Overview
CD70 is a ligand expressed on the surface of activated lymphocytes and mature dendritic cells that, in its binding to CD27 receptors, plays an important role in cell proliferation and survival. An overexpression of CD70 can result in the proliferation of malignant cells and has been documented in a variety of solid and hematological malignancies. Cusatuzumab is a humanized IgG1 antibody targeted against CD70. It is currently being investigated in the Phase 2 CULMINATE trial, in combination with azacitidine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) in patients unsuitable for chemotherapy.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Report on Cusatuzumab (ARGX-110): A Comprehensive Analysis of a CD70-Targeting Monoclonal Antibody
I. Executive Summary
Cusatuzumab is an investigational, first-in-class, glyco-engineered humanized IgG1 monoclonal antibody targeting the CD70 antigen, a member of the tumor necrosis factor (TNF) superfamily. Developed initially by argenx, cusatuzumab is being evaluated primarily for the treatment of Acute Myeloid Leukemia (AML), a hematological malignancy characterized by poor outcomes, particularly in elderly patients unfit for intensive chemotherapy. The therapeutic rationale for targeting CD70 is compelling; while its expression is transient and restricted in normal tissues, it is aberrantly overexpressed in a multitude of cancers, including over 95% of AML blasts. In AML, the interaction of CD70 with its receptor, CD27, promotes a cell-autonomous signaling cascade that is critical for the proliferation and survival of Leukemia Stem Cells (LSCs)—the chemotherapy-resistant cell population responsible for disease initiation and relapse.
The mechanism of action of cusatuzumab is dual-pronged, combining direct antagonism with potent immune-mediated killing. By binding to CD70, it blocks the pro-survival CD70/CD27 signaling pathway. Concurrently, its Fc region, which has been defucosylated via Potelligent® technology, exhibits dramatically enhanced binding to Fcγ receptors on immune effector cells, leading to powerful Antibody-Dependent Cellular Cytotoxicity (ADCC), Complement-Dependent Cytotoxicity (CDC), and Antibody-Dependent Cellular Phagocytosis (ADCP). This dual mechanism is designed to eliminate both bulk tumor cells and the underlying LSC reservoir.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/25 | Phase 2 | Recruiting | |||
2020/02/11 | Phase 2 | Withdrawn | |||
2020/01/27 | Phase 1 | Completed | |||
2019/11/05 | Phase 1 | Active, not recruiting | |||
2019/07/17 | Phase 2 | Active, not recruiting | |||
2017/01/25 | Phase 1 | Completed | |||
2016/05/03 | Phase 1 | Completed | |||
2013/03/19 | Phase 1 | Completed |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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