GlycoNex Inc (TPEx:4168), a Taiwan-based, clinical-stage biopharmaceutical company, announced on Sunday that the first participant 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.
This marks the product's transition from preclinical development into the clinic and initiates the generation of first human data for GlycoNex's lead oncology asset.
The FIH study, a multinational, multicentre Phase I trial, is being carried out in Japan and Taiwan in patients with advanced solid tumours, evaluating GNX1021 across multiple dose levels for safety and tolerability, pharmacokinetics, immunogenicity, preliminary anti-tumour activity, and the recommended dose for subsequent development. Data from the study will inform dose selection and future development strategy.
GlycoNex intends to explore potential regional and global licensing, co-development, and other strategic collaboration opportunities for GNX1021.
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