Zymeworks obtains orphan drug designation from the European Commission for zanidatamab, a bispecific antibody targeting HER2, in the treatment of gastric cancer
20 November 2020
Zymeworks Inc., a clinical-stage biopharmaceutical company that develops multifunctional biotherapeutics, announced that the European Commission (EC) has granted the orphan drug designation for zanidatamab, its experimental bispecific antibody targeting the HER2 receptor, for the treatment of patients with gastric cancer.
"The recognition by the European Commission and the European Medicines Agency of the potential benefit provided by zanidatamab in terms of the treatment of gastric cancers expressing HER2 is an encouragement to us, as we continue to strengthen our development activity clinic globally, "said Diana Hausman, MD, medical manager at Zymeworks.
The EC grants orphan drug designation to treatments which represent a significant advantage over existing treatments, which are intended for the treatment, prevention or diagnosis of a chronic disabling or life-threatening disease, and whose prevalence in the European Union (EU) is less than 5 in 10,000 people. The orphan drug designation gives companies certain advantages, including 10 years of market exclusivity after obtaining regulatory approval, lower regulatory costs, assistance in the development of the clinical protocol and access to research grants.
“While gastric cancer is a rare disease, European countries have the highest incidence rates of any western country,” said James Priour, senior vice president, business affairs, Zymeworks. "The orphan drug designation granted by the European Commission to zanidatamab is a major step in bringing this promising investigational drug to patients, in Europe and around the world," he added.
Zymeworks previously received orphan drug designation from the FDA for zanidatamab for the treatment of gastric, bile duct and ovarian cancers, as well as two fast-track designations.
Zanidatamab is a bispecific antibody, based on the Azymetric ™ platform from Zymeworks, capable of simultaneously binding two non-overlapping epitopes of the HER2 receptor, known as biparatopic binding. This unique pattern results in numerous mechanisms of action, including the double blocking of HER2 signals, increased binding, removal of the HER2 protein from the cell surface, as well as potent effector function leading to stimulation of the HER2 protein. anti-tumor activity in patients. Zymeworks is developing zanidatamab globally in several clinical studies (Phase 1, Phase 2, and registration trial) as a targeted treatment option for patients with solid tumors expressing HER2. The FDA has granted two fast-track designations to zanidatamab - one as a sole agent for the treatment of refractory biliary tract cancer, the other in combination with standard of care chemotherapy, for the treatment of adenocarcinoma gastroesophageal. Zanidatamab has also received orphan drug designations from the FDA for the treatment of biliary, gastric and ovarian cancers, in addition to the orphan drug designation for the treatment of gastric cancer from the European Medicines Agency. .
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation, multi-functional biotherapeutics. Zymeworks' therapeutic platforms and its fully integrated drug development engine enable the precision design of highly differentiated product candidates. Zymeworks' main clinical candidate, zanidatamab (ZW25) is a new Azymetric ™ bispecific antibody currently in clinical trial for registration, for the treatment of HER2 + refractory cancer of the bile ducts, as well as several Phase 2 clinical trials for the treatment of HER2 + gastroesophageal and breast cancers. Zymeworks' second clinical candidate, ZW49, is a bispecific antibody-drug conjugate in Phase 1 clinical development that combines the unique design and antibody backbone of zanidatamab with the ZymeLink ™ binding cytotoxin from Zymeworks. Zymeworks is also developing a broad preclinical portfolio in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms serve as leverage for strategic partnerships concluded with nine biopharmaceutical companies. For more information, please visit Zymeworks is also developing a broad preclinical portfolio in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms serve as leverage for strategic partnerships concluded with nine biopharmaceutical companies. For more information, please visit Zymeworks is also developing a broad preclinical portfolio in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms serve as leverage for strategic partnerships concluded with nine biopharmaceutical companies. For more information, please visitwww.zymeworks.com .
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