FDA Approves OBI-992 Phase 1/2 Trial IND Application

OBI Pharma, a Taiwan-based clinical stage biotechnology firm specializing in oncology, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1/2 clinical trial for OBI-992, an innovative antibody-drug conjugate (ADC) designed to treat cancer. The therapy is specifically aimed at TROP2, a protein that is frequently found in various solid tumor types, including lung, breast, ovarian, and gastric cancers.
The clinical study is set to include patients with advanced solid tumors such as non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC), with potential for expansion to other cancer types. OBI Pharma's Chief Medical Officer, Dr. Wayne Saville, has expressed anticipation for the trial, emphasizing the drug's potential for best-in-class status in terms of safety, pharmacokinetics, and preliminary efficacy.
Heidi Wang, Ph.D., CEO of OBI Pharma, highlighted the drug's preclinical performance, noting its superior efficacy, safety, and stability in in-vivo studies. OBI-992 is engineered with a hydrophilic, enzyme-cleavable linker that ensures stability in the bloodstream while enabling the release of a potent cytotoxic payload within tumor cells. The targeting antibody for TROP2 was licensed from Biosion, Inc. in December 2021, with OBI Pharma holding the commercial rights for the drug outside of China.
OBI-992 is part of OBI Pharma's broader pipeline, which includes novel immuno-oncology agents and ADC platforms targeting various cancer markers. The company, founded in 2002, is dedicated to developing innovative therapeutics for patients with significant unmet medical needs.
The company's pipeline also encompasses a first-in-class AKR1C3-targeted small-molecule prodrug, OBI-3424, which is designed to release a potent DNA-alkylating antitumor agent in the presence of the AKR1C3 enzyme. OBI Pharma's commitment to advancing cancer therapeutics is evident in their comprehensive approach to drug development, targeting a range of cancer markers with their ADC platforms.