Factor IX Polypeptides and Methods of Use Thereof
AssigneeBiogen Idec Hemophilia Inc.
InventorsGlenn Pierce, Samantha Truex, Robert T. Peters, Haiyan Jiang
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Abstract
The present invention provides methods of administering Factor IX; methods of administering chimeric and hybrid polypeptides comprising Factor IX; polynucleotides encoding such chimeric and hybrid polypeptides; cells comprising such polynucleotides; and methods of producing such chimeric and hybrid polypeptides using such cells.
Claims121
A method of administering Factor IX to a human subject in need thereof, comprising administering to the subject a dose of at least about 25 IU/kg of a chimeric polypeptide comprising Factor IX and a FcRn binding partner (FcRn BP) at about a once weekly or longer dosing interval.
A method of administering Factor IX to a human subject in need thereof, comprising administering to the subject a dose of at least about 10 or at least about 20 IU/kg of a chimeric polypeptide comprising Factor IX and a FcRn binding partner (FcRn BP) at about a once weekly or longer dosing interval.
A method of administering Factor IX to a human subject in need thereof, comprising administering to the subject a dose of at least about 10 IU/kg of a chimeric polypeptide comprising Factor IX and XTEN at about a once weekly or longer dosing interval.
A polypeptide comprising a Factor IX at least 90% or 95% identical to a Factor IX amino acid sequence shown in Table 2A without a signal sequence and propeptide (amino acids 1 to 415 of SEQ ID NO:2), and a FcRn BP.
A polypeptide comprising a Factor IX at least 90% or 95% identical to a Factor IX amino acid sequence shown in Table 2A with a signal sequence and propeptide and propeptide (amino acids −46 to 415 of SEQ ID NO:2), and a FcRn BP.
A recombinant factor IX (rFIX) preparation, which has an incremental recovery (K-Value) in humans greater than 0.75 IU/dL per IU/kg and wherein less than 25% of the rFIX in the preparation is fully phosphorylated and sulfated.
Dependencies are inferred from the claim text.