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Research Report
AMX-525 (VIR-5525): A Comprehensive Report on a Novel Masked EGFRxCD3 T-Cell Engager
2. Introduction to AMX-525: A Novel Masked T-Cell Engager
AMX-525, also identified by its developmental code SAR446368 and current clinical identifier VIR-5525, is an investigational biopharmaceutical agent engineered as a next-generation T-cell engager (TCE).[1] It is currently in the early stages of clinical development for the treatment of various solid malignancies. The core therapeutic challenge AMX-525 aims to surmount is the significant dose-limiting systemic toxicities frequently associated with conventional TCE bispecific antibodies. These toxicities, often stemming from on-target, off-tumor engagement of T-cells, can severely curtail therapeutic efficacy and restrict the broader clinical applicability of TCEs.
AMX-525 represents an advancement in this field, employing a sophisticated protease-activated masking technology, known as XPAT™ (XTENylated Protease-Activated bispecific T-Cell Engagers) or Pro-XTEN™. This platform is designed to ensure that the potent T-cell-mediated cytotoxicity is predominantly unleashed within the tumor microenvironment (TME), thereby enhancing tumor-specific killing while minimizing systemic adverse events.[3] The fundamental strategy is to improve the therapeutic index by localizing potent immune activation specifically to the tumor site.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/07 | Phase 1 | Recruiting |
FDA Drug Approvals
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EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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