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]

Core Insights - OBI Pharma and TegMine Therapeutics have entered into a Master Services Agreement (MSA) to collaborate on antibody-drug conjugates (ADCs) [1][2] - The partnership aims to leverage OBI's GlycOBI ADC enabling technologies to identify ADC therapeutic candidates for clinical development [2][3] Company Overview - OBI Pharma is a clinical-stage global oncology company based in Taiwan, established in 2002, focusing on developing novel cancer therapies for patients with high unmet medical needs [5] - TegMine Therapeutics, founded in 2017 and based in San Francisco, specializes in developing next-generation antibody-based therapies targeting cancer-associated glycans and glycoproteins [8][9] Technology and Innovation - OBI's GlycOBI technology is a unique glycan-based ADC platform that is compatible with various antibodies, linkers, and payloads, allowing for site-specific homogenous ADCs [4] - The GlycOBI platform utilizes proprietary enzymatic and linker technologies to enhance conjugation efficiency and reduce aggregation propensity, leading to improved antitumor activity and stability [4][6] Strategic Collaboration - The collaboration is expected to combine the strengths of both companies, with OBI's ADC technology complementing TegMine's focus on targeting cancer-specific glycans [3] - Both companies anticipate developing ADCs with unprecedented tumor specificity and therapeutic impact, addressing significant medical needs [3]

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].