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Investing.com -- Zymeworks Inc (NASDAQ:ZYME) stock fell 9.1% premarket Tuesday after the clinical-stage biotechnology company announced it would voluntarily discontinue clinical development of ZW171, a T cell engager designed to target gynecological, thoracic, and digestive system cancers.
The decision came after completing the planned cohorts of the dose escalation portion of the Phase 1 trial in patients with ovarian cancer and non-small cell lung cancer. Zymeworks determined that further dose evaluation "would be unlikely to support a benefit-risk profile consistent with the desired monotherapy target product profile."
While cytokine release syndrome was well-managed in the study, the company encountered dose-limiting toxicities consistent with mesothelin-related on-target off-tumor toxicity. Mesothelin, the target of ZW171, is described by the company as "a well-recognized but historically challenging target."
"While this is a disappointing outcome given the promising preclinical activity observed with ZW171, we are deeply grateful to the patients, providers, and caregivers for their support and participation in the ZW171 Phase 1 study," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks.
The company stated that ongoing participants in the Phase 1 trial will continue treatment at their investigator’s discretion, with discontinued participants continuing safety follow-up according to study protocol.
Zymeworks emphasized it will continue advancing its broader product pipeline, including the ongoing Phase 1 trial of ZW191 and plans to initiate a Phase 1 study for ZW251 in 2025. The company is also preparing an IND filing for ZW209, a DLL3-directed trispecific T cell engager, planned for the first half of 2026.
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