Foundation Medicine and Day One Biopharmaceuticals Announce Global Collaboration to Advance Pediatric Cancer Care

Foundation Medicine and Day One Biopharmaceuticals Announce Global Collaboration to Advance Pediatric Cancer Care

CAMBRIDGE, Mass. & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Foundation Medicine, Inc., a pioneer in cancer molecular profiling, and Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with cancer. life-threatening diseases, today announced a collaboration to develop FoundationOne®CDx as a Companion Diagnostic for Day One’s Lead Investigational Treatment, Tovorafenib (DAY101).

Tovorafenib is an investigational, oral, brain-penetrating, pan-RAF kinase type II inhibitor currently being evaluated in an ongoing pivotal Phase 2 clinical trial (FIREFLY-1) for the treatment of pediatric, adolescent and young adult patients with relapsed pediatric low-grade glioma (pLGG). In June 2022, Day One reported positive initial data from the FIREFLY-1 study and the first results for the entire pivotal study population are expected in the first quarter of 2023. Day One has also launched a pivotal phase 3 study (FIREFLY-2/LOGGIC) with tovorafenib in newly diagnosed patients with pLGG and tovorafenib is also being evaluated alone and as combination therapy for other recurrent or progressive solid tumors with pathway aberrations MAPK.

“New advances in pediatric cancer research, including new targeted therapies and companion diagnostics, have the ability to provide a more accurate perspective of a patient’s disease, helping to inform a tailored treatment strategy that can increase the chances of long-term success for children with these conditions,” said Samuel Blackman, MD, Ph.D., co-founder and chief medical officer of Day One. “The combination of our targeted approach to the development of drugs with Foundation Medicine’s genomic profiling expertise and global reach will enable greater patient access to tovorafenib once approved and ultimately help more children living with this debilitating form of cancer.

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests provides physicians with blood and tissue testing options to detect genomic alterations that help guide personalized treatment decisions. Currently, Foundation Medicine’s tissue and blood tests collectively have more than 60 companion diagnostic indications in the United States and Japan and are available in more than 100 countries worldwide.

“Foundation Medicine and Day One Biopharmaceuticals have a shared commitment to deepening our understanding of cancer biology so that we can bring more treatment options to patients of all ages, faster,” said Sanket Agrawal, Chief Biopharmaceutical Affairs Officer. at Foundation Medicine. “We are proud to partner with Day One to provide access to tovorafenib through the development of companion diagnostics once approved and look forward to our continued collaboration to address the significant unmet needs in pediatric oncology.

If tovorafenib and this companion diagnostic indication are approved, this would be the first companion diagnostic indication for FoundationOne CDx in pediatric oncology.

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.

About Foundation One®CDx

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 a tumor mutation profile 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 http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

Basic medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

About Day One Biopharmaceuticals

Day One Biopharmaceuticals is a clinical-stage biopharmaceutical company that believes that when it comes to pediatric cancer, we can do better. We put children first and develop targeted therapies that meet their needs. Day One was founded to address a critical unmet need: the glaring lack of therapeutic development in pediatric cancer. The company’s name was inspired by “The Day One Talk” doctors have with patients and their families about an initial cancer diagnosis and treatment plan. Day One aims to rethink cancer drug development and redefine what is possible for all people with cancer, regardless of age, from day one.

Day One partners with leading clinical oncologists, families and scientists to identify, acquire and develop important emerging cancer treatments. The Company’s lead product candidate, tovorafenib (DAY101), is an investigational, brain-penetrating, highly selective pan-RAF kinase type II inhibitor. The Company’s pipeline also includes pimasertib, an experimental, oral, highly selective small molecule inhibitor of mitogen-activated protein kinases 1 and 2 (MEK-1/-2). Day One is based in South San Francisco. For more information, visit www.dayonebio.com or search for the company on LinkedIn or Twitter.

About tovorafenib

Tovorafenib is an investigational, highly selective, oral, brain-penetrating pan-RAF kinase type II inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being studied in primary brain tumors and solid tumors. harboring RAF-activating alterations. Tovorafenib has been studied in over 325 patients to date. Currently, tovorafenib is being evaluated in a pivotal Phase 2 clinical trial (FIREFLY-1) in pediatric, adolescent, and young adult patients with relapsed pediatric low-grade glioma (pLGG), which is an area where there is considerable unmet need and no approved treatment for the majority of sufferers. Day One also initiated a pivotal Phase 3 study (FIREFLY-2/LOGGIC) in newly diagnosed patients with pLGG. Beyond pLGG, tovorafenib is being evaluated alone or in combination for adolescent and adult patient populations with recurrent or progressive solid tumors with MAPK (FIRELIGHT-1) pathway aberrations. Tovorafenib has received Breakthrough Therapy and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG with activating alteration of RAF. Tovorafenib has also received orphan drug designation from the FDA for the treatment of malignant glioma and from the European Commission (EC) for the treatment of glioma.

Day One Biopharmaceuticals Caution Regarding Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s plans to develop therapies against cancer, the timing or success of the development of a companion diagnostic using FoundationOne Liquid CDx, the expectations of ongoing clinical trials, the execution of the Phase 2 and Phase 3 clinical trial for tovorafenib (DAY101 ) as designed, any expectations regarding safety, efficacy, timing and ability to complete clinical trials, release data results and obtain regulatory approvals for tovorafenib (DAY101) and other candidates in development, as well as the ability of tovorafenib (DAY101) to treat pLGG or related indications.

Statements including words such as “believe”, “plan”, “continue”, “expect”, “should”, “develop”, “signal”, “potential” or “in progress” and statements in the future tense are statements looking. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if not fully realized or prove to be incorrect, could cause our results to differ materially from those expressed or implied by these forward-looking statements. .

Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual business or results to differ materially from those expressed in any forward-looking statement, including the risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Day One’s ability to develop, obtain regulatory approval or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of the COVID-19 pandemic and the sufficiency of cash, cash equivalents and investments to finance its activities. These forward-looking statements speak only as of the date hereof, and Day One specifically disclaims any obligation to update such forward-looking statements or the reasons why actual results may differ, whether as a result of new information, future events or otherwise, except as necessary. by the law.

Source: Foundation Medicine


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