NEW TAIPEI CITY, Taiwan — June 22, 2026 — GlycoNex, Inc. (TWO:4168) today announced that the multinational Phase 1 clinical trial of GNX1021, its first-in-class glycan-directed antibody-drug conjugate (ADC), has advanced into the execution phase in Taiwan and Japan. In Taiwan, the company has received clinical trial approval from the Taiwan Food and Drug Administration (TFDA), with patient enrollment expected to open in the third quarter of 2026. In Japan, the program received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) in April 2026 and Institutional Review Board (IRB) approval in May 2026, and the two regions will advance the trial in parallel.
The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of GNX1021 in patients with advanced gastrointestinal cancers, and to establish a recommended dose range for subsequent development. Both Taiwan and Japan are high-incidence regions for gastric cancer with extensive clinical experience and patient resources; conducting the study in parallel is intended to accelerate the generation of clinical data in Asian patients and to lay a foundation for subsequent global development, regulatory filings, and international partnering.
GNX1021 is a first-in-class glycan-directed ADC targeting branched Lewis B/Y (bLeB/Y). Unlike most ADCs, which recognize a single protein target, GNX1021 recognizes a carbohydrate antigen present across multiple tumor-associated proteins — offering the potential to address tumor heterogeneity and provide a new precision option for gastric cancer patients who lack suitable targeted therapies.