Drug intelligence / Profile preview

SIM0610

Development stage
Phase 1
Lead developer
Simcere Zaiming
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

SIM0610 is a bispecific antibody-drug conjugate (BsADC) developed by Jiangsu Simcere Pharmaceutical Co., Ltd. (through its subsidiary Simcere Zaiming) for the treatment of advanced solid tumors. It simultaneously targets two key oncogenic drivers: the epidermal growth factor receptor (EGFR) and the mesenchymal-epithelial transition factor (cMET). The drug consists of a humanized anti-EGFR/cMET bispecific antibody conjugated to a topoisomerase I inhibitor (TOP1i) payload via a cleavable hydrophilic linker. SIM0610 is designed to overcome resistance to EGFR-targeted therapies and exhibits potent anti-proliferative activity, including a bystander effect that allows it to suppress tumor growth even in cells with low target expression. It is currently being evaluated in a first-in-human Phase 1 clinical trial for patients with locally advanced or metastatic solid tumors, including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and hepatocellular carcinoma.

02

Targets

TOP1 (DNA Topoisomerase I)EGFR T790M (Epidermal growth factor receptor T790M mutant)MET (Mesenchymal-epithelial transition factor receptor)

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