Drug intelligence / Profile preview

ATG-022

Development stage
Phase 3
Lead developer
Antengene
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

ATG-022 is an antibody-drug conjugate (ADC) targeting the tumor-associated antigen Claudin 18.2 (CLDN18.2), which is overexpressed in several solid tumors, particularly gastric, esophageal, and pancreatic cancers. The drug consists of a humanized monoclonal antibody that binds to CLDN 18.2 with high sub-nanomolar affinity and is conjugated via a cleavable linker to the cytotoxic payload monomethyl auristatin E (MMAE). This design enables selective delivery of the cytotoxin to cancer cells expressing CLDN 18.2, inducing apoptosis while sparing normal tissues due to limited expression of this antigen outside tumors. Preclinical studies have demonstrated potent antitumor activity both in vitro and in vivo across models with varying levels of CLDN 18.2 expression, including low-expression settings[1][5][6][7]. ATG-022 has shown manageable safety and encouraging preliminary efficacy in early-phase clinical trials for advanced or metastatic solid tumors[1][3]. The drug has received orphan drug designation from the FDA for gastric cancer and pancreatic cancer[2][4].

Other names
CLDN18.2 antibody-drug conjugateCLDN-18.2 antibody-drug conjugateCLDN 18.2 antibody-drug conjugate
02

Targets

Claudin 18.2

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