VANCOUVER – Zymeworks Inc . (NASDAQ:), a biotechnology firm specializing in biotherapeutics, has announced the U.S. Food and Drug Administration’s (FDA) accelerated approval of Ziihera (zanidatamab-hrii) for HER2-positive biliary tract cancer (BTC). This approval marks the first FDA endorsement of a dual HER2-targeted bispecific antibody for this cancer type, providing a new option for patients who have exhausted other treatments.
Ziihera’s approval was based on a 52% objective response rate and a median duration of response of 14.9 months from the HERIZON-BTC-01 clinical trial. While this accelerated approval is contingent upon further verification in a confirmatory trial, it represents a significant milestone for Zymeworks, validating their proprietary Azymetric™ technology used in the drug’s development.
Zymeworks has also secured a $25 million milestone payment from Jazz Pharmaceuticals (NASDAQ:) following the FDA approval, with the potential for up to $500 million more in regulatory milestones, as well as additional commercial milestones and tiered royalties on net sales.
The approval of Ziihera offers a chemotherapy-free treatment alternative for patients with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) BTC, as detected by an FDA-approved test. This bispecific antibody works by binding to two extracellular sites on the HER2 receptor, leading to internalization and reduction of the receptor on tumor cells, potentially inhibiting tumor growth and inducing cell death.
Zanidatamab is currently under review in other regions, including China and Europe, and is being investigated in various tumor types beyond BTC, with ongoing Phase 3 trials in gastroesophageal adenocarcinomas and metastatic breast cancer.
The company’s collaboration with Jazz Pharmaceuticals and BeiGene (NASDAQ:), Ltd. aims to advance zanidatamab’s development and commercialization globally. Zymeworks continues to focus on a diverse pipeline of novel therapeutics for difficult-to-treat cancers, with several candidates in different development stages.
This news is based on a press release statement and does not reflect the views of any financial analysts or medical experts.
In other recent news, Zymeworks Inc. has seen significant advancements in its clinical programs, including bispecific T cell engagers and antibody-drug conjugates (ADCs). Leerink Partners has upgraded Zymeworks’ stock rating from Market Perform to Outperform, raising the price…
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