[{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"Access Biotechnology","pharmaFlowCategory":"D","amount":"$60.0 million","upfrontCash":"Undisclosed","newsHeadline":"Day One Bags $60m to Change Cancer Care and Acquires Takeda\u2019s Rights to Develop and Commercialize DAY101 Worldwide","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"RA Capital Management","pharmaFlowCategory":"D","amount":"$130.0 million","upfrontCash":"Undisclosed","newsHeadline":"Day One Announces $130 Million Series B Financing to Accelerate New Targeted Cancer Treatments for Children","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Merck Group","sponsor":"Day One Biopharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Day One Expands Clinical-Stage Oncology Pipeline; Announces Global License Agreement with Merck KGaA","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"J.P Morgan","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"Day One Biopharmaceuticals Files for $100M IPO","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"J.P. 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Morgan","pharmaFlowCategory":"D","amount":"$160.0 million","upfrontCash":"Undisclosed","newsHeadline":"Day One Announces Pricing of Upsized Initial Public Offering","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Day One Announces Preliminary Phase 1 Results for DAY101 in Pediatric Low-Grade Glioma and Gets Breakthrough Therapy Designation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Day One Receives Orphan Designation from the European Commission for DAY101 for the Treatment of Glioma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"National Cancer Institute","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Day One Announces Cooperative Research and Development Agreement with National Cancer Institute to Expand Development of Tovorafenib (DAY101)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Day One Announces First Patient Dosed in Phase 2 Monotherapy Study in RAF-altered Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"J.P. Morgan","pharmaFlowCategory":"D","amount":"$150.0 million","upfrontCash":"Undisclosed","newsHeadline":"Day One Announces Pricing of Public Offering of Common Stock","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"J.P. Morgan","pharmaFlowCategory":"D","amount":"$172.5 million","upfrontCash":"Undisclosed","newsHeadline":"Day One Announces Closing of Public Offering and Full Exercise of the Underwriters' Option to Purchase Additional Shares","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"XOMA","sponsor":"Day One Biopharmaceuticals","pharmaFlowCategory":"D","amount":"$59.0 million","upfrontCash":"Undisclosed","newsHeadline":"XOMA Earns $5 Million Milestone upon FDA Acceptance of Day One's Tovorafenib NDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 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Announces Topline Data from Pivotal Phase 2 FIREFLY-1 Trial Demonstrating Meaningful Responses with Tovorafenib (DAY101) in Recurrent or Progressive Pediatric Low-Grade Glioma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Day One Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase 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Tumor","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Tak-580
XOMA acquired potential milestones and mid-single digit royalties associated with Ojemda (tovorafenib), approved for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma harboring BRAF V600 mutation.
Ojemda (tovorafenib) is a a type II RAF inhibitor small molecule drug candidate. It is approved for the treatment of relapsed or refractory braf-altered pediatric low-grade glioma (pLGG) in patients 6 months of age and older.
Under the agreement, XOMA acquired potential royalty economics related to DAY101 (tovorafenib), an investigational, oral, brain-penetrant, highly-selective type II RAF kinase inhibitor, being developed as a monotherapy for relapsed or progressive pediatric low-grade glioma.
DAY101 (tovorafenib) is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in relapsed or progressive pediatric low-grade glioma.
DAY101 (tovorafenib) is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in primary brain tumors or brain metastases of solid tumors.
The net proceeds will be used to fund Day One’s lead product candidate, DAY101 (tovorafenib), an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor, under evaluation for the treatment of pediatric low-grade glioma (pLGG) and solid tumors.
The net proceeds will be used to fund Day One’s lead product candidate, DAY101 (tovorafenib), an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor, under evaluation for the treatment of pediatric low-grade glioma (pLGG) and solid tumors.
DAY101 (tovorafenib) is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in primary brain tumors or brain metastases of solid tumors.
Under the terms of the CRADA, NCI investigators will have the opportunity to study tovorafenib (DAY101) in CTEP-sponsored trials to be conducted by NCI funded extramural clinical networks in several solid tumor and hematologic cancers.
Data show an overall response rate (ORR) of 64% and clinical benefit rate (CBR) of 91% in the first 22 evaluable patients treated with monotherapy tovorafenib (DAY101).
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