Albumin Fusion Proteins
The present invention encompasses albumin fusion proteins. Nucleic acid molecules encodings the albumin fusion proteins of the invention are also encompassed by the invention, as are vectors containing these nucleic acids, host cells transformed with these nucleic acids vectors, and methods of making the albumin fusion proteins of the intention and using these nucleic acids, vectors, and/or host cells. Additionally the present invention encompasses pharmaceutical compositions comprising albumin fusion proteins and methods of treating, preventing, or ameliorating diseases, disorders or conditions using albumin fusion proteins of the invention.
1 - 60 . (canceled)
61 . An albumin fusion comprising a Factor VIII polypeptide fused to albumin, or albumin fragment or variant, wherein said albumin fragment or variant has the ability to prolong the serum half-life of the unfused Factor VIII polypeptide, and wherein said albumin fusion protein has Factor VIII activity.
62 . The albumin fusion protein of claim 61 wherein said Factor VIII polypeptide is selected from:
a) a full-length Factor VIII;
b) an activated Factor VIII (Factor VIIIa);
c) a fragment of Factor VIII;
d) a variant of Factor VIII; and
e) a mature Factor VIII.
63 . The albumin fusion protein of claim 62 , wherein said fragment of Factor VIII is an N-terminal deletion mutant, a C-terminal deletion mutant, or an N-terminal and C-terminal deletion mutant.
64 . The albumin fusion protein of claim 61 , wherein said albumin, or albumin fragment or variant, comprises an amino acid sequence selected from:
a) amino acid residues 1 to 585 of SEQ ID NO:18; and
b) amino acid residues 1 to 387 of SEQ ID NO: 18.
65 . The albumin fusion protein of claim 61 which further comprises a second Factor VIII polypeptide.
66 . The albumin fusion protein of claim 61 , wherein said Factor VIII polypeptide is fused at the N-terminus or at the C-terminus of the albumin, or albumin fragment or variant.
67 . The albumin fusion protein of claim 61 , wherein said Factor VIII polypeptide is separated from said albumin, or albumin fragment or variant, by a linker peptide.
68 . The albumin fusion protein of claim 61 , further comprising a secretion leader sequence.
69 . The albumin fusion protein of claim 61 , which is non-glycosylated.
70 . The albumin fusion protein of claim 61 , which is expressed in yeast.
71 . The albumin fusion protein of claim 70 , wherein said yeast is a Saccharomyces cerevisiae.
72 . The albumin fusion protein of claim 70 , wherein said yeast is glycosylation deficient.
73 . The albumin fusion protein of claim 70 , wherein said yeast is glycosylation and protease deficient.
74 . The albumin fusion protein of claim 70 , wherein said fusion protein is encoded by a polynucleotide that is codon-optimized for expression in yeast.
75 . The albumin fusion protein of claim 61 , wherein said fusion protein is expressed by a mammalian cell.
76 . The albumin fusion protein of claim 75 , wherein said mammalian cell is a COS, CHO (Chinese hamster ovary), or NSO cell.
77 . A composition comprising the albumin fusion protein of claim 61 and a pharmaceutically acceptable carrier.
78 . A kit comprising the composition of claim 77 .
79 . A method of treating a patient in need of a Factor VIII polypeptide, comprising the step of administering an effective amount of the albumin fusion protein of claim 61 .
80 . A nucleic acid molecule comprising a polynucleotide sequence encoding the albumin fusion protein of claim 61 .