China-based Zion Pharma Ltd, a biotechnology company specializing in the development of brain-penetrable compounds, has announced that Roche (SWX: ROG) has acquired the global rights to Zion’s lead program, ZN-A-1041. This orally administered selective tyrosine kinase inhibitor (TKI) targets the human epidermal growth factor receptor 2 (HER2) and is designed to be blood-brain-barrier-penetrant, offering potential in treating or preventing brain metastases in patients with HER2-positive metastatic breast cancer, a condition that affects up to 50% of patients during the course of their disease.
Global Development and Commercialization Agreement
Under the terms of the agreement, Roche will assume responsibility for the further development, manufacturing, and commercialization of ZN-A-1041 globally after a transition period. Zion will receive up to USD 70 million in upfront and near-term milestone payments, with the potential for an additional USD 610 million in development, regulatory, and sales-based milestone payouts, as well as tiered royalties on future sales.
Zion’s Chairman and CEO, Dr. Zack Cheng, on the Partnership
Dr. Zack Cheng, Chairman, CEO, and co-founder of Zion, highlighted the significance of ZN-A-1041 as a “potentially best-in-class therapy for patients with HER2-positive breast cancer, particularly in the field of brain metastasis due to the high blood-brain barrier permeability of this asset.” He continued, “Within five years, we have progressed from company formation to first-in-human trials, to securing a partnership with Roche, who possesses the resources and expertise to bring ZN-A-1041 to patients with limited therapeutic options.”
Roche’s Global Pharma Partnering Head James Sabry on the Collaboration
James Sabry, Roche’s global pharma partnering head, noted that the partnership with Zion “builds on Roche’s legacy and expertise in the treatment of HER2-positive breast cancer and supports our pursuit of advancing science by combining external innovation with our in-house capabilities to address areas of high unmet patient needs.”
Ongoing Phase I Trial for ZN-A-1041
ZN-A-1041 is currently undergoing a Phase I trial at multiple sites in the US and China. Additional details of the trial will be presented at the poster sessions during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2023.-Fineline Info & Tech
