Research & Development
Foundation Medicine, Day One Biopharmaceuticals Forge Collaboration to Advance Pediatric Cancer Care
23 September 2022 - - US-based Foundation Medicine, Inc., a specialist in molecular profiling for cancer, and US-based clinical-stage biopharmaceutical company Day One Biopharmaceuticals (NASDAQ: DAWN), have forged a collaboration to develop FoundationOneCDx as a companion diagnostic for Day One's lead investigational therapy, tovorafenib (DAY101), the companies said.

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.

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.

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.

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

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research.

It collaborates with a range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership.

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 in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens.


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