On the 1st, OBI Pharma announced that its investigational drug OBI-902 has received approval from the U.S. FDA to begin a Phase I/II clinical trial, with plans to recruit patients with advanced solid tumors in the second half of the year. This innovative Trop-2 ADC drug leverages OBI Pharma’s proprietary GlycOBI ADC platform technology.

OBI Pharma CEO Heidi Wang stated that the upcoming OBI-902-001 clinical trial aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of OBI-902 in patients with advanced solid tumors. At this year’s American Association for Cancer Research (AACR) Annual Meeting, OBI Pharma presented data demonstrating that OBI-902, in both in vitro and animal studies, exhibited superior linker-drug stability, favorable pharmacokinetic profiles, and exceptional, sustained anti-tumor activity when compared to other Trop-2 ADCs currently on the market. Patient recruitment for the Phase I/II study is scheduled to begin in the second half of this year.

OBI-902 is an antibody-drug conjugate (ADC) targeting Trop-2 and delivers a potent topoisomerase inhibitor payload to eliminate tumor cells. Trop-2 is highly expressed in various solid tumors, including breast, ovarian, and gastric cancers, making it an attractive target for cancer therapy.

OBI-902 is developed using OBI Pharma’s exclusive GlycOBI platform, which enables site-specific glyco-conjugation of the ADC. This design enhances the molecule’s stability and hydrophilicity, demonstrates a strong safety profile across multiple animal models, improves pharmacokinetic properties, and delivers remarkable anti-tumor efficacy.

Resource: 浩鼎獲FDA核准 H2啟動新藥臨床