FDA Approves OBI-992 for Phase 1/2 Cancer Therapy Trial

A clinical stage oncology company, OBI Pharma, has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2 study for its innovative cancer treatment, OBI-992. This novel antibody-drug conjugate (ADC) is designed to target TROP2, a protein frequently found in various solid tumors, including lung and gastric cancer.

The study aims to assess the safety, pharmacokinetics, and initial efficacy of OBI-992. The company intends to enroll patients suffering from advanced solid tumors, with a focus on non-small cell lung cancer, small cell lung cancer, and gastric cancer. OBI Pharma's Chief Medical Officer, Dr. Wayne Saville, has expressed anticipation for the clinical trial, which is set to begin in early 2024.

Heidi Wang, OBI Pharma’s CEO, highlighted the unique design and engineering of OBI-992, which has shown exceptional preclinical efficacy and favorable safety in numerous studies. The ADC utilizes a hydrophilic, enzyme-cleavable linker that remains stable in circulation but releases its potent payload within tumor cells, demonstrating significant antitumor effects and improved pharmacokinetics.

The TROP2 targeting antibody was obtained from Biosion, Inc., and OBI Pharma holds the commercial rights for OBI-992 outside of China. OBI-992 is part of OBI Pharma's broader mission to develop pioneering cancer therapeutics for patients with significant unmet medical needs.

Founded in 2002 and based in Taiwan, OBI Pharma is dedicated to advancing its promising therapeutics into clinical trials. The company's portfolio includes a range of immuno-oncology agents and ADC pipelines targeting various cancer markers, as well as a small-molecule prodrug that selectively releases a potent antitumor agent in the presence of specific enzymes.

While the company is optimistic about the potential of OBI-992, it acknowledges the inherent uncertainties of clinical trials and the development process. OBI Pharma continues to monitor and manage the risks associated with its research and development activities, ensuring transparency and compliance with regulatory standards.