VANCOUVER, BC-The United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zymeworks’ lead investigational products ZW25 and ZW33 for the treatment of ovarian cancer.
The designation qualifies Zymeworks for a number of development incentives including tax credits for clinical testing and marketing exclusivity for a period of seven years if ZW25 or ZW33 is approved for this indication.
ZW25 is Zymeworks’ lead therapeutics program and is due to begin Phase 1 clinical development in the U.S. in late August. It is a novel bi-specific antibody, developed using the company’s Azymetric™ platform, to target two different epitopes (bi-paratopic targeting) of the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on the surface of many tumour types, including a subset of breast, gastric, lung, and ovarian cancers.
ZW33 is a drug-conjugated version of ZW25 currently in development in preparation for an IND filing in early 2017.
“We are very excited with the potential of our novel engineered bispecific antibody ZW25 and its drug conjugate ZW33, as new treatment options for patients with ovarian cancer,” said Dr. Gordon Ng, Zymeworks’ chief scientific officer. “We believe ZW25’s and ZW33’s multiple differentiated mechanisms of action can be significantly more efficacious than current HER2-directed treatments for HER2 expressing cancers and can enhance the range of current treatments available to these patients.”