Drug intelligence / Profile preview

CD16xCD33 BiKE

Development stage
Unknown
Lead developer
University of Minnesota
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

CD16xCD33 BiKE is a fully humanized bispecific antibody construct known as a "bispecific killer cell engager." It binds simultaneously to **CD16** (FcγRIIIa) on natural killer (NK) cells and **CD33** on target cells, primarily malignant myeloid cells. This dual-targeting enables the activation and redirection of NK cells to kill CD33-positive cells by engaging NK cell-mediated cytotoxicity, including degranulation and cytokine production (such as TNF-α and IFN-γ). The drug is being studied as a targeted immunotherapy for **acute myeloid leukemia (AML)**, **biphenotypic acute lymphoblastic leukemia (ALL)** that expresses CD33, and **myelodysplastic syndrome (MDS)**. Preclinical studies and early-phase trials have shown that CD16xCD33 BiKE enhances NK cell effector functions and promotes lysis of CD33^+^ leukemic cells and myeloid-derived suppressor cells. Potential uses include maintenance therapy or as a bridge to hematopoietic stem cell transplantation in pediatric and adult patients[1][2][3].

Other names
bispecific killer cell engager CD16xCD33
02

Targets

CD33 (Myeloid cell surface antigen CD33)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)

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