Zymeworks Inc. (NASDAQ: ZYME), a Canadian biotech company, in partnership with BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has submitted a Biologics License Application (BLA) to Chinese regulators for zanidatamab, a bispecific antibody for the treatment of HER2-positive biliary tract cancer (BTC) as a second-line therapy. Zymeworks’ zanidatamab is designed to bind two distinct epitopes of the HER2 receptor, potentially offering a new treatment option for patients with this condition.
The BLA is supported by data from the Phase IIb HERIZON-BTC-01 clinical trial (NCT04466891, CTR20202607), which demonstrated that zanidatamab can elicit clinically meaningful and durable responses in patients with previously treated HER2-positive BTC. The trial reported an objective response rate (ORR) of 41.3%, a median duration of response (DOR) of 12.9 months, and a median progression-free survival (PFS) of 5.5 months.
BeiGene secured development and commercialization rights for Zymeworks’ zanidatamab in a deal signed in 2018, with an initial payment of $53 million. The filing of the BLA in China is set to trigger an $8 million milestone payment from BeiGene to Zymeworks, with up to $164 million in additional potential milestone payments. BeiGene is also committed to paying 19.5% of the revenues generated from the Asia-Pacific region, where the drug is being developed.
In a separate development, a BLA has also been submitted to the US FDA for zanidatamab, with a Prescription Drug User Fee Act (PDUFA) date set for November 2024. The FDA has granted the drug Breakthrough Therapy designation for patients with previously treated HER2 gene-amplified BTC, and two Fast-Track designations: one as a monotherapy for refractory BTC and another in combination with chemotherapy for first-line gastroesophageal adenocarcinoma (GEA).- Fineline.com
