On December 21, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Zymeworks Inc. (Nasdaq: ZYME) reported that Jazz has exercised its option to continue with its exclusive development and commercialization rights to Zymeworks’ zanidatamab in key markets, including the U.S., Europe and Japan, pursuant to the license and collaboration agreement entered into in October 2022 (Press release, Jazz Pharmaceuticals, DEC 21, 2022, View Source [SID1234625489]).
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The decision to exercise this option follows positive top-line clinical data from HERIZON-BTC-01, a pivotal trial in previously treated HER2-amplified biliary tract cancers (BTC), which demonstrated that 41.3% (95% CI: 30.4, 52.8) of enrolled patients with HER2-amplified and expressing (IHC2+ and 3+) disease achieved an objective response as assessed by independent central review. The median duration of response was 12.9 months (95% CI: 5.95 to not reached). The safety profile of zanidatamab in this trial was consistent with that observed in previously reported monotherapy studies, with no new safety signals identified.
"The compelling top-line clinical data from the pivotal trial in patients with BTC highlight zanidatamab’s potential to transform the current standard of care," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "This important milestone strengthens our confidence in advancing this therapy for cancer patients with significant unmet need. While our initial focus will be on the ongoing clinical programs in BTC and GEA, these data add to the growing body of evidence that zanidatamab has anti-tumor activity across multiple HER2-expressing cancers."
"We’re pleased that our collaboration with Jazz is moving forward, enabling the global, rapid advancement of zanidatamab in multiple tumor types with the potential to provide a foundational HER2-targeted therapy for patients with difficult-to-treat cancers and limited treatment options," said Kenneth Galbraith, Chair & CEO of Zymeworks. "Jazz’s track record of R&D and commercial success, combined with their deep relationships in the oncology community and shared passion for working to improve outcomes for cancer patients, make them the ideal development and commercialization partner for zanidatamab."
Transaction Terms
Pursuant to the terms of the agreement, Jazz will make a one-time payment of $325 million to Zymeworks, in the fourth quarter of 2022, to exercise its option to continue with its exclusive license 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. Jazz previously made a separate $50 million up-front payment. 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. Pending approval of zanidatamab, Zymeworks is eligible to receive tiered royalties between 10% and 20% on Jazz’s net sales.
MTS Health Partners, L.P. acted as exclusive financial advisor and Wilson Sonsini Goodrich & Rosati P.C. acted as legal advisor to Zymeworks in connection with the license and collaboration agreement entered into in October 2022.
About Zanidatamab
Zanidatamab is an investigational 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, along with collaborators Jazz and BeiGene, are 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.
About Biliary Tract Cancers
Biliary tract cancers (BTC), including gallbladder cancer and cholangiocarcinoma, account for approximately 3% of all adult cancers and are often associated with a poor prognosis1. Globally, more than 210,000 people are diagnosed with BTC every year2 and most patients (> 65%) are diagnosed with tumors that cannot be removed surgically. The human epidermal growth factor receptor 2 (HER2) is a well-validated target for anti-cancer therapy. About 5% to 19% of patients with BTC have tumors that express HER23 and may be positioned for potential benefit from HER2-targeted therapy. Currently no HER2-targeted therapy has been approved for the treatment of BTC.
About Gastroesophageal Adenocarcinoma
Gastroesophageal adenocarcinoma (GEA) is the fifth most common cancer worldwide and approximately 20% of patients are HER2–positive. HER2–positive GEA has high morbidity and mortality, and patients are urgently in need of new treatment options.