Drug intelligence / Profile preview

FAP-directed BiTE molecule

Development stage
Preclinical
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, Subcutaneous
01

Overview

FAP-directed BiTE molecule is a target-specific bispecific T-cell engager (BiTE) platform designed to simultaneously bind fibroblast activation protein (FAP) on target cells and CD3 on T cells. This dual binding redirects T-cell-mediated cytotoxicity to selectively deplete FAP-expressing cells, such as activated fibroblasts or modulated vascular smooth muscle cells. Developed in collaboration between Amgen and Washington University School of Medicine, FAP-directed BiTE molecules are being investigated in preclinical models for the treatment of cardiac fibrosis, atherosclerosis, and coronary artery disease. While effective at depleting FAP-positive cells, preclinical studies in cardiac injury models have revealed potential liabilities, such as accelerated cardiac deterioration driven by collateral interferon-gamma and CD40L signaling, which can be mitigated by co-blocking these pathways.

Other names
FAP BiTEFAP-directed BiTEanti-FAP BiTEanti-FAP bispecific T-cell engageranti-FAP HLE BiTE
02

Targets

FAP (Fibroblast activation protein alpha)CD3 (T-cell surface glycoprotein CD3)

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