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Details:
KHK4951 (tivozanib) is a small-molecule vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor. It is being evaluated in phase 2 clinical trials for the treatment of diabetic macular edema & neovascular (wet) age-related macular degeneration.
Lead Product(s): Tivozanib
Therapeutic Area: Ophthalmology Product Name: KHK4951
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 February 06, 2024
Details:
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor, which is investigated in Combination with OPDIVO® (nivolumab) in Advanced Renal Cell Carcinoma.
Lead Product(s): Tivozanib,Nivolumab
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bristol Myers Squibb
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2023
Details:
AVEO will establish LG Chem’s commercial presence in oncology through AVEO’s lead product, FOTIVDA® (tivozanib), which received U.S. FDA approval for the treatment of relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: LG Chem
Deal Size: $566.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 18, 2022
Details:
FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
Exploratory long-term OS analyses of TIVO-3 continue to trend in favor of Fotivda (tivozanib), patients with PFS at 1 year demonstrated a 55% reduction in risk of death on tivozanib as compared to sorafenib.
Lead Product(s): Tivozanib,Nivolumab
Therapeutic Area: Oncology Product Name: Fotivda
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 June 06, 2022
Details:
Five year follow-up data show FOTIVDA® (tivozanib), next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor patients up to 5X more likely to experience long-term PFS compared to Nexavar.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
First-line cohort of the Phase 1b/2 DEDUCTIVE study demonstrates promising efficacy and tolerability of Fotivda (tivozanib) plus Imfinzi (durvalumab) in first-line HCC.
Lead Product(s): Tivozanib,Durvalumab
Therapeutic Area: Oncology Product Name: Fotivda
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 January 20, 2022
Details:
The collaboration with NiKang, will play an important role in the advancement of both tivozanib and NKT2152 program. Under the terms of the agreement, NiKang will sponsor the trial and AVEO will co-fund the trial. Both companies will provide its respective drugs at no cost.
Lead Product(s): NKT2152,Tivozanib
Therapeutic Area: Oncology Product Name: NKT2152
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: NiKang Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 05, 2022
Details:
The net proceeds of the offering are used to support commercialization activities relating to Fotivda (tivozanib) and to advance AVEO’s pipeline. Fotivda is the first and only approved treatment specifically for advanced kidney cancer or renal cell carcinoma.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Leerink
Deal Size: $55.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 26, 2021
Details:
The net proceeds of the offering are used to support commercialization activities relating to Fotivda (tivozanib) and to advance AVEO’s pipeline. Fotivda is the first and only approved treatment specifically for advanced kidney cancer or renal cell carcinoma.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Leerink
Deal Size: $48.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 23, 2021
Details:
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). it's approved for advanced renal cell carcinoma.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2021
Details:
AVEO will evaluate FOTIVDA® (tivozanib) in combination with OPDIVO, Bristol Myers Squibb’s anti-PD-1 therapy, in the pivotal Phase 3 TiNivo-2 trial in patients with advanced relapsed or refractory renal cell carcinoma following prior immunotherapy exposure.
Lead Product(s): Tivozanib,Nivolumab
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bristol Myers Squibb
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 12, 2021
Details:
AVEO to use the funding for a successful launch of FOTIVDA in the U.S. FOTIVDA® (tivozanib), received U.S. FDA approval on March 10, 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hercules Capital
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Financing March 11, 2021
Details:
The approval of FOTIVDA is based on AVEO’s pivotal Phase 3 study, TIVO-3, comparing FOTIVDA to sorafenib in relapsed or refractory advanced RCC following two or more prior systemic therapies.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2021
Details:
Under the terms of the commitment letter, a second tranche of $20 million would be available contingent upon the approval of the tivozanib New Drug Application by the U.S. Food and Drug Administration as a treatment for relapsed or refractory renal cell carcinoma.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hercules Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 20, 2021
Details:
The Phase 2 portion of the study was designed to assess the safety, tolerability, and anti-tumor activity of the full dose and schedule of PO tivozanib, in combination with IV nivolumab.
Lead Product(s): Tivozanib,Nivolumab
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eusa Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
TIVO-3 data suggest a favorable safety and efficacy profile relative to sorafenib as demonstrated by superior anti-tumor progression free survival and overall response activity vs. another VEGFR TKI, coupled with fewer dose reductions, interruptions and discontinuations.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Details:
A second $10 million tranche is contingent upon the approval of the tivozanib New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) as a treatment for renal cell carcinoma (RCC), and certain other terms and conditions.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hercules Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing August 10, 2020
Details:
The milestone relates to acceptance by the Japanese Pharmaceuticals and Medical Devices Agency of an investigational new drug (IND) application for tivozanib in a non-oncology indication being developed by Kyowa Kirin.
Lead Product(s): Tivozanib
Therapeutic Area: Immunology Product Name: Fotivda
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: $433.5 million Upfront Cash: $25.0 million
Deal Type: Agreement August 05, 2020
Details:
The net proceeds of the offering are expected to be used for funding commercialization activities relating to Fotivda (tivozanib), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC).
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Leerink
Deal Size: $51.1 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 19, 2020
Details:
The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including funding commercialization activities relating to tivozanib.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Fotivda
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Leerink
Deal Size: $44.6 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 16, 2020
Details:
The NDA submission is based on AVEO’s pivotal Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC, including results recently presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
Details:
Phase 1b/2 DEDUCTIVE clinical trial evaluating FOTIVDA® (tivozanib) in combination with IMFINZI® (durvalumab) has demonstrated that the combination can be administered safely and the study has successfully progressed to the Phase 2 portion of the trial.
Lead Product(s): Tivozanib,Durvalumab
Therapeutic Area: Oncology Product Name: Undisclosed
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 29, 2020
Details:
Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for relapsed or refractory RCC.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Undisclosed
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 29, 2020
Details:
The NDA submission is based on the pivotal active comparator-controlled Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC patients.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020
Details:
The study sought to evaluate the safety, dosing, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of tivozanib in patients with advanced HCC.
Lead Product(s): Tivozanib
Therapeutic Area: Oncology Product Name: Undisclosed
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 February 13, 2020
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