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Details:
The agreement aims to commercialize Ojemda (tovorafenib), an oral, once-weekly, type II RAF inhibitor for pediatric low grade glioma, the most common form of childhood brain cancer outside the US.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: Ojemda
Highest Development Status: DiscoveryProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ipsen
Deal Size: $461.0 million Upfront Cash: $111.0 million
Deal Type: Licensing Agreement July 25, 2024
Details:
XOMA acquired potential milestones associated with Ojemda (tovorafenib), approved for patients 6 months age and older with relapsed or refractory pediatric low-grade glioma with BRAF V600 mutation.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: Ojemda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Viracta Therapeutics
Deal Size: $108.0 million Upfront Cash: Undisclosed
Deal Type: Agreement June 12, 2024
Details:
Day One sold its rare pediatric disease PRV for FDA approved Ojemda (tovorafenib). It is indicated for the treatment of relapsed/refractory BRAF-mutated glioma.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: Ojemda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $108.0 million Upfront Cash: Undisclosed
Deal Type: Divestment May 30, 2024
Details:
Onco360 is being selected as a pharmacy partner by Day One Biopharmaceuticals for Ojemda, a cutting-edge treatment for children diagnosed with certain central nervous system tumors.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: Ojemda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Onco360
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership May 20, 2024
Details:
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.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: Ojemda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Day One Biopharmaceuticals
Deal Size: $54.0 million Upfront Cash: Undisclosed
Deal Type: Agreement April 25, 2024
Details:
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.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: Ojemda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2024
Details:
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.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Day One Biopharmaceuticals
Deal Size: $59.0 million Upfront Cash: Undisclosed
Deal Type: Agreement October 31, 2023
Details:
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.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 30, 2023
Details:
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.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2023
Details:
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.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $172.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 12, 2023
Details:
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.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 06, 2023
Details:
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.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2023
Details:
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.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Cancer Institute
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 17, 2022
Details:
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).
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2022
Details:
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.
Lead Product(s): Tovorafenib,Pimasertib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
DAY101 has demonstrated encouraging anti-tumor activity as a monotherapy in patient populations where MAPK pathway alterations are believed to play an important role in driving disease progression.
Lead Product(s): Tovorafenib,Pimasertib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Details:
Day One is conducting a pivotal Phase 2 clinical trial (FIREFLY-1) of DAY101 in pediatric, adolescent and young adult patients with recurrent or progressive low-grade glioma (pLGG) harboring a known BRAF alteration.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2021
Details:
The company's lead candidate, DAY101, is an oral, brain-penetrant, highly-selective type II pan-rapidly accelerated fibrosarcoma, or pan-RAF, kinase inhibitor.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $160.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 27, 2021
Details:
The company's lead candidate, DAY101, is an oral, brain-penetrant, highly-selective type II pan-rapidly accelerated fibrosarcoma, or pan-RAF, kinase inhibitor.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $126.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 24, 2021
Details:
Proceeds to be used to advance the development of DAY101 in pivotal Phase 2 clinical trial as a monotherapy for children with pLGG, in a Phase 3 clinical trial as a potential frontline therapy in pLGG, and in a Phase 2 clinical trial in adult RAS/RAF-altered solid tumors.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P Morgan
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 05, 2021
Details:
Exclusive license agreement broadens Day One’s clinical-stage pipeline of targeted cancer therapies with the additions of pimasertib and MSC2015103B. Day One plans to study the combination of pimasertib and DAY101 in patients ≥12 years of age with advanced solid tumors.
Lead Product(s): Pimasertib,Tovorafenib
Therapeutic Area: Oncology Product Name: MSC19363639B
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Day One Biopharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement February 23, 2021
Details:
Proceeds will support continued development and commercial launch planning for DAY101, the Company’s clinical-stage, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor for pediatric and adult RAF-altered cancers, including low-grade glioma.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: DAY101
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: RA Capital Management
Deal Size: $130.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing February 10, 2021
Details:
The objective of the PNOC014 study is to assess the pharmacokinetics, safety and preliminary efficacy of DAY101 in children with recurrent or progressive pediatric low-grade gliomas and other RAS/RAF/MEK/ERK pathway activated tumors.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: TAK-580
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
The company intends to use the funds to continue to expand development of its clinical-stage oncology treatment acquired through Takeda Pharmaceutical Company Limited.
Lead Product(s): Tovorafenib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Access Biotechnology
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Series A Financing May 21, 2020