On September 21, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported a collaboration to develop FoundationOneCDx as a companion diagnostic for Day One’s lead investigational therapy, tovorafenib (DAY101) (Press release, Foundation Medicine, SEP 21, 2022, View Source [SID1234621313]).
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Tovorafenib is an investigational, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor, which is 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 topline results for the full pivotal study population are expected in the first quarter of 2023. Day One has also initiated a pivotal Phase 3 study (FIREFLY-2/LOGGIC) with tovorafenib in newly-diagnosed patients with pLGG and tovorafenib is additionally being evaluated alone and as a combination therapy for other recurrent or progressive solid tumors with MAPK pathway aberrations.
"New advancements in pediatric cancer research, including novel targeted therapies and companion diagnostics, have the ability to provide a more precise perspective into a patient’s disease helping to inform a tailored therapeutic strategy that may increase the odds of long-term success for children with these diseases," said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. "Combining our purposeful approach to drug development 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 offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Currently, Foundation Medicine’s tissue and blood-based tests have more than 60 companion diagnostic indications collectively in the United States and Japan and are available in more than 100 countries globally.
"Foundation Medicine and Day One Biopharmaceuticals have a shared commitment to deepening our understanding of cancer biology so we can deliver more treatment options to patients of all ages, faster," said Sanket Agrawal, Chief Biopharma Business Officer at Foundation Medicine. "We’re proud to partner with Day One to provide access to tovorafenib through companion diagnostic development once approved and look forward to our ongoing collaboration to address 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.