TAIPEI, Aug. 3, 2026 /PRNewswire/ -- GlycoNex Inc. (TPEx: 4168) today announced that the first patient has been successfully dosed in the First-in-Human (FIH) Phase I clinical trial of GNX1021, the Company's novel glycan-targeting antibody-drug conjugate (ADC), in Japan. The milestone marks GNX1021's transition into clinical development and initiates the generation of the first human data for the Company's lead oncology asset.
The start of dosing represents an important value inflection point for GlycoNex. It advances GNX1021 from preclinical development into the clinic, reducing development uncertainty, increasing the maturity of the asset, and establishing the foundation for clinical safety, pharmacokinetic and early activity data that will define the program's future direction and strengthen its positioning for strategic collaboration.
GNX1021 is directed at the branched Lewis B/Y (bLeB/Y) glycan antigen, which is highly expressed in gastric cancer and other gastrointestinal malignancies while showing limited expression in normal tissue. Rather than targeting a single protein receptor - the approach taken by most ADCs currently in development - GNX1021 recognizes a tumor-associated glycan structure presented across multiple carrier molecules on the cancer-cell surface. This differentiated mechanism is designed to broaden the pool of addressable targets, enhance tumor selectivity, and address the therapeutic challenges posed by tumor heterogeneity, positioning GNX1021 distinctly within a competitive ADC landscape. GNX1021 is the lead program to emerge from GlycoNex's proprietary GlycoSH anti-glycan antibody library, which continues to generate a pipeline of glycan-directed ADCs and related candidates.
The FIH study is a multinational, multicenter Phase I trial being conducted in Japan and Taiwan in patients with advanced solid tumors, evaluating GNX1021 across multiple dose levels for safety and tolerability, pharmacokinetics, immunogenicity, preliminary anti-tumor activity, and the recommended dose for subsequent development. Data from the study are expected to inform dose selection and the future development strategy for GNX1021, including its potential evaluation in selected gastrointestinal cancer populations.
GlycoNex intends to explore potential regional and global licensing, co-development, and other strategic collaboration opportunities for GNX1021. The Company will continue to advance the program within its broader glycan-directed oncology pipeline and assess the development and partnership strategies most appropriate for its long-term clinical and commercial development.
"Dosing the first patient in the GNX1021 Phase I trial is a major achievement for GlycoNex and an important value inflection point for our oncology portfolio," said Dr. Mei-Chun Yang, President and CEO of GlycoNex. "GNX1021 is designed to address tumor-associated glycan structures that conventional protein-targeted therapies may not adequately capture. Advancing this differentiated program into the clinic allows us to evaluate its potential in patients while building a stronger foundation for future development and strategic collaboration."
About GlycoNex
GlycoNex Inc. (TPEx: 4168) is a Taiwan-based, clinical-stage biopharmaceutical company specializing in glycan-directed antibody therapeutics. Building on more than two decades of experience in glycobiology and antibody development, GlycoNex has established the proprietary GlycoSH anti-glycan antibody library and an integrated development organization spanning discovery, cell-line and process development, analytics, clinical manufacturing and clinical development. The Company is advancing a differentiated pipeline of glycan-targeted antibody-drug conjugates - led by GNX1021 - alongside biosimilar programs, supported by long-standing international development and manufacturing partnerships. For additional information, please visit www.glyconex.com.tw.
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