FDA Clears IND of OBI-902, Trop-2 ADC for Advanced Solid Tumors

US FDA

• The FDA has cleared the investigational new drug (IND) application for OBI-902.
• With this clearance, a phase 1/2 study in advanced solid tumors will proceed.
• OBI-902 is a novel Trop-2-targeting antibody-drug conjugate (ADC).

The IND application for OBI-902, a Trop-2-targeting ADC, has been cleared by the FDA, and a phase 1/2 study will investigate the agent in advanced solid tumors.¹

“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,” said Heidi Wang, PhD, chief executive officer of OBI Pharma, in a press release.

The phase 1/2 study plans to begin enrolling patients in the second half of 2025.

About OBI-902

OBI-902 is a Trop-2-targeted ADC carrying a topoisomerase I inhibitor payload with a drug-antibody ratio (DAR) of 4. The agent uses OBI’s proprietary GlycOBI platform, a unique glycan-based ADC technology providing improved stability and enhanced hydrophilicity, according to OBI.

Preclinical data on OBI-902 was presented at the 2025 American Association for Cancer Research (AACR) meeting. In in vitro and animal studies, OBI-902 demonstrated enhanced linker-payload stability, favorable pharmacokinetics, and durable antitumor activity. One study evaluated OBI-902 in xenograft models of non–small cell lung cancer, pancreatic cancer, gastric cancer, and colorectal cancer, where Trop-2 is often overexpressed.² Here, OBI-902 showed 3.6- to 6.2-fold better tumor volume reduction than benchmarks.

A second study looked at OBI-902 and OBI-904, a Nectin-4-targeting ADC with a topoisomerase I inhibitor payload and a DAR of 8 and found that both agents maintained their stability and avoided antibody aggregation in animal models.

OBI intends to submit an IND application for OBI-904 later this year.³

REFERENCES:

1. OBI Pharma announces U.S. FDA clearance of IND application for a phase 1/2 study of OBI-902, a Trop-2 targeting ADC. News release. OBI Pharma. May 1, 2025. Accessed May 1, 2025. https://tinyurl.com/4p7pk9fs

2. Hsu RY, Lu CH, Shia CS, et al. OBI-902, a novel TROP2 targeted antibody-drug conjugate via GlycOBI platform, has favorable pharmacokinetics and sustained antitumor activities in challenging solid tumors. Presented at American Association for Cancer Research Annual Meeting; April 25-30, 2025; Chicago, IL. Abstract 4356/21.

3. Huang TY, Fung KS, Huang YC, et al. Harnessing the GlycOBI enabling technologies: next-generation site-specific glycan ADCs with versatile DAR to enhance therapeutic effect. Presented at American Association for Cancer Research Annual Meeting; April 25-30, 2025; Chicago, IL. Abstract 1799/18.