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FDA grants orphan drug designation to OBI-999 for gastric cancer

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The FDA granted orphan drug designation to the antibody-drug conjugate OBI-999 for the treatment of gastric cancer, according to the agent’s manufacturer.

OBI-999 (OBI Pharma) targets Globo H, a glycolipid antigen expressed in up to 15 epithelial cancers.

Enrollment is underway for a phase 1/phase 2 trial designed to evaluate the safety and efficacy of OBI-999 for patients with locally advanced or metastatic solid tumors, including gastric, pancreatic, esophageal and colorectal cancers. Apostolia M. Tsimberidou, MD, PhD, tenured professor in the department of investigational cancer therapeutics at The University of Texas MD Anderson Cancer Center, will serve as principal investigator.

“Advanced gastric cancer is an orphan disease where targeted therapies are lacking for the majority of patients,” Tillman Pearce, MD, chief medical officer at OBI Pharma, said in a company-issued press release.”OBI-999 ... has demonstrated high effectiveness in xenograft models of metastatic gastric cancer that overexpress Globo H. Clinical development of this agent will be guided by evaluation of patients based on a validated Globo H immunohistochemistry assay, which will allow selection of patients whose tumors overexpress this tumor antigen for clinical investigation.”

This is the second orphan drug designation for OBI-999 in the past several weeks. The FDA granted the designation to the agent in December for treatment of pancreatic cancer.

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.