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OBI-902 is the first ADC utilizing OBI’s proprietary GlycOBI® ADC enabling technology
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TAIPEI, Taiwan, May 01, 2025 (GLOBE NEWSWIRE) — OBI Pharma, Inc. (“OBI”), a clinical stage oncology company（4174.TWO), today announced that the U.S. Food and Drug Administration (FDA） has cleared an investigational new drug （IND） application for OBI-902, to conduct a Phase 1/2 study. OBI plans to enroll patients with advanced solid tumors. This IND clearance represents a significant milestone for OBI-902, bringing forward a potentially best-in-class Trop-2 -targeted cancer therapy for patients with high unmet medical needs.
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OBI’s Chief Executive Officer, Heidi Wang, Ph.D. noted, “The impending OBI-902-001 clinical trial intends to evaluate the safety, pharmacokinetics, and preliminary efficacy of OBI-902 in patients with advanced solid tumors. We are very excited to begin dosing patients in our Phase 1/2 clinical study of OBI-902 later this year.”
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OBI-902 is a novel Trop-2 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 Trop-2 ADCs 1,
2. The Phase 1/2 clinical study is planned to begin enrolling patients in 2H 2025.
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OBI-902, a novel TROP-2 targeted antibody-drug conjugate via GlycOBI® platform, has favorable pharmacokinetics and sustained antitumor activities in challenging solid tumors.
AACR Annual Meeting 2025 Abstracts online
https://www.abstractsonline.com/pp8/#!/20273/presentation/1103
2 Harnessing the GlycOBI® enabling technologies: next-generation site-specific glycan ADCs with versatile DAR to enhance therapeutic index.
AACR Annual Meeting 2025 Abstracts online https://www.abstractsonline.com/pp8/#!/20273/presentation/3007
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About OBI-902
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OBI-902 is a Trop-2-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. Trop-2 is highly expressed in a variety of solid tumors such as breast, ovarian, gastric, and many other cancer types, rendering it an ideal target for cancer therapy.
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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. IND of OBI-902 was submitted to the U.S. FDA on March 31, 2025, and the IND was cleared on April 30, 2025.
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OBI has licensed Trop-2 targeting antibody from Biosion, Inc. (www.biosion.com) since December 2021, holding exclusive rights worldwide except in China. OBI holds worldwide commercial rights to OBI-902, to the exception of the rights pertaining to the antibody in China.
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