NEW YORK – Day One Biopharmaceuticals said Monday that it has partnered with the National Cancer Institute to study tovorafenib in solid tumors and hematologic cancers beyond glioma, the main indication in which it has been studied so far.
Tovorafenib is a pan-RAF kinase inhibitor targeting an enzyme in the MAPK signaling pathway. Day One has previously reported positive results from the Phase II FIREFLY-1 trial of tovorafenib in patients with relapsed low-grade glioma harboring a BRAF fusion or BRAF V600 mutation. Data from the first 22 evaluable patients showed that the drug had anti-tumor activity, and the Brisbane, California-based firm recently partnered with Foundation Medicine to develop a companion diagnostic to identify best responders.
Day One is also evaluating tovorafenib in a Phase III trial, called FIREFLY-2/LOGGIC, in newly diagnosed patients with pediatric low-grade glioma (pLGG) and in the FIRELIGHT-1 trial in patients with recurrent or progressive solid tumors with MAPK pathway aberrations.
Under the terms of the cooperative research and development agreement between the two organizations, NCI investigators will study tovorafenib in trials sponsored by its Cancer Therapy Evaluation Program. Those trials will be carried out by NCI-funded clinical networks and focus on studying solid tumor and hematologic cancers.
"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," Day One Cofounder and Chief Medical Officer Samuel Blackman said in a statement.