed/refractory AML, high-risk MDS, and advanced solid tumors, with preliminary data indicating safety, tolerability, and activity.[1][2][3][4][5][6][7][9][10][12]

Other names

Vixtimotamab