Drug intelligence / Profile preview

AN4035 + cetuximab

Development stage
Phase 1
Lead developer
Adlai Nortye
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

AN4035 + cetuximab is an investigational combination therapy being evaluated for the treatment of advanced or metastatic solid tumors harboring RAS mutations and expressing CEACAM5. AN4035 is a novel antibody-drug conjugate (ADC) developed by Adlai Nortye, featuring a monoclonal antibody targeting Carcinoembryonic Antigen-Related Cell Adhesion Molecule 5 (CEACAM5) conjugated to a proprietary pan-RAS(ON) inhibitor payload via a hydrophilic, enzyme-cleavable linker. Cetuximab is a chimeric monoclonal antibody that inhibits the Epidermal Growth Factor Receptor (EGFR). The combination strategy leverages the mechanistic complementarity of inhibiting EGFR upstream and RAS downstream, aiming to enhance pathway suppression and overcome therapeutic resistance in RAS-mutated cancers while minimizing systemic toxicity through targeted delivery.

Other names
AN4035 + EGFR inhibitor
02

Targets

CEACAM5 (Carcinoembryonic antigen related cell adhesion molecule 5)EGFR (Epidermal growth factor receptor)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)HRAS (H-Ras protein)

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