#Japan #gastric cancer #GlycoNex #Hokkaido #Hokkaido University

GlycoNex Partners with Hokkaido University for Gastric Cancer Study

GlycoNex, Inc. (stock code: 4168), a biotechnology company focused on glycan-directed cancer therapies, has announced a significant cooperative research agreement with Hokkaido University Hospital. This partnership aims to advance the development of GNX1021, a cutting-edge antibody-drug conjugate (ADC), specifically for patients battling gastric cancer in Japan. This collaboration not only aims to refine the development of GNX1021 but lays a critical foundation for future clinical trials within the country.

The study will prioritize a retrospective analysis focused on evaluating the expression of branched Lewis B/Y (bLeB/Y) glycan antigens in gastric cancer patients. Importantly, it will also investigate the correlation between this expression and established clinical biomarkers such as HER2, CLDN18, PD-L1, and MMR. The urgency of this research is highlighted by statistics from the National Cancer Center Japan, which indicates gastric cancer as the third most prevalent cancer and fourth leading cause of cancer-related mortality in the region. In 2024 alone, Japan is estimated to see about 115,100 new cases and 39,900 fatalities due to this disease, underscoring a pressing need for innovative treatment alternatives.

This collaboration's objective is to systematically evaluate the occurrence and distribution of bLeB/Y antigen expression in Japanese gastric cancer patients, juxtaposing it with the aforementioned clinical biomarkers. The ultimate aim is to delineate the specific patient populations that will most likely respond positively to GNX1021 treatment, thereby increasing the likelihood of success in clinical settings.

Dr. Mei-Chun Yang, the CEO of GlycoNex, emphasized the importance of this collaboration, stating, "Our partnership with Hokkaido University Hospital represents a pivotal stride toward understanding how bLeB/Y expression can inform treatment pathways for gastric cancer patients. By reinforcing the scientific framework for GNX1021, our goal is to propel the development of innovative glycan-directed treatments that expand therapeutic options beyond the existing HER2 and CLDN18 frameworks, ultimately addressing substantial unmet needs in the field of oncology."

GNX1021 is distinguished for its powerful tumor-suppressive capabilities demonstrated across various preclinical gastric cancer models, including scenarios resistant to traditional HER2 and CLDN18-targeted therapies. Building on these promising results, GlycoNex has successfully advanced the program through essential pre-fill and toxicology assessments and is gearing up for regulatory submissions in both Taiwan and Japan. Plans are underway for initiating Phase I clinical trials in 2026, with the objective of providing a groundbreaking treatment option for gastric cancer patients who remain inadequately served by current targeted therapies.

In essence, GlycoNex, Inc., established as a clinical-stage biotechnology company (stock code: 4168), specializes in developing glycan-directed ADCs and high-quality biosimilars to facilitate the emergence of next-generation biological therapies. The flagship program, GNX1021, is a pioneering glycan-directed ADC specifically targeting branched Lewis B/Y (bLeB/Y) antigens, showcasing robust anti-tumor activity in preliminary studies. As its clinical evaluation approaches in 2026, GlycoNex is also actively advancing its SPD8 program, a biosimilar to denosumab, currently in Phase 3 clinical development aimed at addressing osteoporosis. The company's comprehensive capabilities in complex antibody manufacturing accentuate its commitment to producing scalable, innovative treatments for patients globally.

For further insights into GlycoNex’s ongoing advancements and detailed information regarding their projects, interested parties can visit GlycoNex’s official site.