Zymeworks Inc. (NASDAQ: ZYME), a Canada-based biotech company, has announced in its Q3 financial report that the licensing agreement with China’s BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) for the antibody drug conjugate (ADC) zanidatamab zovodotin (ZW49) has been cancelled. This development affects the HER2-targeted ADC that BeiGene had in-licensed alongside ZW25 (zanidatamab) in a deal inked in July 2018.
Financial and Licensing Background
BeiGene had paid an upfront fee of USD 40 million for development and commercial rights in Asia (excluding Japan), Australia, and New Zealand as part of the 2018 agreement. The cancellation of the agreement comes after zanidatamab zovodotin showed relatively weak data in a Phase I trial last year, with a confirmed objective response rate of 31% and a disease control rate of 72% in HER2-expressing solid tumors.
Ongoing Development of ZW25
Despite the cancellation of the ZW49 agreement and with no formal notification from BeiGene, it is assumed that the development of zanidatamab (ZW25) continues. BeiGene recently presented promising data for ZW25 in combination with chemotherapy and anti-PD-1 antibody tislelizumab as a first-line treatment for HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJC). This regimen demonstrated strong results, including an objective response rate (ORR) of 75.8%, a median duration of response (mDOR) of 22.8 months, and a median progression-free survival (PFS) of 16.7 months.
Phase III Trial and Future Expectations
A Phase III trial (NCT05152147) for the ZW25 regimen has already been initiated, with top-line data expected to be reported in 2024. This ongoing trial and the anticipated results highlight the continued interest and investment in the development of ZW25, despite the setback with ZW49.-Fineline Info & Tech
