Zymeworks’ orphan drug ZW25 for the treatment of gastric cancer and cancer of the gastroesophageal junction (GEJ) has been granted Orphan Drug Designation by the FDA.
ZW25 is currently being evaluated in an adaptive Phase 1 clinical trial in patients with advanced HER2 expressing cancers.
ZW25 is a bispecific antibody that is designed to simultaneously bind two non-overlapping epitopes, of HER2 resulting in dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and enhanced effector function.
The drug was also granted Orphan Drug Designation intended for ovarian cancer last year.
About gastric cancer
Gastric (stomach) cancer is a disease in which malignant (cancer) cells form in the lining of the stomach. The stomach is in the upper abdomen and helps digest food.
Almost all gastric cancers are adenocarcinomas (cancers that begin in cells that make and release mucus and other fluids). Other types of gastric cancer are gastrointestinal carcinoid tumors, gastrointestinal stromal tumors, and lymphomas.
Gastric cancer is often diagnosed at an advanced stage because there are no early signs or symptoms.