ULTRA-LONG ACTING INSULIN-FC FUSION PROTEINS AND METHODS OF USE

    公开(公告)号:US20240182539A1

    公开(公告)日:2024-06-06

    申请号:US18581048

    申请日:2024-02-19

    CPC classification number: C07K14/62 C07H21/04 C07K2319/30 C07K2319/70 C12N5/16

    Abstract: The present disclosure provides recombinantly manufactured ultra-long acting insulin-Fc fusion proteins for use in treating canine diabetes. The insulin-Fc fusion proteins comprise an insulin polypeptide linked via a peptide linker to an Fc-fragment of canine 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-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.

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