Drug intelligence / Profile preview

AMG 512

Development stage
Discontinued
Lead developer
Amgen
Modality
T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

AMG 512 (also known as CDH19 BiTE) is a bispecific T-cell engager (BiTE) antibody construct developed by Amgen for the treatment of melanoma. It is designed to simultaneously bind to cadherin-19 (CDH19), an unconventional type 2 cadherin highly expressed in melanoma, and the CD3 epsilon subunit of the T-cell receptor complex. By bridging these two targets, AMG 512 redirects the cytotoxic activity of T cells to specifically eliminate CDH19-expressing melanoma cells. The molecule is a half-life extended (HLE) BiTE, incorporating an Fc domain to prolong its circulatory presence. Preclinical data indicated potent anti-tumor activity, including against cells resistant to BRAF/MEK inhibitors and checkpoint inhibitors. Clinical development was halted following a Phase 1 study.

Other names
CDH19 BiTECDH-19 BiTECDH 19 BiTEanti-CDH19/CD3 HLE BiTECDH19-CD3 BiTECDH-19-CD3 BiTECDH 19-CD3 BiTECDH19-CD3 bispecific T-cell engagerCDH-19-CD3 bispecific T-cell engagerCDH 19-CD3 bispecific T-cell engager
02

Targets

CD3 (T-cell surface glycoprotein CD3)CDH19 (Cadherin-19)FCGRT (Neonatal crystallizable fragment receptor)

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