GlycoNex has received Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approval to commence a first-in-human Phase I clinical trial of GNX1021, its lead antibody-drug conjugate (ADC) candidate, for advanced gastrointestinal cancers.
The approval enables GlycoNex to begin clinical-stage development for its proprietary glycan-targeting ADC platform.
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The planned multi-centre, multinational trial will evaluate the pharmacokinetics, tolerability, safety, and initial efficacy of GNX1021, and aims to define a recommended dose for future trials. Initial patient recruitment will take place in Japan and Taiwan.
GlycoNex plans to begin enrolling patients in Japan by June 2026. It also expects to submit an investigational new drug (IND) application in Taiwan during the same month, with enrolment anticipated later in the third quarter.
GNX1021 targets branched glycan antigens that are abnormally present on tumour cells, compared to traditional therapies that recognise a single protein epitope.
The antibody leverages aberrant glycan expression among various tumour-associated membrane proteins, thereby enabling multi-target engagement and addressing a limitation of established targeted oncology agents.
Targeted by GNX1021, the bLeB/Y antigen is highly expressed in epithelial tumours such as colorectal, gastric, and pancreatic cancers, but demonstrates minimal presence in healthy human tissue.
This specificity is intended to enhance patient safety and the therapeutic index during treatment.
GlycoNex CEO Dr Mei-Chun Yang said: “PMDA approval to initiate our first-in-human study is a defining milestone for GlycoNex and a critical validation of our glycan-targeting platform.
“GNX1021 represents a differentiated approach to ADC development, designed to address tumour heterogeneity by targeting glycan structures broadly expressed across multiple cancer-associated proteins.
“We believe this unique mechanism, combined with the selective expression of the bLeB/Y antigen in gastrointestinal tumours, positions GNX1021 to potentially deliver meaningful clinical benefit, particularly in gastric cancer, where new treatment options are urgently needed.”
