Drug intelligence / Profile preview

LUA005

Development stage
Preclinical
Lead developer
Qilu Pharmaceutical
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

LUA005 is a differentiated bivalent EGFR/cMET bispecific antibody-drug conjugate (ADC) developed by Qilu Pharmaceutical. It is engineered with bivalent arms for both EGFR and cMET, employing a low-affinity but high-avidity binding strategy for EGFR and high-affinity binding for cMET. This design is intended to minimize on-target off-tumor toxicity in normal tissues, such as skin keratinocytes, while ensuring robust efficacy across heterogeneous tumors. LUA005 is built on Qilu's proprietary topoisomerase-1 inhibitor platform, featuring a hydrophilic cleavable linker and a uniform drug-to-antibody ratio (DAR) of 8. The payload is a novel topoisomerase-1 inhibitor that exhibits nanomolar activity and faster systemic clearance than Dxd, potentially improving the therapeutic window. Preclinical studies have shown superior antitumor activity in various models, including those resistant to osimertinib and cetuximab, with clinical trials expected to commence in early 2026.

02

Targets

MET (Mesenchymal-epithelial transition factor receptor)EGFR T790M (Epidermal growth factor receptor T790M mutant)FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)FCGRT (Neonatal crystallizable fragment receptor)

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