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Vera Grossmann, Managing Director, Foundation MedicineWith the help of some of the latest innovations in next-generation sequencing (NGS), revealing DNA mutations in tumours has opened many avenues to explore the vast mysteries of a carcinogenic genome in the human body. Fortunately for patients facing advanced cancer, Foundation Medicine, an acclaimed biotechnology company, is changing the narrative by helping healthcare professionals provide more tailored treatment options for affected patients.
Founded in 2010 in Cambridge, MA, Foundation Medicine is a molecular insights company dedicated to revolutionising cancer care with a deep understanding of genomic changes that contribute to each patient’s unique cancer. The company focuses on designing, developing, and conducting comprehensive genomic profiling (CGP) tests. The powerful insights gained from CGP allow for Foundation Medicine’s highly-qualified staff to innovate on personalised healthcare options for the future, while supporting professionals in advocating a tailored care plan for each patient. “It is our mission to generate better molecular insights and increase accessibility for all to such technology,” expresses Vera Grossmann, Managing Director of Foundation Medicine GmbH based in Germany.
As a member of the Roche Group, a global leader in personalised healthcare, Foundation Medicine works with Roche on solutions to create an ecosystem of fully-personalised medicine and targeted therapy in oncology. “The goal is nothing less than to transform cancer care” states Josh Jordan, Lifecycle Leader for Foundation Medicine at Roche.
“Precision medicine, for us, is a reality,” adds Marlene Thomas, Global Lead for Integrated Molecular Medicine at Roche. Marlene and her team are leading the ex-US research program of Roche and Foundation Medicine focusing on evidence-based medicine to support molecular guided therapy options for rare and uncommon cancers and cancers with a high unmet medical need. For example, the global CUPISCO study utilises Foundation Medicine services and compares the efficacy and safety of targeted therapy or cancer immunotherapy versus platinum-based chemotherapy in patients with Cancer of Unknown Primary Site (CUP).
Marlene Thomas, Global Lead for Integrated Molecular Medicine and Josh Jordan, Lifecycle Leader, Foundation MedicineFoundation Medicine, headquartered in Boston, has come a long way in the decade since its inception in this ever-advancing field of biotechnology. Today, the company employs nearly 1,600 employees, and partners with healthcare organisations and physicians all over the globe. Foundation Medicine has processed over 200,000 patient samples globally this year alone. “Further, we are constantly collaborating with our global partners for instance in Switzerland, China, Israel, Austria, and France to improve precision medicine, all the while supporting local labs as well,” expresses Vera. The company’s FoundationCore genomic database houses the de-identified molecular profiles of over 450,000 patients in a structured manner to help accelerate the development of new, genomically-driven therapies. Additionally, Roche and Foundation Medicine collaborate with experts across the healthcare sector—physicians, patients, health systems— to advance the acceptance and implementation of molecular profiling. “It is not easy to embed CGP into clinical practice, but patients deserve it to be the standard for advanced patient care and that is what our company is working towards,” adds Josh.
Precision medicine is our reality
With such comprehensive and scientific knowledge about ongoing cancer research and therapy, Foundation Medicine, in collaboration with Roche, is set to create waves of change and better the lives of millions throughout the world. Moving forward, the company hopes to increase clinical adoption of CGP internationally at affordable costs, while equipping local labs and research teams with high quality and clinically validated oncology testing products.
Company
Foundation Medicine
Management
Vera Grossmann, Managing Director, Marlene Thomas, Global Lead for Integrated Molecular Medicine and Josh Jordan, Lifecycle Leader, Foundation Medicine
Description
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer
Foundation Medicine News
Foundation Medicine and Natera Announce Broad Clinical Launch and Medicare Coverage of FoundationOne®Tracker
Foundation Medicine and PMV Pharma Announce Collaboration to Develop Companion Diagnostic for Rezatapopt, a First-In-Class, Investigational, Selective p53 Y220C Reactivator
BOSTON & PRINCETON - Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP; “PMV Pharma”) today announced a partnership to develop Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne®CDx, as a companion diagnostic for PMV Pharma’s rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation.
Across all human cancers, TP53 is the most frequently altered gene, with mutations occurring in approximately 50% of cancer cases.1 Historically, TP53 mutations have been considered undruggable despite its prevalence across cancers.2 TP53 Y220C mutation is one of the most frequently observed TP53 mutations, occurring in approximately 1% of all solid tumors.3 PMV Pharma is developing rezatapopt, a small molecule, to reactivate the p53 function in an advanced cancer patient population harboring a TP53 Y220C mutation.
“The innovative science driven by PMV Pharma’s efforts specific to TP53 Y220C has the potential to offer a new therapeutic option for patients in this area of high unmet medical need,” said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. “We’re proud to provide our high-quality tissue-based genomic test, along with real-world data from our Flatiron Health-Foundation Medicine Clinico-Genomic Database, to support PMV Pharma as they develop this exciting new treatment option.”
Rezatapopt (PC14586) is an investigational, first-in-class, selective p53 reactivator designed to stabilize p53 Y220C proteins. The TP53 Y220C mutation creates a small pocket in the p53 protein, making it thermally unstable and unable to effectively interact with DNA. Rezatapopt is an orally available small molecule designed to selectively bind to a pocket in the p53 Y220C protein, leading to the restoration of the wild-type p53 tumor suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation, and is the subject of the ongoing registrational, tumor-agnostic PYNNACLE Phase 2 clinical trial. For more information about the Phase 2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).
Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. If the CDx and separately the therapy are approved, FoundationOne CDx would be the first companion diagnostic to identify patients with TP53 Y220C mutations who may be eligible for rezatapopt.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
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 LinkedIn and X.
Across all human cancers, TP53 is the most frequently altered gene, with mutations occurring in approximately 50% of cancer cases.1 Historically, TP53 mutations have been considered undruggable despite its prevalence across cancers.2 TP53 Y220C mutation is one of the most frequently observed TP53 mutations, occurring in approximately 1% of all solid tumors.3 PMV Pharma is developing rezatapopt, a small molecule, to reactivate the p53 function in an advanced cancer patient population harboring a TP53 Y220C mutation.
“The innovative science driven by PMV Pharma’s efforts specific to TP53 Y220C has the potential to offer a new therapeutic option for patients in this area of high unmet medical need,” said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. “We’re proud to provide our high-quality tissue-based genomic test, along with real-world data from our Flatiron Health-Foundation Medicine Clinico-Genomic Database, to support PMV Pharma as they develop this exciting new treatment option.”
Rezatapopt (PC14586) is an investigational, first-in-class, selective p53 reactivator designed to stabilize p53 Y220C proteins. The TP53 Y220C mutation creates a small pocket in the p53 protein, making it thermally unstable and unable to effectively interact with DNA. Rezatapopt is an orally available small molecule designed to selectively bind to a pocket in the p53 Y220C protein, leading to the restoration of the wild-type p53 tumor suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation, and is the subject of the ongoing registrational, tumor-agnostic PYNNACLE Phase 2 clinical trial. For more information about the Phase 2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).
Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. If the CDx and separately the therapy are approved, FoundationOne CDx would be the first companion diagnostic to identify patients with TP53 Y220C mutations who may be eligible for rezatapopt.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
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 LinkedIn and X.
Several recent publications demonstrate clinical validity of ctDNA monitoring using FoundationOne®Tracker
CAMBRIDGE - Foundation Medicine, Inc., announced the broad clinical launch of FoundationOne®Tracker, a personalized tissue-informed circulating tumor DNA (ctDNA) test to monitor cancer patients’ response to therapy. FoundationOne Tracker is now available to all U.S. healthcare providers for treatment response monitoring (TRM).
In addition, the Palmetto GBA Molecular Diagnostics Program (MolDX) of the Centers for Medicare & Medicaid Services (CMS) has made the determination, effective June 17, 2023, that FoundationOne Tracker is eligible for coverage when monitoring the response to immune-checkpoint inhibitor (ICI) therapy in qualifying Medicare beneficiaries with all solid tumors. It's worth noting that FoundationOne Tracker has also received approval from the Clinical Laboratory Evaluation Program (CLEP) of New York, which is the sole U.S. state requiring an independent regulatory review process for laboratory developed tests.
FoundationOne Tracker is a ctDNA monitoring test informed by tissue, designed for patients with advanced cancer spanning all solid tumors. This test leverages genomic data obtained from FoundationOne®CDx, a comprehensive genomic profiling test from Foundation Medicine that uses personalized assay design and ctDNA analysis from Natera. FoundationOne Tracker is conducted serially to track patients' responses to therapy, aiding physicians in identifying individuals who are resistant to current treatment and might require alternative therapy, as well as those who are responding positively to therapy and could potentially benefit from dose reduction or therapy discontinuation.
While imaging methods such as CT scans and MRIs are the conventional standard for monitoring cancer patients' responses to treatment, they have well-known limitations that depend on the cancer type and the prescribed treatment. When used in conjunction with imaging, tissue-informed ctDNA monitoring with FoundationOne Tracker can offer greater confidence compared to relying solely on imaging methods.
“Tissue-informed ctDNA monitoring is a natural extension of Foundation Medicine’s current genomic testing portfolio, and we believe this new offering will further enable oncologists to make the best possible decisions about their patients’ care through actionable and personalized data,” said Foundation Medicine’s Chief Executive Officer, Brian Alexander, M.D. “The insights provided by FoundationOne Tracker, along with Medicare coverage of the test for patients undergoing immunotherapy, position us to broaden the impact of genomic profiling and bring personalized cancer care to more patients.”
“This is a big win for patients,” said Natera’s Chief Executive Officer, Steve Chapman. “Our partnership with Foundation Medicine, together with the recent Medicare coverage decision, enables even greater access to Natera's core technology for personalized immunotherapy monitoring.”
Numerous recent publications provide compelling evidence of the clinical validity of FoundationOne Tracker in late-stage monitoring. A study presented at this year's American Society of Clinical Oncology (ASCO) annual meeting and recently published in Clinical Cancer Research revealed that FoundationOne Tracker can offer valuable insights into the outcomes of maintenance immunotherapy for patients with advanced non-small cell lung cancer, based on data from the IMpower131 trial.
Additionally, research published in Molecular Oncology showcases findings from the OMICO-MoST study. This research indicates that as early as four weeks after treatment initiation, a reduction in ctDNA levels is a predictive indicator of improved overall survival. Notably, in two patients who achieved a complete response, the clearance of ctDNA—representing the complete elimination of ctDNA—preceded any observable response on imaging scans, with a median lead time of 11.5 months. This underscores the potential advantage of employing ctDNA for response assessment.
These studies constitute a portion of the substantial body of evidence being generated by both Foundation Medicine and Natera, affirming the value of incorporating tissue-informed ctDNA monitoring into clinical practice.