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 and the CDE in China, 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 and gastric cancers in the United States and for gastric cancer in the European Union.
HER2 x HER2 Bispecific Antibody Drug Conjugate (ADC)
Zanidatamab zovodotin (ZW49) is a HER2-targeted antibody drug conjugate (ADC) developed using Zymeworks’ proprietary Azymetric™ and ZymeLink™ platforms. Zanidatamab zovodotin is currently being evaluated in a Phase 1 clinical trial as a treatment for patients with locally advanced or metastatic HER2-expressing cancers that have progressed following treatment with existing approved therapies, including HER2-targeted agents.
Zanidatamab zovodotin combines the unique design of zanidatamab with a proprietary cytotoxin and cleavable linker. Zanidatamab zovodotin delivers a novel auristatin (cell-killing compound) to tumor cells by taking advantage of the enhanced antibody-HER2 internalization of zanidatamab.