Medivation, Inc. and NanoString Technologies, Inc., have announced they have entered into a collaboration, together with Astellas Pharma Inc., to pursue the translation of a novel gene expression signature algorithm from Medivation into a companion diagnostic assay using NanoString's nCounter® Dx Analysis System. Under the terms of the collaboration agreement, NanoString will be responsible for developing and validating the diagnostic test and, if the parties thereafter determine to proceed, NanoString would also be responsible for seeking regulatory approval for and commercializing the diagnostic test. NanoString is eligible to receive up to $22 million for technology access, near-term milestones and development funding, in addition to other potential undisclosed downstream payments.
Under the Collaboration Agreement, NanoString will modify its PAM50-based Prosigna® Breast Cancer Assay for potential use as a companion diagnostic test for enzalutamide for triple negative breast cancer. The modified test will be based upon data from a Phase 2 trial conducted by Medivation and Astellas that evaluated enzalutamide in patients with triple negative breast cancer.
"We are excited about the partnership with NanoString given their expertise in diagnostic development and that the Prosigna assay has regulatory clearance in the U.S. and European Union," said Amy Peterson, M.D., vice president, clinical development at Medivation. "Triple negative breast cancer has no recognized target and standard therapy is therefore cytotoxic chemotherapy. 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 excited to work with Medivation and Astellas to translate their discoveries and Phase 2 findings into a potential label expansion for enzalutamide with a companion diagnostic," said Brad Gray, president and chief executive officer of NanoString Technologies. "We're also 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. 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."
XTANDI® (enzalutamide) capsules is currently approved for the treatment of metastatic castration-resistant prostate cancer; it is not approved for use in women and is contraindicated in women who may become pregnant. Enzalutamide is not approved for women with advanced triple negative breast cancer. See Important Safety Information below.