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    Delta-Fly Pharma Inc.: Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 Combined with Venetoclax

    Details:

    DFP-10917 (radgocitabine) is a DNA polymerase inhibitor small molecule drug candidate which is being evaluated in combination with venetoclax for the treatment of acute myeloid leukemia.


    Lead Product(s): Radgocitabine,Venetoclax

    Therapeutic Area: Oncology Product Name: DFP-10917

    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 April 08, 2024

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    Delta-Fly Pharma Inc.: FDA Submission of the Protocol of the Phase I/II study of DFP-10917 Combined with Venetoclax (VTX) in the AML Patients Pretreated...

    Details:

    DFP-10917 (radgocitabine) is a DNA polymerase inhibitor small molecule drug candidate which is being evaluated in combination with venetoclax for the treatment of acute myeloid leukemia.


    Lead Product(s): Radgocitabine,Venetoclax

    Therapeutic Area: Oncology Product Name: DFP-10917

    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 March 11, 2024

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    Delta-Fly Pharma Inc.: Notice of Initiation of Phase III Pivotal Comparative Clinical Trial of DFP-14323

    Details:

    Delta-Fly (ubenimex) is a Aminopeptidase N inhibitor. It is being evaluated in phase 3 clinical trials in combination with afatinib for the treatment of stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation.


    Lead Product(s): ubenimex,Afatinib

    Therapeutic Area: Oncology Product Name: DFP-14323

    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 02, 2024

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    Phase 3 Study of DFP-10917 in the R/R AML Patients Shall Be Done with the 1st Interim Analysis for NDA Approval.

    Details:

    DFP-10917 (radgocitabine) is a nucleoside analog delivered as a low-dose continuous infusion for the treatment of relapsed/refractory acute myeloid leukemia.


    Lead Product(s): DFP-10917

    Therapeutic Area: Oncology Product Name: DFP-10917

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Nippon Shinyaku

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 15, 2023

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    Delta-Fly Pharma, Inc. is Granted Orphan Drug Designation by US Food and Drug Administration for DFP-10917

    Details:

    DFP-10917 (4-amino-1-(2-cyano-deoxy-β-D-arabinofuranosyl)-2(1H)-pyrimidinone monohydrochloride), deoxycytidine nucleoside analogue, has unique mechanism of action resulting in leukemic cell death when administered for prolonged periods at low doses.


    Lead Product(s): DFP-10917

    Therapeutic Area: Oncology Product Name: DFP-10917

    Highest Development Status: Phase IIIProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 07, 2022

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