On June 12, 2025 GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical-stage biotechnology company specializing in glycan-directed cancer immunotherapies, reported that its first-in-class antibody-drug conjugate (ADC), GNX1021, has demonstrated superior efficacy in preclinical studies, including potent tumor growth inhibition in gastric cancer animal models (Press release, GlycoNex, JUN 12, 2025, View Source [SID1234653859]). GNX1021 may offer a novel treatment option for gastric cancer patients who are ineligible for HER2 or CLDN18-targeted therapies, and its broad activity suggests therapeutic potential across multiple solid tumor types.
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In safety assessments, GNX1021 has completed a pilot toxicology study in cynomolgus monkeys, demonstrating a safety profile comparable to that of currently approved ADCs. GlycoNex plans to initiate GLP-compliant toxicology studies by year-end and aims to submit clinical trial applications in Taiwan and Japan in the first quarter of 2026, with first-in-human Phase I trials anticipated to commence in the second quarter.
"With our GNX1021 program advancing rapidly and backed by our deep expertise in antibody-drug development, we are actively pursuing early-stage licensing and strategic partnerships," said Dr. Mei-Chun Yang, CEO of GlycoNex. "These partnerships will provide upfront funding, mitigate development risk, and help accelerate our path to the clinic."
Recent landmark deals in the ADC field highlight the strong licensing potential of early-stage assets, with total deal sizes reaching several billion dollars. As the global ADC market exceeded USD 160 billion in 2023, GlycoNex remains committed to seizing this significant market opportunity, driving innovation in oncology, and addressing unmet medical needs worldwide. GlycoNex will actively engage in strategic collaboration discussions with international pharmaceutical partners at the BIO International Convention in June 2025.