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Details:
The agreement provided Allarity with TKI258 (dovitinib), an oral multikinase inhibitor targeting FGF receptors, PDGF receptors and VEGF receptors, for the treatment of renal cancer.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: TKI258
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Allarity Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination February 02, 2024
Details:
Stenoparib is a dual-targeted inhibitor of PARP 1, 2 and tankyrase 1, 2 where dovitinib is a pan-tyrosine kinase inhibitor. The combination may increase the chances of cancer apoptosis and providing synergistic, enhanced antitumor activity.
Lead Product(s): Dovitinib,Stenoparib
Therapeutic Area: Oncology Product Name: TKI258
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 March 20, 2023
Details:
The DRP® platform has proven its ability to provide a statistically significant prediction of clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical studies that were examined including ongoing, prospective Phase 2 trials of Stenoparib and IXEMPRA®.
Lead Product(s): Dovitinib,Stenoparib
Therapeutic Area: Oncology Product Name: TKI258
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 02, 2022
Details:
Allarity has requested a Type C meeting with the FDA to discuss potential clinical paths to support approval of dovitinib in view of the regulatory agency’s recent Refusal to File letters for the Company’s NDA and related PMA.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: TKI258
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 March 15, 2022
Details:
NDA is supported by Allarity’s previously-filed pre-market approval submission to the FDA for the Dovitinib-DRP® companion diagnostic to select RCC patients most likely to respond to the drug.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: Dovitinib-DRP
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2021
Details:
Under the terms of the agreement, Lonza will leverage its capabilities for commercial manufacturing of small-molecules including Dovitinib and oral solid dosage forms to provide Allarity with cGMP compliant drug product supply and regulatory support towards commercialization.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: Dovitinib-DRP
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lonza Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 23, 2021
Details:
Dovitinib DRP® companion diagnostic utilizing data from Novartis’ prior Phase III trial of dovitinib in renal cell carcinoma (RCC), which can identify RCC patients that benefit from treatment with dovitinib when compared to alternative treatment with sorafenib.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: Dovitinib-DRP
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2021
Details:
Allarity’s unique and clinically validated DRP® biomarker technology makes it possible to predict whether a particular cancer patient is likely to benefit from treatment with dovitinib, in addition to a broad range of anti-cancer drugs.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: Dovitinib-DRP
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 July 05, 2021
Details:
Allarity’s focus on pediatric osteosarcoma development is based on the results of two previously reported preclinical studies in which treatment with dovitinib, compared to control treatment (sucrose solution lacking dovitinib).
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: TKI258
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oncoheroes Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2021
Details:
The e-Poster provides new details of the Dovitinib-DRP® companion diagnostic, which is used to select cancer patients most likely to respond to the pan-targeted kinase inhibitor (pan-TKI) dovitinib.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: Dovitinib-DRP
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 April 29, 2021
Details:
The allowance and imminent issuance of these three new DRP® biomarker patents further expands Allarity’s patent portfolio on unique, drug-specific DRP® biomarkers developed with its best-in-class and highly validated DRP® platform technology.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: TKI258
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 26, 2020
Details:
The Company is announcing an update on timing for its originally planned first NDA filing for dovitinib as a treatment for renal cell carcinoma (RCC). This NDA is based on non-inferiority to the approved drug sorafenib.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: TKI258
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 23, 2020
Details:
Oncology Venture has acquired the remaining 37% ownership in its priority Dovitinib program from investor Sass & Larsen ApS. As a result of the transaction, the Company now has full control of its most advanced pipeline program.
Lead Product(s): Dovitinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sass & Larsen ApS
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Agreement June 08, 2020
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