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    ULTRA-LONG ACTING INSULIN-FC FUSION PROTEINS AND METHODS OF USE
    1.
    发明申请
    ULTRA-LONG ACTING INSULIN-FC FUSION PROTEINS AND METHODS OF USE 审中-公开

    公开(公告)号：WO2020006529A1

    公开(公告)日：2020-01-02

    申请号：PCT/US2019/040010

    申请日：2019-06-28

    Applicant: AKSTON BIOSCIENCES CORPORATION

    Inventor： LANCASTER, Thomas, M. ,  ZION, Todd, C.

    IPC: A61K38/00 ,  C07K7/08 ,  C07K14/76 ,  C07K14/575

    Abstract: The present disclosure provides recombinantly manufactured ultra-long acting insulin-Fc fusion proteins for use in treating canine and feline diabetes. The insulin-Fc fusion proteins comprise an insulin polypeptide linked via a peptide linker to an Fc-fragment of canine or feline origin. Based on the results obtained, creating a treatment that is amenable to low cost manufacturing, exhibits sufficient in vivo bioactivity, displays extended duration of bioactivity, does not induce anti-dmg antibodies, and substantially retains is potency over multiple administrations, requires a non-obvious combination of insulin polypeptide, peptide linkers, and species-specific Fc fragment, in addition to selective mutations on one or more of these components. Exemplary ultra-long acting insulin-Fc fusion proteins, polynucleotides encoding these insulin-Fc fusion proteins, and pharmaceutical formulations of exemplary insulin-Fc fusion proteins are provided, in addition to methods of use and preparation.

    ULTRA-LONG ACTING INSULIN-FC FUSION PROTEINS AND METHODS OF USE
    3.
    发明申请
    ULTRA-LONG ACTING INSULIN-FC FUSION PROTEINS AND METHODS OF USE 审中-公开

    公开(公告)号：WO2021011827A1

    公开(公告)日：2021-01-21

    申请号：PCT/US2020/042421

    申请日：2020-07-16

    Applicant: AKSTON BIOSCIENCES CORPORATION

    Inventor： LANCASTER, Thomas, M. ,  ZION, Todd, C.

    IPC: C07K14/62 ,  C12N15/62 ,  A61K38/28

    Abstract: The present disclosure provides recombinant ly manufactured ultra-long acting insulin-Fc fusion proteins for use in treating canine and feline diabetes. The insulin-Fc fusion proteins comprise an insulin polypeptide linked via a peptide linker to an Fc-fragment of canine or feline origin. Based on the results obtained, creating a treatment that is amenable to low cost manufacturing, exhibits sufficient in vivo bio activity, displays extended duration of bioactivity, does not induce anti-drug antibodies, and substantially retains is potency over multiple administrations, requires a non-obvious combination of insulin polypeptide, peptide linkers, and species- specific Fc fragment, in addition to selective mutations on one or more of these components. Exemplary ultra-long acting insulin-Fc fusion proteins, polynucleotides encoding these insulin-Fc fusion proteins, and pharmaceutical formulations of exemplary insulin-Fc fusion proteins are provided, in addition to methods of use and preparation.

    ULTRA-LONG ACTING INSULIN-FC FUSION PROTEINS AND METHODS OF USE
    4.
    发明申请
    ULTRA-LONG ACTING INSULIN-FC FUSION PROTEINS AND METHODS OF USE 审中-公开

    公开(公告)号：WO2021126584A1

    公开(公告)日：2021-06-24

    申请号：PCT/US2020/063673

    申请日：2020-12-07

    Applicant: AKSTON BIOSCIENCES CORPORATION

    Inventor： LANCASTER, Thomas, M. ,  ZION, Todd, C.

    IPC: C07K14/62 ,  A61P3/08 ,  C07K2319/30

    Abstract: The present disclosure provides recombinantly manufactured ultra-long acting insulin-Fc fusion proteins for use in treating diabetes. The insulin-Fc fusion proteins comprise an insulin polypeptide linked via a peptide linker to an Fc-fragment of human origin. Based on the results obtained, creating a treatment that is amenable to low cost manufacturing, exhibits sufficient in vivo bio activity, displays extended duration of bioactivity, and does not exhibit immunogenicity requires a non-obvious combination of insulin polypeptide, peptide linkers, and Fc fragment, in addition to selective mutations on one or more of these components. Exemplary ultra-long acting insulin-Fc fusion proteins, polynucleotides encoding these insulin-Fc fusion proteins, and pharmaceutical formulations of exemplary insulin-Fc fusion proteins are provided, in addition to methods of use and preparation.

    ULTRA-LONG ACTING INSULIN-FC FUSION PROTEINS AND METHODS OF USE
    6.
    发明申请
    ULTRA-LONG ACTING INSULIN-FC FUSION PROTEINS AND METHODS OF USE 审中-公开

    公开(公告)号：WO2023064711A2

    公开(公告)日：2023-04-20

    申请号：PCT/US2022/077752

    申请日：2022-10-07

    Applicant: AKSTON BIOSCIENCES CORPORATION

    Inventor： LANCASTER, Thomas M. ,  ZION, Todd C.

    IPC: A61K47/65 ,  C07K14/62 ,  A61K47/68

    Abstract: The present disclosure provides ultra-long acting insulin-Fc fusion proteins manufactured in a fungal strain for high yields and for use in treating canine and feline diabetes. The insulin-Fc fusion proteins comprise an insulin polypeptide linked via a peptide linker to an Fc-fragment of canine or feline origin. Based on the results obtained, creating a treatment that is exhibits sufficient in vivo bioactivity, displays extended duration of bioactivity, does not induce anti-drug antibodies, and substantially retains is potency over multiple administrations, requires a non-obvious combination of insulin polypeptide, peptide linkers, and species-specific Fc fragment, in addition to selective mutations on one or more of these components. Production of the insulin-Fc fusion protein in a fungal strain provides unexpectedly high yields enabling a significant reduction in manufacturing costs. Fungal strain manufactured exemplary ultra-long acting insulin-Fc fusion proteins, polynucleotides encoding these insulin-Fc fusion proteins, and pharmaceutical formulations of exemplary insulin-Fc fusion proteins are provided, in addition to methods of use and preparation.

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