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NanoString to Develop Companion Dx for Medivation, Astellas Breast Cancer Drug

NEW YORK (GenomeWeb) – NanoString Technologies has signed a deal with Medivation and Astellas Pharma to develop a companion diagnostic for the biopharmaceutical companies' investigational breast cancer drug enzalutamide.

Enzalutamide is an antiandrogen developed by Medivation and Astellas and approved for the treatment of metastatic castration-resistant prostate cancer in 2012 under the name Xtandi. The drug has also shown promise in triple-negative breast cancer patients. 

Under the terms of the agreement, NanoString will modify its Prosigna Breast Cancer Assay, which runs on the company's nCounter platform and provides a disease-recurrence score based on the PAM50 gene signature, as a companion test for enzalutamide based on the results of a recently completed Phase II trial of the drug in triple-negative breast cancer.

NanoString will be responsible for developing and validating the test, seeking regulatory approval, and commercializing the product. In exchange, the company is eligible to receive up to $22 million in technology-access fees, near-term milestones, and development funding, plus potential undisclosed downstream payments.

"Triple-negative breast cancer has no recognized target and standard therapy is therefore cytotoxic chemotherapy," Amy Peterson, vice president of clinical development at Medivation, said in a statement. "This diagnostic has the potential to identify patients with triple-negative breast cancer appropriate for treatment with enzalutamide. We look forward to generating additional clinical data that validates this potential in a severely underserved patient population."

"We're … pleased to have the opportunity to leverage our PAM50-based Prosigna breast cancer franchise, potentially expanding its role in informing breast cancer treatment decisions and enhancing the description of the intrinsic biology of breast cancer to aid in therapeutic treatment decisions," NanoString President and CEO Brad Gray added. "Furthermore, we believe this collaboration will provide additional validation of our nCounter Dx Analysis System as the platform-of-choice for development of multiplexed companion diagnostic assays."