Date: 2016-01-07
Type of information: Collaboration agreement
Compound: companion diagnostic test for enzalutamide
Company: Medivation (USA - CA) NanoString Technologie (USA - WA)
Therapeutic area: Cancer - Oncology
Type agreement: collaboration
Action mechanism: companion diagnostic. The Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient's risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma. The Prosigna Assay requires minimal hands-on time and runs on NanoString's proprietary nCounter® Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision. In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as: (1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.
Disease: triple negative breast cancer
Details: * On January 7, 2016, Medivation and NanoString Technologies announced they have entered into a collaboration, together with Astellas Pharma, 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. 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. 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.
Financial terms: 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.
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