IMGN632 + azacitidine

IMGN632 + azacitidine is an investigational combination therapy that includes IMGN632, a CD123-targeting antibody-drug conjugate (ADC), with azacitidine, a hypomethylating agent. IMGN632 (also known as pivekimab sunirine) consists of a high-affinity humanized IgG1 antibody targeting CD123, conjugated via a cleavable linker to a DNA-alkylating payload of the indolinobenzodiazepine pseudodimer (IGN) class. The IGN payload induces DNA single-strand breaks, promoting apoptosis in malignant cells. Azacitidine inhibits DNA methylation, reactivating silenced genes and inducing cytotoxicity in abnormal hematopoietic cells. The combination is being evaluated primarily for CD123-positive acute myeloid leukemia (AML), particularly in settings where resistance or suboptimal response to standard azacitidine-based regimens is a concern. Preclinical and early clinical studies show synergistic antileukemic activity, enhancing cell death and overcoming resistance observed with azacitidine/venetoclax in AML models. This combination is under investigation in Phase 1b/2 clinical trials for patients with relapsed/refractory and frontline AML[1][2][3][4][5][7].

Other names

pivekimab sunirineazacitidine