The decision was based on positive results from the HERIZON-BTC-01 trial in previously treated HER2-amplified biliary tract cancers
Zanidatamab is based on Zymeworks’ Azymetric platform, which enables the simultaneous binding of two non-overlapping epitopes of HER2. (Credit: National Cancer Institute on Unsplash)
Ireland-based Jazz Pharmaceuticals has exercised its option to continue with its exclusive rights to Zymeworks’ cancer drug candidate zanidatamab for a one-time payment of $325m.
Under the terms of the agreement, the one-time payment will be made by Jazz Pharmaceuticals in Q4 2022 to continue with its exclusive license to develop and commercialise zanidatamab in the US, Europe, and the Japanese markets. It excludes certain Asia-Pacific territories where Zymeworks has previously licensed the drug candidate to BeiGene.
Zanidatamab is an investigational bispecific antibody, based on Zymeworks’ Azymetric platform. The drug candidate is being developed as a targeted treatment option for patients with solid tumours that express HER2.
Jazz Pharmaceuticals signed the initial license and collaboration agreement with Zymeworks in October 2022. The former previously made a separate upfront payment of $50m.
For a total of up to $1.76bn in possible payments, Zymeworks is eligible to receive up to $525m upon meeting specific regulatory milestones and up to $862.5m in potential commercial milestone payments.
Additionally, Zymeworks is entitled to collect tier-based royalties ranging from 10% to 20% on Jazz Pharmaceuticals’ net sales, subject to the approval of zanidatamab.
Jazz Pharmaceuticals research and development global head and EVP Rob Iannone said: “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.
“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-tumour activity across multiple HER2-expressing cancers.”
Jazz Pharmaceuticals said that the decision to take the option for zanidatamab was backed by positive results from the HERIZON-BTC-01 trial in previously treated HER2-amplified biliary tract cancers (BTC).
The trial showed that 41.3% of enrolled participants with HER2-amplified and expressing disease registered an objective response as evaluated by an independent central review. The median duration was noted to be 12.9 months and the safety profile of zanidatamab was similar to previously reported monotherapy studies.