GlycoNex, Inc. 4168

GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the Phase III clinical trial for SPD8, a Denosumab biosimilar co-developed with Mitsubishi Gas Chemical, has successfully met its primary endpoint. Statistical analysis confirms that SPD8 demonstrated therapeutic equivalence to the reference drug, Prolia® (marketed as Pralia® in Japan). The company expects to finalize the clinical study report by the end of September, followed by a drug approval application in Japan. Jap

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.

GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical-stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that it has entered into a collaboration agreement with Nippon Kayaku Co., Ltd. ("Nippon Kayaku") to advance GNX201-ADC, a next-generation antibody-drug conjugate (ADC) candidate for the treatment of solid tumors. Under the agreement, the two companies will jointly support preclinical development activities for GNX201-

GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the last patient has received the final dose in its Phase 3 clinical study of SPD8, a biosimilar to denosumab for the treatment of osteoporosis. Developed in collaboration with Mitsubishi Gas Chemical (MGC), SPD8 is designed to address complications associated with bone metastases in patients with solid tumors and osteoporosis-related conditions. Dosing of the final patient marks a significant milestone for the program,