FDA grants orphan drug designation to TST001 for gastric cancer
The FDA granted orphan drug designation to TST001 for treatment of gastric and gastroesophageal junction cancers, according to the agent’s manufacturer.
An estimated 120,300 people in the United States have gastric cancer, according to SEER data. Gastric cancers that express Claudin18.2 typically are treated with surgical resection, chemotherapy or immunotherapy.
TST001 (Transcenta Holding Limited) is an anti-Claudin18.2 monoclonal antibody.
Preclinical and clinical data showed TST001 had potent anti-tumor activity in tumor models of gastric cancer and patients with gastric cancer who express Claudin18.2.
A phase 1 trial is underway to evaluate the agent for patients with gastric or gastroesophageal junction cancers.
“[Gastric/gastroesophageal junction cancer] is a serious, life-limiting orphan disease in the US,” Michael Shi, executive vice president, head of global research and development and chief medical officer of Transcenta, said in a company-issued press release. “The treatment of [this malignancy] represents an urgent unmet clinical need globally. This orphan drug designation by the U.S. FDA ... marks an important milestone in the global development of TST001.”
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.
Read more about