Initial Goal of Collaboration is to Develop FoundationOne®Liquid CDx as a Companion Diagnostic for Bavdegalutamide (ARV-110), Arvinas’ Investigational Androgen Receptor-Targeting PROTAC® Protein Degrader
CAMBRIDGE, Mass., June 05, 2022--(BUSINESS WIRE)--Today Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, announced a collaboration with Arvinas, Inc., to develop FoundationOne®Liquid CDx as a companion diagnostic for use with Arvinas’ bavdegalutamide (ARV-110), an investigational novel 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 on existing therapies.
Arvinas is a clinical-stage biotechnology company and a pioneer in the rapidly growing field of targeted protein degradation. Arvinas’ proprietary PROTAC® targeted protein degraders, or proteolysis-targeting chimeras, work by harnessing the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. AR activity is a key driver of prostate cancer, which makes 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, M.D., chief medical officer at Arvinas. "Foundation Medicine’s deep understanding of cancer genomics, scalable solutions, and regulatory expertise makes them an ideal partner for us as we develop bavdegalutamide as a potential new therapy for men with prostate cancer."
Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offer physicians both blood- and tissue-based testing options for detecting 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 appropriate 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 treat cancer," said Sanket Agrawal, chief biopharma business officer, Foundation Medicine. "Bringing our capabilities to this emerging area of biotechnology sets us on an exciting path to deepen our collective understanding of cancer biology and deliver more novel treatment options to patients now and in the future."
Foundation Medicine is an essential partner for biopharma organizations navigating the complexity of cancer care and research. This latest collaboration adds to its more than 65 global biopharma and biotechnology partnerships aimed at getting targeted cancer treatments to patients faster.
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. 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 to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full 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 qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved 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 the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
Source: Foundation Medicine
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Erin Smith, 262-914-2779