Drug intelligence / Profile preview

CD123-FLT3 HLE dBiTE

Development stage
Preclinical
Lead developer
Amgen
Modality
T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

CD123-FLT3 HLE dBiTE is a half-life extended (HLE) dual-targeting bispecific T-cell engager (dBiTE) developed by Amgen for the treatment of acute myeloid leukemia (AML). The molecule is designed to simultaneously target two tumor-associated antigens, CD123 (interleukin-3 receptor alpha) and FLT3 (FMS-like tyrosine kinase 3), while engaging CD3 on T cells to induce redirected lysis of leukemic cells. This dual-targeting approach aims to reduce the frequency of relapse caused by the loss of a single antigen. Preclinical evaluations in vitro and in mouse xenograft models demonstrated potent cytotoxicity against both single-positive and double-positive target cells. However, studies in non-human primates revealed tolerability challenges, including cytokine release and potential off-target effects on endothelial cells, where CD123 expression can be upregulated under inflammatory conditions.

Other names
CD123-FLT3 dBiTECD-123-FLT3 dBiTECD 123-FLT3 dBiTEdual CD123-FLT3 BiTE molecule
02

Targets

IL3RA (Interleukin 3 Receptor)CD3 (T-cell surface glycoprotein CD3)FLT3 (Fms related receptor tyrosine kinase 3)

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