OBI Pharma announces U.S. FDA clearance of IND application for a Phase 1/2 study of OBI-902, a Trop-2 targeting ADC

CAR-T Digest - August 2020

1 May 2025: OBI Pharma announces U.S. FDA clearance of IND application for a Phase 1/2 study of OBI-902, a Trop-2 targeting ADC

OBI Pharma received U.S. FDA clearance to initiate a Phase 1/2 clinical trial of OBI-902, a Trop-2 targeting antibody-drug conjugate (ADC)
The trial will evaluate safety, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors, with enrollment expected to start in the second half of 2025
OBI-902 is the first ADC to use OBI’s proprietary GlycOBI technology, which enhances linker-payload stability and improves pharmacokinetics
Preclinical data presented at AACR 2025 showed that OBI-902 demonstrated superior and durable antitumor activity compared to existing Trop-2 ADCs
This milestone positions OBI-902 as a potentially best-in-class therapy for patients with high unmet needs in advanced solid tumors