CAMBRIDGE, Mass.–(BUSINESS WIRE)–Today, Foundation Medicine, Inc., a pioneer in cancer molecular profiling, announced a collaboration with Arvinas, Inc., to develop FoundationOne®Liquid CDx as a companion diagnostic for use with bavdegalutamide (ARV-110) from Arvinas, a new experimental PROTAC® protein degrader targeting the androgen receptor (AR). Arvinas’ bavdegalutamide is being developed for the potential treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have progressed with existing therapies.
Arvinas is a clinical-stage biotechnology company and a pioneer in the growing field of targeted protein degradation. Arvinas’ proprietary PROTAC® Targeted Protein Degraders, or Proteolysis Targeting Chimeras, work by harnessing the body’s natural protein removal system to selectively and efficiently degrade and remove pathogenic proteins. AR activity is a key driver of prostate cancer, making the ability to regulate AR signaling an important factor in controlling disease progression.
“We look forward to collaborating with Foundation Medicine to develop a companion diagnostic aimed at improving patient access,” said Ron Peck, MD, chief medical officer at Arvinas. “Foundation Medicine’s deep understanding of cancer genomics, scalable solutions and regulatory expertise make it an ideal partner for us as we develop bavdegalutamide as a potential new treatment for men with prostate cancer. prostate.
Foundation Medicine’s comprehensive FDA-cleared genomic profiling test portfolio provides physicians with blood and tissue testing options to detect genomic alterations that help guide personalized treatment decisions. As companion diagnostics, FoundationOne®CDx and FoundationOne®Liquid CDx allow oncologists to identify patients who may be suitable for FDA-approved targeted therapies.
“We are proud to serve as an end-to-end partner for Arvinas as they pioneer this new approach to treating cancer,” said Sanket Agrawal, Director of Biopharmaceutical Affairs, Foundation Medicine. “Bringing our capabilities to this emerging area of biotechnology puts us on an exciting path to deepen our collective understanding of cancer biology and bring more innovative treatment options to patients now and in the future.”
Foundation Medicine is an essential partner for biopharmaceutical organizations navigating the complexity of cancer care and research. This latest collaboration adds to its more than 65 global biopharmaceutical and biotechnology partnerships aimed at bringing targeted cancer treatments to patients faster.
FoundationOne CDx is a next-generation sequencing-based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and gene rearrangements. selected genes, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational load (TMB) using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue samples (FFPE). FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling for use by qualified healthcare professionals in accordance with professional oncology guidelines for patients with solid malignant neoplasms. Use of the test does not guarantee that a patient will be matched to a treatment. A negative result does not exclude the presence of an alteration. Some patients may require a biopsy. For a complete list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.
About FoundationOne®Liquid CDx
FoundationOne Liquid CDx is a next-generation sequencing-based qualitative in vitro diagnostic test for prescription use only that uses high-throughput hybridization-based targeted capture technology to analyze 324 genes using cell-free DNA (cfDNA) isolated from plasma derived from peripherally anticoagulated whole blood of patients with advanced cancer. The test is FDA-cleared to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of Intended Use) in accordance to the labeling of the approved therapeutic product. Additional genomic results may be reported and are not prescriptive or conclusive for the labeled use of a specific therapeutic product. Use of the test does not guarantee that a patient will be matched to a treatment. A negative result does not exclude the presence of an alteration. Patients negative for associated diagnostic mutations should be referred for tumor tissue testing and genomic alteration status confirmed using an FDA-cleared tumor tissue test, if possible. For the full label, including associated diagnostic indications and complete hazard information, please visit www.F1LCDxLabel.com.
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular cancer profiling, working to shape the future of clinical care and research. We collaborate with a wide range of partners in the cancer community and strive to set the standard for quality, scientific excellence and regulatory leadership. Our deep understanding of cancer biology helps doctors make informed treatment decisions for their patients and enables researchers to develop new drugs. Every day, we are committed to helping our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, visit us at www.FoundationMedicine.com and follow us on Twitter and LinkedIn.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
Source: Foundation Medicine