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.