VANCOUVER, BC-Zymeworks Inc. reports that the U.S. Food and Drug Administration has granted an orphan drug designation to its lead product candidate, ZW25, as a treatment for gastric cancer, including cancer of the gastroesophageal junction.
ZW25 is currently being evaluated in an adaptive Phase 1 clinical trial in the U.S., based on the company’s Azymetric platform. It is a bispecific antibody that can simultaneously bind two non-overlapping epitopes, known as biparatopic binding, of HER2 resulting in dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and enhanced effector function. These combined mechanisms of action have led to significant anti-tumor activity in preclinical models.
According to company president and CEO Dr. Ali Tehrani, gastric cancer represents ZW25’s second orphan drug designation, in addition to ovarian cancer, which was granted last year.
“Gastric cancer is the fifth most common cancer in the world, and we believe ZW25 has the potential to address the significant unmet medical need that exists for patients with this disease,” he said.
Dr. Diana Hausman, Zymeworks’ chief medical officer, adds that ZW25 has demonstrated encouraging anti-tumour activity in preclinical models of gastric cancer.
“We are excited about the opportunity to advance the development of ZW25, which is currently being evaluated in a first in human Phase 1 clinical trial in the U.S. in patients with advanced HER2 expressing cancers, including gastric/GEJ tumors,” she said.
The FDA grants orphan drug designation to biological products that are intended to treat a rare disease or condition, which is generally defined as affecting a patient population of fewer than 200,000 people in the United States. Orphan drug designation provides the sponsor certain financial incentives, including tax credits, the waiver of associated application fees, and a period of marketing exclusivity if the product candidate receives the first marketing approval for the indication for which it has such designation.
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