Zymeworks Inc announced the addition of new clinical sites in Canada and the United States for its ongoing adaptive Phase 1 study of the company’s lead clinical candidate, ZW2.
“We are pleased to announce the expansion of our clinical network and increased patient access to this promising compound,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “By adding selected centers with a demonstrated commitment to oncology excellence, we anticipate accelerating the development of ZW25 thereby allowing us to more quickly identify the optimal route to regulatory review.”
In order to initiate clinical testing in Canada, Zymeworks submitted a clinical trial application (CTA) to Health Canada. After a 30-day review period, Zymeworks was notified that Health Canada had completed its review and the Company is in the process of activating multiple sites across the country to participate in the ongoing Phase 1 study of ZW25. In addition, Zymeworks is expanding the number of clinical sites in the United States.
“The interest and enthusiasm in ZW25 from the clinical community has been gratifying, and we are excited to allow more clinicians first-hand experience with ZW25,” said Diana Hausman, M.D., Chief Medical Officer of Zymeworks. “We are pleased with the momentum we have developed, and are looking forward to advancing ZW25 into later stages of development.”
Status of Phase 1 Testing for ZW25
Enrollment in the dose-escalation portion of the Phase 1 study has been completed. The Company has reported results from this portion of the trial showing encouraging tolerability and anti-tumor activity in heavily pretreated patients with HER2-expressing cancers, including breast and gastric cancers. Additional clinical data is expected to be announced this year at upcoming medical meetings.
In the second part of the study, expansion cohorts are being enrolled to further assess ZW25’s tolerability and anti-cancer activity. The five cohorts include patients with: HER2 high breast, HER2 high gastric, HER2 intermediate breast, HER2 intermediate gastric, and other HER2-expressing cancers.
About ZW25
ZW25, Zymeworks’ lead product candidate, is being evaluated in a Phase 1 clinical trial in the United States. It is a bispecific antibody, based on Zymeworks’ Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function and has led to encouraging anti-tumor activity in patients with HER2-expressing breast and gastric cancer. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2.
