GNX1021 Cleared by Japan's PMDA to Begin First-in-Human Phase 1 Trial
Japan's regulator authorizes first-in-human dosing for GlycoNex's lead glycan-targeted antibody-drug conjugate in patients with advanced gastrointestinal cancers.
NEW TAIPEI CITY, Taiwan — April 14, 2026 — GlycoNex, Inc. (TWO:4168) today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has cleared GNX1021, the company's lead glycan-targeted antibody-drug conjugate (ADC), to begin a first-in-human Phase 1 clinical trial in patients with advanced gastrointestinal cancers.
GNX1021 targets branched Lewis B/Y (bLeB/Y), a tumor-associated carbohydrate antigen overexpressed on epithelial tumors including gastric, colorectal, and pancreatic cancers but minimally expressed on healthy human tissue. Preclinical studies have demonstrated antitumor activity in both HER2-low and high-tumor-burden models, suggesting potential utility in patient populations not adequately addressed by existing HER2- or CLDN18-targeted therapies.
Patient enrollment in Japan is expected to begin in the second quarter of 2026, with a parallel Investigational New Drug (IND) submission planned in Taiwan in the same quarter.
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 tumor 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 tumors, positions GNX1021 to potentially deliver meaningful clinical benefit, particularly in gastric cancer, where new treatment options are urgently needed.
— Dr. Mei-Chun Yang, President and CEO, GlycoNex, Inc.
GNX1021 is the lead asset in GlycoNex's glycan-directed ADC pipeline, developed from the company's GlycoSH antibody collection. Further detail on the program is available on the GNX1021 pipeline page.
Contact
Media: GlycoNex, Inc. — mail@glyconex.com.tw (please indicate "Media Inquiry" in the subject line).
