Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of cancer, announced that 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. Orphan drug 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 industry-leading 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 tumor 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 Gordon Ng, Ph.D., Chief Scientific Officer of Zymeworks. “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.”
“We’re pleased that the FDA has recognized the significant need for new and better therapies for women with ovarian cancer, which remains the leading cause of death due to gynecological malignancies,” said Diana Hausman, M.D., Chief Medical Officer of Zymeworks. “The granted orphan drug designations underscore the potential of both ZW25 and ZW33 in addressing this important unmet medical need. We are looking forward to initiating clinical development for this indication in the very near future.”
