OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of OBI-902, a Trop-2 Targeting ADC

Core Viewpoint - OBI Pharma has received FDA clearance for the investigational new drug application of OBI-902, a novel Trop-2 targeted antibody-drug conjugate, marking a significant milestone in the development of a potentially best-in-class cancer therapy for patients with advanced solid tumors [1][2][5]. Group 1: OBI-902 Overview - OBI-902 is a Trop-2-targeted antibody-drug conjugate utilizing OBI's proprietary GlycOBI technology, designed to enhance therapeutic index and stability [3][4]. - The drug carries a potent topoisomerase I inhibitor payload with a drug-antibody ratio (DAR) of 4, targeting various solid tumors such as breast, ovarian, and gastric cancers [4][5]. - The Phase 1/2 clinical study for OBI-902 is set to begin patient enrollment in the second half of 2025 [2][5]. Group 2: Clinical Trial and Efficacy - 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 [2]. - Data presented at the 2025 American Association for Cancer Research (AACR) meeting indicated enhanced linker-payload stability and superior antitumor activities of OBI-902 compared to other Trop-2 ADCs in various in-vitro and animal studies [2][5]. Group 3: GlycOBI Technology - OBI's GlycOBI platform allows for the creation of site-specific glycan-conjugated ADCs, improving stability and hydrophilicity while maintaining the biophysical characteristics of native antibodies [7]. - The technology utilizes proprietary enzymatic and linker technologies to generate homogeneous ADCs with efficient and scalable manufacturing processes [7]. Group 4: Company Background - OBI Pharma, established in 2002 and headquartered in Taiwan, focuses on developing novel cancer therapeutic agents for patients with high unmet medical needs [8]. - The company holds exclusive worldwide rights to the Trop-2 targeting antibody licensed from Biosion, Inc., except for rights pertaining to the antibody in China [6].