Day One Announces First Patients Dosed in Phase 1b/2 Combination Study with Tovorafenib (DAY101) and Pimasertib in RAF-altered Solid Tumors
SOUTH SAN FRANCISCO, Calif., May 23, 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 the first patients have been dosed in sub-study 2 of FIRELIGHT-1, a Phase 1b/2 clinical trial evaluating tovorafenib (DAY101) in combination with pimasertib in adolescent and adult patients with recurrent, progressive, or refractory solid tumors with MAPK pathway aberrations.
Tovorafenib is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor and pimasertib is an investigational, oral, highly-selective small molecule inhibitor of mitogen-activated protein kinases 1 and 2 (MEK-1/-2). Both investigational therapies are designed to target key enzymes in the MAPK signaling pathway.
“The MAPK pathway is one of the most commonly dysregulated cancer signaling pathways. A growing body of preclinical data indicates that the combination of a type II RAF inhibitor and a MEK inhibitor may have synergistic activity against tumors bearing a variety of different MAPK pathway alterations. We are excited to expand the development of both tovorafenib and pimasertib and further characterize the potential of combination therapy in adolescent and adult patients with treatment-resistant MAPK pathway-altered solid tumors,” said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. “Extending our research into the combination setting in adult and adolescent patients is a logical next step as it allows us to build on tovorafenib’s monotherapy activity and uncover its full therapeutic potential in tumors with unaddressed MAPK alterations.”
The Phase 1b portion of the multi-center, open-label umbrella study will evaluate the safety of combining tovorafenib once weekly with pimasertib in approximately 25 adolescent and adult patients (= 12 years of age) to determine optimal dosing. Secondary and exploratory endpoints evaluate duration to response, progression-free survival, and time to response. The Phase 2 portion will evaluate the efficacy and safety of the optimal dose combination from Phase 1b across one or more genomically-defined expansion cohorts. Additional information may be found at ClinicalTrials.gov, using Identifier NCT04985604.
Day One is conducting a Phase 1b/2 study (FIRELIGHT-1) to evaluate the safety, tolerability, and preliminary efficacy of combining pimasertib with tovorafenib in adolescent and adult patients (=12 years of age) with recurrent, progressive, or refractory solid tumors with MAPK pathway aberrations.
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, is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor and the 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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