BioPharma, Pharma

Roche Forks Over $70M for Brain-Penetrating Cancer Drug Candidate

Roche is acquiring global rights to a Zion Pharma Limited drug candidate with potential applications treating breast cancer that has metastasized to the brain. The small molecule, currently in Phase 1 testing, is designed to penetrate the blood-brain barrier.

When breast cancer spreads, one of the places it’s likely to go is the brain. Roche is adding to its cancer drug pipeline by acquiring an early-stage compound with the potential to address cancer in the brain.

Roche has agreed to pay $70 million for global rights to ZN-A-1041, the lead program of Chinese biotech company Zion Pharma Limited. According to terms of the agreement announced Tuesday, the sum consists of an upfront payment and pending near-term milestone payments. Zion could receive up to $610 million more depending on the achievement of development, regulatory, and sales milestones.

Zion’s ZN-A-1041 is a small molecule designed to selectively block tyrosine kinase, an enzyme that targets human epidermal growth factor receptor 2 (HER2), a cancer-driving protein abundant on the surface of cancer cells. Roche already has a franchise of HER2-targeting therapies including the antibody drugs Herceptin, Perjeta, and Kadcyla. But the Zion small molecule’s capability to penetrate the blood-brain barrier gives the Swiss pharmaceutical giant a drug prospect with the potential to treat or prevent the spread of cancer to the brain in patients with HER2-positive metastatic breast cancer. According to Roche, up to 50% of patients with HER2-positive metastatic brain cancer will develop brain metastasis in the course of the disease.

In the hands of Zion, ZN-A-1041, a twice-daily capsule, has reached Phase 1 testing in the U.S. and China. The studies, enrolling patients with advanced HER2-positive solid tumors, are evaluating the Zion compound in combination with current standard of care drugs for advanced breast cancer. Preclinical and early clinical data are set to be presented next month during the annual meeting of the American Society of Clinical Oncology. Going forward, Roche will be responsible for developing and manufacturing ZN-A-1041. If the molecule reaches the market, Roche will handle commercialization, paying Zion royalties from sales.

“Within five years, we have gone from company formation to first-in-human, to finding a partner in Roche, who has the resources and expertise to bring ZN-A-1041 to patients with few other therapeutic options,” Zion Chairman, CEO and co-founder Zack Cheng said in a prepared statement.

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