Day One Announces Cooperative Research and Development Agreement with National Cancer Institute to Expand Development of Tovorafenib (DAY101)
October 17, 2022 at 08:00 AM EDT
SOUTH SAN FRANCISCO, Calif., Oct. 17, 2022 (GLOBE NEWSWIRE) -- 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, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program (CTEP) to expand therapeutic research opportunities using tovorafenib (DAY101). Under the terms of the CRADA, NCI investigators will have the opportunity to study tovorafenib in CTEP-sponsored trials to be conducted by NCI funded extramural clinical networks in several solid tumor and hematologic cancers based upon encouraging anti-tumor activity observed in previous studies.
Tovorafenib is Day One’s investigational, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway with potential broad utilization in a variety of solid tumors harboring activating RAF alterations. In June 2022, Day One reported positive initial clinical data from its ongoing pivotal Phase 2 clinical trial (FIREFLY-1) with tovorafenib for the treatment of pediatric, adolescent and young adult patients with relapsed pediatric low-grade glioma (pLGG), which is the most common brain tumor diagnosed in children and for which there are no approved therapies for the vast majority of patients, as well as no recognized standard of care.
“Our CRADA with the NCI's CTEP reinforces our strategy to maximize the extensive clinical potential of tovorafenib in a variety of RAF-altered cancer indications beyond pLGG and our other internal development efforts,” said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. “We believe this collaboration will help build upon the current development plans for tovorafenib in pediatric and adult cancers and expand the body of evidence for tovorafenib’s clinical profile, including its potential utility in multiple cancer types with MAPK alterations, which could represent indications we may choose to pursue in the future.”
About Day One Biopharmaceuticals
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, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor. The Company’s pipeline also includes pimasertib, an investigational, 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, please visit www.dayonebio.com or find the company on LinkedIn or Twitter.
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