Day One Biopharmaceuticals
Biopharmaceutical company focused on developing targeted oncology therapies for pediatric and adult patients. Activities include discovery and preclinical development, early- and late-stage clinical trials (Phase 1–3), regulatory interactions resulting in an FDA approval for a pediatric indication, and partnerships to enable global commercialization. The organization also supports investigator-sponsored trials and maintains a patient advocacy engagement program.
Industries
Nr. of Employees
medium (51-250)
Day One Biopharmaceuticals
Patents
Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation
US-10426782-B2
View DetailsSubstituted 1,3-thiazoles as synthetic intermediates for preparation of Raf kinase inhibitors
US-9556177-B2
View Details
Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation
US-10426782-B2
View DetailsSubstituted 1,3-thiazoles as synthetic intermediates for preparation of Raf kinase inhibitors
US-9556177-B2
View DetailsProducts
Tovorafenib (oral Type II RAF kinase inhibitor)
Orally administered, brain-penetrant Type II RAF kinase inhibitor developed to target MAPK signaling in tumors with activating RAF alterations; approved for a pediatric indication and investigated in front-line and relapsed settings.
DAY301 (PTK7-directed ADC)
Antibody–drug conjugate targeting PTK7 under clinical investigation in Phase 1 for locally advanced or metastatic solid tumors; designed to optimize therapeutic index.
Emi-Le (B7-H4-directed ADC)
Clinical-stage antibody–drug conjugate directed against B7-H4 under Phase 1 investigation for recurrent or advanced solid tumors (including adenoid cystic carcinoma).
Tovorafenib (oral Type II RAF kinase inhibitor)
Orally administered, brain-penetrant Type II RAF kinase inhibitor developed to target MAPK signaling in tumors with activating RAF alterations; approved for a pediatric indication and investigated in front-line and relapsed settings.
DAY301 (PTK7-directed ADC)
Antibody–drug conjugate targeting PTK7 under clinical investigation in Phase 1 for locally advanced or metastatic solid tumors; designed to optimize therapeutic index.
Emi-Le (B7-H4-directed ADC)
Clinical-stage antibody–drug conjugate directed against B7-H4 under Phase 1 investigation for recurrent or advanced solid tumors (including adenoid cystic carcinoma).
Services
Review and potential support for investigator-initiated clinical studies, including requests for drug supply or funding under written agreement.
Review and potential support for investigator-initiated clinical studies, including requests for drug supply or funding under written agreement.
Expertise Areas
- Clinical trial management
- Biomarker-guided oncology development
- Antibody–drug conjugate development
- Small-molecule MAPK pathway inhibitors
Key Technologies
- Antibody–drug conjugates (ADC)
- Type II RAF kinase inhibitors
- MAPK pathway targeting
- Brain-penetrant small-molecule design
News & Updates
Company overview and strategic priorities for 2025, including mention of FDA approval for a pediatric indication and ongoing Phase 3 FIREFLY-2 and Phase 1 ADC studies.
FDA approval in April 2024 for treatment of children with relapsed or refractory pediatric low-grade glioma harboring activating RAF alterations.
Company overview and strategic priorities for 2025, including mention of FDA approval for a pediatric indication and ongoing Phase 3 FIREFLY-2 and Phase 1 ADC studies.
FDA approval in April 2024 for treatment of children with relapsed or refractory pediatric low-grade glioma harboring activating RAF alterations.