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
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 1: Preleukemia|Acute Myeloid Leukemia|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 |
42% |
| AMV564-201 | P1 |
Completed |
Myelodysplastic Syndrome|Preleukemia |
2020-07-31 |
22% |
| AMV564-101 | P1 |
Completed |
Acute Myeloid Leukemia |
2020-07-21 |
42% |