Jazz Pharmaceuticals exercised its option on Zymeworks’ promising anti-cancer agent.
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Jazz Pharmaceuticals exercised an exclusive development option with Zymeworks for the company’s promising anti-cancer agent zanidatamab. This option exercise makes Zymeworks eligible for a $325 million payday.
On Monday, Zymeworks reported data from the Phase IIb HERIZON-BTC-01 trial that showed zanidatamab as monotherapy generated a confirmed objective response rate of 41.3% in patients with previously treated HER2-amplified and expressing biliary tract cancers.
Additionally, the data showed a 12.9-month median duration of response in those patients.
The antibody’s safety profile remained consistent with previous studies, Zymeworks noted.
Rob Iannone, global head of research and development at Jazz called the Zymeworks data “compelling”. The data strengthen Jazz’s confidence in the potential of the antibody in cancers where there is a 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,” Iannone said in a brief statement.
Zanidatamab is an investigational bispecific antibody developed with Zymeworks’ Azymetric platform. The antibody is designed to simultaneously bind two non-overlapping epitopes of HER2.
It is estimated that 5% to 19% of biliary tract cancer patients have tumors that express HER2. Currently, there are no HER2-targeted therapies approved for the treatment of biliary tract cancer.
Zanidatamab builds on an expanding oncology pipeline at Jazz that also includes JZP898, an engineered IFN⍺2b cytokine pro-drug licensed from Werewolf Therapeutics. The company’s pipeline also includes Zepzelca (lurbinectedin), which has been approved for the treatment of small cell lung cancer.
For Zymeworks, Jazz’s decision is a lucrative one. The company will now receive a $325 million infusion of cash. In all, Zymeworks stands to gain a total of $1.76 billion in various regulatory and commercial milestones.
In October, Jazz struck a $50 million licensing agreement for zanidatamab. If Jazz exercised its development options, the additional milestone payments would kick in. The licensing agreement gave the company commercialization rights in the U.S., Europe and Japan for zanidatamab.
Zymeworks Chief Executive Officer Kenneth Galbraith called Jazz the ideal partner for zanidatamab. In a brief statement, he pointed to the company’s “track record of R&D and commercial success.”
Galbraith told BioSpace the financing will enable Zymeworks to focus on the growth of its early-stage pipeline. He added that the company has a goal of advancing five new programs into the clinic over the next five years.
Jazz isn’t the only company interested in zanidatamab. China’s BeiGene forged a zanidatamab-related collaboration in 2018. BeiGene has commercial rights to the antibody in most of Asia, excluding Japan, as well as Australia and New Zealand.
In December 2021, BeiGene dosed the first patient in the HERIZON-GEA-01 study. The trial is evaluating zanidatamab in combination with chemotherapy and with or without the checkpoint inhibitor tislelizumab as a first-line treatment for metastatic HER2-positive gastroesophageal adenocarcinomas.
Given the data from the Phase IIb HERIZON-BTC-01, as well as the BeiGene-partnered program, Galbraith said Zymeworks is excited about zanidatamab’s “breadth of effectiveness across HER2-expressing cancers.”
He maintains the antibody has potential across multiple cancer indications as both a monotherapy and in combination with other drugs.
“While we continue to generate data in breast cancer and colorectal cancer, the path forward will be determined by Jazz and BeiGene as they look to maximize the value of zanidatamab across HER2-expressing cancers,” Galbraith said.
