Drug intelligence / Profile preview

GNX1021

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

Overview

GNX1021 is a first-in-class antibody-drug conjugate (ADC) designed to target branched Lewis B/Y (bLeB/Y), a tumor-associated glycan highly expressed in gastric cancer and other epithelial tumors[3][2][1]. GNX1021 is engineered to selectively bind this glycan, which is distinct from targets of existing HER2- or CLDN18-based therapies, and is conjugated to the cytotoxic payload Monomethyl auristatin E (MMAE) via an enzyme-cleavable linker, enabling cell-specific delivery of the anticancer agent[9]. Preclinical studies have shown potent antitumor activity, including in HER2-ADC resistant models, and a favorable safety profile comparable to approved ADCs[2][6][4]. GNX1021 is being developed by GlycoNex as a potential precision therapy for patients with gastric cancer and potentially other solid tumors, especially those ineligible for current targeted treatments[1][3]. As of October 2025, GNX1021 is in IND-enabling preclinical development, with first-in-human Phase 1 clinical trials planned for 2026[3][2][1][7].

Other names
GNX1021GNX-1021GNX 1021
02

Targets

Le^b (Lewis b antigen)

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