OBI Pharma Announces Phase 1/2 Study Initiation for OBI-902, a TROP2 Targeted Antibody-Drug Conjugate Therapy (ADC) in Advanced Solid Tumors

Core Viewpoint - OBI Pharma has initiated a Phase 1/2 clinical trial for OBI-902, the first antibody-drug conjugate (ADC) utilizing its proprietary GlycOBI® technology, targeting TROP2, an antigen overexpressed in various tumors [1][2][3] Group 1: OBI-902 Overview - OBI-902 is a TROP2-targeted ADC that carries a potent topoisomerase I inhibitor payload with a drug-antibody ratio (DAR) of 4, making it suitable for treating solid tumors such as breast, biliary, ovarian, and gastric cancers [4][5] - The ADC is designed using OBI's GlycOBI platform, which enhances stability and hydrophilicity, demonstrating significant antitumor efficacy and improved pharmacokinetic characteristics in animal models [5][10] Group 2: Clinical Trial Details - The clinical trial aims to enroll patients with advanced solid tumors to assess the safety, pharmacokinetics, and preliminary efficacy of OBI-902 [2] - The lead investigator for the study is Dr. Apostolia M. Tsimberidou from MD Anderson Cancer Center [2] Group 3: Technology and Development - OBI's GlycOBI technology allows for site-specific conjugation of ADCs, compatible with various antibodies, linkers, and payloads, achieving a DAR of up to 16 [7] - The technology improves conjugation efficiency, reduces aggregation, and maintains the biophysical characteristics of the native antibody, leading to better antitumor activity and stability compared to traditional ADCs [7][10] Group 4: Company Background - OBI Pharma, established in 2002 and headquartered in Taiwan, focuses on developing novel therapeutic agents for patients with high unmet medical needs [8] - The company holds exclusive worldwide rights to OBI-902, except for rights pertaining to the antibody in China, which is licensed from Biosion, Inc. [6]