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

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.

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.” 

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 ^, . The Phase 1/2 clinical study is planned to begin enrolling patients in 2H 2025.

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}

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

^{AACR Annual Meeting 2025 Abstracts online} 

About OBI-902 

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.

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.

OBI has licensed Trop-2 targeting antibody from Biosion, Inc. () 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.

About GlycOBI^®

OBI has developed a unique glycan-based ADC technology (GlycOBI^®), which is in a ‘Plug and Play’ format and compatible with any antibodies, linkers, and payloads in various DAR. Utilizing OBI’s proprietary enzymatic technology（EndoSymeOBI®） and linker technology（HYPrOBI™), GlycOBI^® generates site-specific homogenous ADCs 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^® has overcome the limitations of traditional ADCs and achieved better antitumor activity and stability in various in vivo animal studies.

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 cancer 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 TROP-2 ADC, OBI-992. Using the company’s proprietary ADC enabling technology, GlycOBI^®, powered by EndoSymeOBI^® and HYPrOBI™; OBI has created its second generation novel ADC pipeline, including monospecific: OBI-902 （Trop-2), OBI-904 (Nectin-4), Trastuzumab-ADC (HER2), bi-specifics and dual payload ADCs. To broaden the applicability of the linker technology, HYPrOBI™, OBI further developed a next-generation ThiOBI^® platform to enable irreversible cysteine-based conjugation. Additionally, OBI’s pipeline also 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^® are registered trademarks of OBI. HYPrOBI™ is a trademark under registration.

COMPANY CONTACT:

Kevin Poulos, Chief Business Officer

OBI Pharma USA, Inc.

+1 (619 537 7698, ext. 102