OBI Pharma, a clinical-stage oncology company, received FDA clearance for an Investigational New Drug (IND) application for OBI-902, a novel Trop-2-targeted antibody-drug conjugate (ADC). The company will initiate a Phase 1/2 clinical trial in patients with advanced solid tumors in the second half of 2025. This IND clearance allows OBI Pharma to advance a potentially best-in-class Trop-2 ADC using their proprietary GlycOBI® technology into clinical testing.
This development is notable because Trop-2 is a promising target for cancer therapy due to its high expression in various solid tumors, including breast, ovarian, and gastric cancers. OBI-902 leverages the GlycOBI® platform, which preclinical data suggest may enhance stability, improve pharmacokinetics, and increase efficacy compared to existing Trop-2 ADCs. Successfully translating these preclinical findings to clinical benefit could significantly impact the treatment landscape for these cancers.
OBI-902 utilizes a topoisomerase I inhibitor payload with a drug-antibody ratio (DAR) of 4. Data presented at the 2025 American Association for Cancer Research (AACR) meeting demonstrated enhanced linker-payload stability, favorable pharmacokinetics, and superior antitumor activity in preclinical models. The upcoming Phase 1/2 study will assess the safety, pharmacokinetics, and preliminary efficacy of OBI-902 in patients with advanced solid tumors.
The IND clearance for OBI-902 marks a critical step for OBI Pharma and its GlycOBI® platform. Positive clinical results from the upcoming Phase 1/2 trial would validate this technology, potentially paving the way for further development of other ADCs in OBI’s pipeline and offering new treatment options for patients with advanced solid tumors. This also positions OBI Pharma competitively within the rapidly expanding ADC field.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
