NEW YORK – Jazz Pharmaceuticals has exercised an option under a licensing and collaboration agreement with Zymeworks to develop and commercialize the HER-2-targeted bispecific antibody zanidatamab, the companies said Wednesday.
Under the terms of the agreement inked in October, Dublin, Ireland-based Jazz will make a one-time payment of $325 million to Zymeworks in Q4 2022 to exercise the option in the US, Europe, Japan, and other territories except for where it has been licensed previously to BeiGene.
Jazz has already paid $50 million upfront in the deal. Vancouver, Canada-headquartered Zymeworks is also eligible to receive up to $1.76 billion in additional regulatory and commercial milestone payments. Further, if zanidatamab garners regulatory approval, Zymeworks is eligible for tiered royalties between 10 percent and 20 percent on net sales.
Jazz made public its decision to exercise its option on zanidatamab after Zymeworks reported positive data from the HERIZON-BTC-01 Phase IIb open-label trial earlier this week. In the study, 41.3 percent of patients with previously treated, HER2-amplified biliary tract cancers responded to zanidatamab as determined by independent central review. The median duration of response was 12.9 months and researchers observed no new safety signals with the drug.
"The compelling top-line clinical data from the pivotal trial in patients with [biliary tract cancer] highlight zanidatamab's potential to transform the current standard of care," Rob Iannone, Jazz executive VP and global head of R&D, said in a statement. "While our initial focus will be on the ongoing clinical programs in [biliary tract cancer] and [gastroesophageal adenocarcinoma], these data add to the growing body of evidence that zanidatamab has anti-tumor activity across multiple HER2-expressing cancers."
Zanidatamab is a bispecific antibody developed on Zymeworks' Azymetric platform to bind two non-overlapping epitopes of HER2. Zymeworks is advancing the drug in multiple clinical trials as a treatment for solid tumors expressing HER2, including HERIZON-BTC-01 and HERIZON-GEA-01. In the latter Phase III study, researchers are studying zanidatamab with chemotherapy plus or minus tislelizumab in patients with HER2-expressing unresectable, locally advanced, or metastatic gastroesophageal adenocarcinoma.
In a conference call Monday, Zymeworks CEO Ken Galbraith said the company is planning to meet next year with regulatory agencies about the zanidatamab development program and discuss next steps.