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

TAIPEI, Taiwan, Sept. 02, 2025 (GLOBE NEWSWIRE) -- OBI Pharma, a clinical-stage oncology company (4174.TWO), today announced the initiation of a Phase 1/2 clinical trial of OBI-902, an antibody-drug conjugate (ADC) targeting TROP2 (Trophoblast cell-surface antigen 2), an antigen overexpressed in multiple tumor types. OBI-902 is the first OBI- developed ADC that uses our proprietary Glycan ADC enabling technology.

OBI plans to enroll patients with advanced solid tumors with the objective of verifying the safety, pharmacokinetics, and preliminary efficacy profile of OBI-902 in these patient populations. Apostolia M.Tsimberidou, MD, PhD, of MD Anderson Cancer Center in Houston, TX. USA is the lead investigator for the study.

OBI-902 is a novel TROP2 ADC utilizing OBI’s proprietary GlycOBI^® ADC enabling technology. At the 2025 American Association for Cancer Research (AACR) meeting, OBI presented data demonstrating enhanced linker-payload stability, favorable pharmacokinetics with superior and durable antitumor activities of OBI-902 in numerous in-vitro and animal studies compared to other TROP2 ADCs  ,

Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, added, “We are excited to initiate this first in human study of OBI-902. This is an important company milestone and highlights our commitment to building and strengthening the novel OBI Pharma pipeline. We also look forward to obtaining clinical data from this first GlycOBI^®-conjugated ADC. We thank the patients and the investigators for their efforts and dedication.”

About OBI-902

OBI-902 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells and with a drug-antibody ratio (DAR) of 4. TROP2 is highly expressed in a variety of solid tumors such as breast, biliary, ovarian, gastric, and many other cancer types, rendering it an ideal target for cancer therapy.

OBI-902 is a novel site-specific glycan-conjugated ADC using OBI’s proprietary GlycOBI^® platform, which provides improved stability and enhanced hydrophilicity. OBI-902 demonstrated remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in various animal models. The IND of OBI-902 was cleared by the U.S. FDA on April 30, 2025.

OBI has licensed the TROP2 targeting antibody from Biosion, Inc. () since December 2021, holding exclusive rights worldwide except in China. OBI holds worldwide commercial rights to OBI-902, with the exception of the rights pertaining to the antibody in China. OBI has not granted Biosion with any right to any OBI ADC, including the OBI-902 product.

About GlycOBI ^®

OBI has developed a unique glycan-based site-specific ADC technology (GlycOBI^®), which is in a ‘Plug and Play’ format and compatible with any antibodies, linkers, and payloads in drug-antibody ratio (DAR) up to 16. Utilizing OBI’s proprietary dual-function enzyme (EndoSymeOBI^®) and linker technology (HYPrOBI^®), homogenous ADCs are manufactured with an efficient and scalable process under GMP conditions. The conjugation process of GlycOBI^® avoids disrupting the antibody structure and ensures the ADC has similar biophysical characteristics to the native antibody. Furthermore, OBI’s linker technology has improved conjugation efficiency of the payload, reduced aggregation propensity, which provides advantages on manufacturing ADC products. GlycOBI^® conjugated ADCs have overcome the limitations of traditional ADCs and achieved better antitumor activity and stability in various in vivo animal studies. GlycOBI^®, EndoSymeOBI^®, and HYPrOBI^® are part of the armamentarium of OBI’s Obrion™ ADC Enabling Technologies that also include ThiOBI^® and GlycOBI DUO™.

About OBI Pharma

OBI is a clinical stage global oncology company that is headquartered in Taiwan and established in 2002. Its mission, together with its wholly owned subsidiary OBI Pharma USA, Inc., is to develop novel therapeutic agents for patients with high unmet medical needs.

OBI’s primary focus is the development of novel ADCs, including the first-generation cysteine-based TROP2 ADC, OBI-992. Using the company’s proprietary ADC enabling technology, GlycOBI^®, powered by EndoSymeOBI^® and HYPrOBI^®; OBI has created its next-generation novel ADC pipeline, including monospecific: OBI-902 (TROP2), OBI-904 (Nectin-4),bispecific single payload (HER2 x TROP2), and bispecific, dual payload (cMET x HER3) ADCs. To broaden the applicability of linker technology, HYPrOBI^®, OBI further developed a novel ThiOBI^® platform to enable irreversible cysteine-based conjugation. Additionally, OBI’s pipeline includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme that is highly expressed in tumors. Additional information can be found at .

GlycOBI^®, EndoSymeOBI^®, ThiOBI^® and HYPrOBI^® are registered trademarks of OBI Pharma. Obrion™ and GlycOBI DUO™ are trademarks under registration.

OBI-902, a novel TROP2 targeted antibody-drug conjugate via GlycOBI^® platform, has favorable pharmacokinetics and sustained antitumor activities in challenging solid tumors.

^{AACR Annual Meeting 2025 Abstracts online} 

Harnessing the GlycOBI® enabling technologies: next-generation site-specific glycan ADCs with versatile DAR to enhance therapeutic index.

^{AACR Annual Meeting 2025 Abstracts online} 

Forward-Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau.

COMPANY CONTACT:

Kevin Poulos, Chief Business Officer

OBI Pharma USA, Inc.

+1 (619) 537 7698, ext. 102