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AMV-564

Alternative Names: amv-564, amv564, amv 564
Latest Update: 2024-05-02
Latest Update Note: PubMed Publication

Product Description

AMV564 is a novel bivalent, bispecific (2:2) CD33/CD3 T-cell engager that binds CD33 on target cells and CD3 on T-cells leading to T-cell-directed lysis of CD33+ leukemic blasts and myeloid derived suppressor cells (MDSCs), as well as T-cell expansion, differentiation and proliferation. By design, AMV564 has reduced clearance and therefore has a longer half-life (t1/2) than monovalent, bispecific T-cell engagers. In preclinical investigations using both leukemic cell lines and primary cells from AML patients, AMV564 eliminated myeloid blasts with picomolar potency and broad activity independent of cytogenetic or molecular abnormalities, CD33 expression level, and disease stage, with no nonspecific activation of T cells. (Sourced from: https://ashpublications.org/blood/article/134/Supplement_1/834/427055/Phase-1-First-in-Human-Trial-of-AMV564-a-Bivalent)

Mechanisms of Action: CD33 Binder,CD3 Binder

Novel Mechanism: Yes

Modality: Bispecific Antibody

Route of Administration: Intravenous,Subcutaneous

FDA Designation: None *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Amphivena
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for AMV-564

Countries in Clinic:

Active Clinical Trial Count:

Highest Development Phases

Phase 1: Acute Myeloid Leukemia|Preleukemia|Myelodysplastic Syndrome|Oncology Solid Tumor Unspecified

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

AMV564-301

P1

Unknown status

Oncology Solid Tumor Unspecified

2021-12-15

30%

AMV564-201

P1

Completed

Preleukemia|Myelodysplastic Syndrome

2020-07-31

21%

AMV564-101

P1

Completed

Acute Myeloid Leukemia

2020-07-21

30%

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