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    iECURE
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    Philadelphia, PA
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    267 · 817 · 4800
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    https://iecure.com/
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    • Development Update
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    iECURE Announces FDA Clearance of Investigational New Drug Application for ECUR-506 to Initiate OTC-HOPE Trial for Treatment of Neonatal Onset Ornithine...

    Details:

    ECUR-506, incorporates an ARCUS nuclease vector targeting gene editing in the well-characterized PCSK9 gene locus and a donor vector that inserts the desired functional OTC gene for the treatment of neonatal onset ornithine transcarbamylase deficiency.


    Lead Product(s): ECUR-506

    Therapeutic Area: Genetic Disease Product Name: ECUR-506

    Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 04, 2024

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    Precision BioSciences Announces Approval of First Clinical Trial Application of ARCUS Gene Insertion Program by Partner iECURE

    Details:

    Arcus is a platform designed to develop in vivo gene editing therapies, including gene insertion, excision, and elimination. It has received TGA approval for initiation of Phase 1/2 trial evaluating ECUR-506 for the treatment of Ornithine Transcarbamylase (OTC) deficiency.


    Lead Product(s): ECUR-506

    Therapeutic Area: Genetic Disease Product Name: ECUR-506

    Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy

    Recipient: Precision BioSciences

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 13, 2023

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    iECURE Receives FDA Orphan Drug Designation for GTP-506, an Investigational Gene Editing Product Candidate for the Treatment of Ornithine Transcarbamyla...

    Details:

    GTP-506 comprises two vectors, an ARCUS® nuclease vector (GTP-506A) targeting gene editing in the well-characterized PCSK9 gene locus and a therapeutic donor vector that inserts the OTC gene.


    Lead Product(s): GTP-506A,GTP-506D

    Therapeutic Area: Genetic Disease Product Name: GTP-506

    Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 06, 2022

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    iECURE Receives FDA Rare Pediatric Disease Designation for GTP-506, an Investigational Gene Editing Product Candidate for the Treatment of Ornithine Tra...

    Details:

    GTP-506, a potential single-dose gene editing therapy designed to restore metabolic function in patients suffering with OTC deficiency, a rare urea cycle disorder.


    Lead Product(s): GTP-506A,GTP-506D

    Therapeutic Area: Genetic Disease Product Name: GTP-506

    Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 23, 2022

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    iECURE Launches With $50 Million Series A Financing to Develop In Vivo Gene Insertion Approaches for Devastating Diseases

    Details:

    The funds will be used to advance iECURE’s pipeline of up to 13 programs rely on the use of an endonuclease-based gene editing technology delivered via AAV.


    Lead Product(s): Endonuclease-based Gene Therapy

    Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

    Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Versant Ventures

    Deal Size: $50.0 million Upfront Cash: Undisclosed

    Deal Type: Series A Financing September 09, 2021

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    Precision BioSciences and iECURE Announce License and Collaboration Agreement to Develop ARCUS-Based Gene Editing Therapies

    Details:

    Under the terms of the agreement, iECURE plans to file a clinical trial application to advance the PBGENE-PCSK9 clinical candidate through Phase 1 clinical studies for the treatment of familial hypercholesterolemia (FH).


    Lead Product(s): PBGENE-PCSK9

    Therapeutic Area: Genetic Disease Product Name: PBGENE-PCSK9

    Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy

    Recipient: Precision BioSciences

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration September 09, 2021

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