Drug intelligence / Profile preview

AMG 305

Development stage
Phase 1
Lead developer
Amgen
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

AMG 305 is a bispecific T-cell engager (BiTE) monoclonal antibody developed by Amgen for the treatment of advanced solid tumors. It specifically targets tumor cells that co-express cadherin-3 (CDH3) and mesothelin (MSLN), while also binding to CD3 on cytotoxic T lymphocytes. This dual targeting enables the recruitment and activation of T cells to induce potent cytotoxicity against tumor cells expressing both CDH3 and MSLN antigens. Preclinical studies have shown dose-dependent antitumor activity in xenograft models, with good tolerability in non-human primates at exposure levels above predicted human efficacious doses. The drug is currently being evaluated in Phase 1 clinical trials for safety, tolerability, pharmacokinetics, and preliminary efficacy in adults with advanced solid tumors[1][2][3][4][5][6].

Other names
anti-CDH3/MSLN BiTE antibody
02

Targets

CDH3 (Cadherin-3)MesothelinCD3 (T-cell surface glycoprotein CD3)

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