OBI Pharma Gets FDA Approval for Phase 1/2 Study of OBI-902

OBI Pharma, Inc., a Taiwan-based clinical stage oncology company, has announced a significant step in cancer treatment with the U.S. Food and Drug Administration's (FDA) clearance of an investigational new drug (IND) application for their novel therapy, OBI-902. This clearance paves the way for a Phase 1/2 clinical study aimed at evaluating the therapy's potential in treating advanced solid tumors. OBI-902 is positioned as a promising Trop-2-targeted cancer therapy, addressing crucial unmet medical needs in oncology.

Heidi Wang, Ph.D., Chief Executive Officer of OBI Pharma, emphasized the company's enthusiasm for the upcoming clinical trial, designated as OBI-902-001. This trial will assess the safety, pharmacokinetics, and initial efficacy of OBI-902 in patients suffering from advanced solid tumors. The company plans to initiate patient dosing later this year.

A defining feature of OBI-902 is its reliance on OBI’s proprietary GlycOBI® technology, a leading-edge platform for developing antibody-drug conjugates (ADCs). At the recent American Association for Cancer Research (AACR) meeting, OBI Pharma presented compelling data showcasing OBI-902's improved linker-payload stability and superior pharmacokinetics, which translate into enhanced and sustained antitumor activities compared to other Trop-2 ADCs. The clinical study is anticipated to begin patient enrollment in the second half of 2025.

OBI-902 operates as a Trop-2-targeted ADC, equipped with a potent topoisomerase I inhibitor payload, which is instrumental in destroying cancer cells. It boasts a drug-antibody ratio (DAR) of 4, making it particularly effective against a variety of solid tumors, including breast, ovarian, and gastric cancers, among others. This specificity positions Trop-2 as an ideal target for therapeutic interventions in oncology.

The GlycOBI® platform represents a significant advancement in ADC technology, offering a 'Plug and Play' format that is compatible with diverse antibodies, linkers, and payloads across various DARs. By using proprietary enzymatic and linker technologies, GlycOBI® enables the production of homogeneous ADCs with maintained antibody structure and biophysical properties akin to their native counterparts. This approach enhances the therapeutic index of ADCs, providing a method for improved drug delivery and stability.

OBI Pharma's strategic licensing agreement with Biosion, Inc. has granted it exclusive rights to the Trop-2 targeting antibody worldwide, excluding China. This agreement supports OBI's efforts to commercialize OBI-902 internationally, expanding its reach to a broader patient population.

Founded in 2002, OBI Pharma is committed to advancing cancer treatment through its innovative approach to drug development. The company's focus on ADC technology is exemplified by its pioneering efforts with OBI-902 and other promising candidates in its pipeline. This includes the first-generation TROP-2 ADC, OBI-992, and a second-generation pipeline featuring various targets and mechanisms.

OBI Pharma's ambition extends beyond ADCs, with additional research into small-molecule prodrugs like OBI-3424, designed to selectively activate potent antitumor agents in the presence of specific enzymes found in tumors. This diverse pipeline highlights OBI's dedication to addressing the complex challenges of cancer treatment and improving outcomes for patients worldwide.