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GlycoNex Receives PMDA Approval in Japan to Initiate First-in-Human Phase 1 Trial of GNX1021 in Gastrointestinal Cancers
GlycoNex, Inc. (4168, hereinafter referred to as GNX), clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has approved the initiation of a first-in-human (FIH) Phase 1 clinical trial of GNX1021, the company's lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal cancers.
About this update from Glyconex, Inc.
[{"type":"text","content":"GNX1021 is a glycan-targeting antibody-drug conjugate designed to address tumor heterogeneity in gastrointestinal cancers","length":121,"tagName":"p","attribs":{}},{"type":"text","content":"NEW TAIPEI CITY, Taiwan, April 14, 2026 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has approved the initiation of a first-in-human (FIH) Phase 1 clinical trial of GNX1021, the company's lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal cancers.","length":505,"tagName":"p"},{"type":"image","alt":"GlycoNex, Inc. (PRNewsfoto/GlycoNex, Inc.)","displaySize":"","headline":null,"caption":"GlycoNex, Inc. (PRNewsfoto/GlycoNex, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":377,"url":"https://media.zenfs.com/en/prnewswire.com/72f55fbc984af5a9b79660de98aaf4d4"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/8XMKVdEFZLutQPcAZKhfTw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTY2NA--/https://media.zenfs.com/en/prnewswire.com/72f55fbc984af5a9b79660de98aaf4d4","width":400,"height":377}},"href":"https://mma.prnewswire.com/media/2420764/GlycoNex_Inc.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"This milestone marks GlycoNex's transition into clinical-stage development for its proprietary glycan-targeting ADC platform and represents a significant step toward addressing high unmet need in gastric and other gastrointestinal malignancies.","length":248,"tagName":"p"},{"type":"text","content":"The multi-center, multinational Phase 1 study in patients with advanced gastrointestinal cancers is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of GNX1021 and to establish a recommended dose range for subsequent clinical development. The first phase of the trial will be conducted in Japan and Taiwan. Patient enrollment in Japan is expected to begin in June 2026. GlycoNex plans to submit an Investigational New Drug (IND) application in Taiwan in June 2026, with enrollment anticipated to begin in the third quarter of 2026.","length":570,"tagName":"p"},{"type":"text","content":""PMDA approval to initiate our...