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Zion Pharma Begins Phase I Study of ZN-A-1041 in HER2-Positive Solid Tumors, Breast Cancer

NEW YORK – China's Zion Pharma on Tuesday said that it had dosed the first patient in the US with its investigational HER2-targeting drug, ZN-A-1041. The agent is designed to cross the blood-brain barrier, ultimately treating brain metastases in patients with advanced breast cancer.

The US clinical trial, which is taking place at the Dana-Farber Cancer Institute and the Duke Cancer Institute, among other sites, includes multiple sub-phases. Phase Ia will assess the safety and tolerability of ZN-A-1041 as a monotherapy in patients with HER2-positive advanced solid tumors, including those with brain metastases. Phase Ib will evaluate the safety and tolerability of ZN-A-1041 in combination with chemotherapy in patients with advanced HER2-positive breast cancer, including those with brain metastases, and Phase Ic will investigate the same combination, but specifically in patients with brain metastases.

Beyond the safety, tolerability, and maximum tolerated dose of the agent, the clinical trial will also assess secondary endpoints including patients' plasma levels, as well as preliminary rates of overall response and progression-free survival. The trial will screen patients for HER2 expression using immunohistochemistry and fluorescence in situ hybridization.

Zion CEO and Cofounder Zack Cheng said in a statement that the company recently raised $20 million in a Series A follow-on financing round that will sufficiently fund the company for the next two years. Zion has also appointed a new Chief Medical Officer, Wendy Li, who has previously worked in oncology clinical development at companies such as Genentech, Sanofi, and Pfizer.