Zanidatamab
HER2 x HER2 Bispecific Antibody
Zymeworks’ lead product candidate, zanidatamab, is a HER2-targeted bispecific antibody developed using Zymeworks proprietary Azymetric™ platform. Zanidatamab is currently being evaluated in global Phase 1, Phase 2 and pivotal clinical trials as a best-in-class treatment for patients with HER2-expressing cancers, including biliary tract, gastroesophageal adenocarcinomas, breast, and other tumor types.
Zanidatamab simultaneously binds two distinct sites on HER2, a protein expressed on many types of cancer cells. This unique design results in multiple mechanisms of action, including dual HER2 signal blockade, increased antibody binding, receptor clustering, and removal of HER2 from the cell surface, and potent effector function.
Zanidatamab has been granted Breakthrough Therapy designation for biliary tract cancer from the FDA, as well as two Fast Track designations, one for previously treated or recurrent HER2-positive biliary tract cancer and another for first-line gastroesophageal adenocarcinoma in combination with standard of care chemotherapy. Zanidatamab also received Orphan Drug designation for the treatment of biliary tract, gastric and ovarian cancers in the United States and for gastric cancer in the European Union.