GlycoNex has received approval from Japan’s Pharmaceuticals and Medical Devices Agency to initiate a first-in-human (FIH) Phase I clinical trial of its lead antibody-drug conjugate (ADC) candidate, GNX1021, for the treatment of advanced gastrointestinal cancers.

The approval marks a significant milestone for the company, signalling its transition into clinical-stage development for its glycan-targeting ADC platform. The therapy is being developed to address unmet medical needs in cancers such as gastric, pancreatic and colorectal malignancies.

The multi-centre, multinational Phase I study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of GNX1021, while also determining an optimal dose range for further clinical development. The initial phase of the trial will be conducted in Japan and Taiwan, with patient enrolment in Japan expected to begin in June 2026 and regulatory submissions in Taiwan planned shortly thereafter.

GNX1021 represents a novel approach in oncology by targeting abnormal glycan structures expressed across multiple tumour-associated proteins, rather than focusing on a single protein target. This mechanism is designed to overcome tumour heterogeneity and improve treatment effectiveness. The drug specifically targets the bLeB/Y antigen, which is highly expressed in several epithelial cancers but shows minimal presence in healthy tissues, enabling greater precision and safety.

Preclinical studies have demonstrated a favourable safety profile, with stable metabolism and no significant toxicity observed in animal models. These findings support the progression of GNX1021 into human trials and highlight its potential as a next-generation cancer therapy.

The company believes that its differentiated platform could attract global interest as development progresses, particularly amid growing demand for innovative ADC therapies targeting difficult-to-treat cancers.