On October 19 2022, Zymeworks BC Inc. and Jazz Pharmaceuticals Ireland Ltd. announced that they entered into an exclusive license agreement to develop and commercialize zanidatamab. Under that arrangement, Jazz will receive an exclusive license from Zymeworks to develop and commercialize zanidatamab in the United States, Europe, Japan, and all other territories except for those Asia/Pacific territories that Zymeworks previously licensed to BeiGene, Ltd.
Zymeworks is eligible to receive a $50 million upfront payment, following receipt of the clearance under the United States Hart-Scott Rodino Antitrust Improvements Act of 1976, and should Jazz decide to continue the collaboration following readout of the top-line clinical data from Zymeworks’ ongoing clinical trial in biliary tract cancer (BTC), a second, one-time payment of $325 million. Zymeworks is also eligible to receive up to $525 million upon the achievement of certain regulatory milestones and up to $862.5 million in potential commercial milestone payments, for total potential payments of up to $1.76 billion, in addition to double digit royalties. The transaction is expected to close within the 2022 calendar year.
Zanidatamab 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 leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The U.S. Federal and Drug Administration has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy, for first-line gastroesophageal adenocarcinoma (GEA).
The Wilson Sonsini team that advised Zymeworks on the transaction included:
Technology and Transactions
Farah Gerdes
Amy Foust
Morgan Brown
Christina Fuleihan
Corporate
Bryan King
Laura Duncan
Jason Oh
Patents and Innovation
Matt Wheeler
Privacy and Cybersecurity
Haley Bavasi
Nikolaos Theodorakis
For more information, please see Zymeworks' news release. Further coverage can be found on Biospace and Fierce Biotech.