Albumin Fusion Proteins

Abstract

The present invention encompasses albumin fusion proteins. Nucleic acid molecules encoding 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 invention 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 - 59 . (canceled) 
     
     
         60 . An albumin fusion protein comprising an interferon beta 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 interferon beta polypeptide, and wherein said albumin fusion protein has interferon beta activity. 
     
     
         61 . The albumin fusion protein of  claim 60 , wherein said interferon beta polypeptide is selected from:
 a) a full-length interferon beta;   b) a fragment of interferon beta;   c) a variant of interferon beta; and   d) a mature interferon beta.   
     
     
         62 . The albumin fusion protein of  claim 61 , wherein said fragment of interferon beta is an N-terminal deletion mutant, a C-terminal deletion mutant, or an N-terminal and C-terminal deletion mutant. 
     
     
         63 . The albumin fusion protein of  claim 60 , 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.   
     
     
         64 . The albumin fusion protein of  claim 60 , which further comprises a second interferon beta polypeptide. 
     
     
         65 . The albumin fusion protein of  claim 60 , wherein said interferon beta polypeptide is fused at the N-terminus or at the C-terminus of the albumin, or albumin fragment or variant. 
     
     
         66 . The albumin fusion protein of  claim 60 , wherein said interferon beta polypeptide is separated from said albumin, or albumin fragment or variant, by a linker peptide. 
     
     
         67 . The albumin fusion protein of  claim 60 , further comprising a secretion leader sequence. 
     
     
         68 . The albumin fusion protein of  claim 60 , which is non-glycosylated. 
     
     
         69 . The albumin fusion protein of  claim 60 , which is glycosylated. 
     
     
         70 . The albumin fusion protein of  claim 60 , 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 60 , wherein said fusion protein is expressed by a mammalian cell. 
     
     
         75 . The albumin fusion protein of  claim 74 , wherein said mammalian cell is a COS cell, a CHO (Chinese hamster ovary) cell, or a NSO cell. 
     
     
         76 . A composition comprising the albumin fusion protein of  claim 60  and a pharmaceutically acceptable carrier. 
     
     
         77 . A kit comprising the composition of  claim 76 . 
     
     
         78 . A nucleic acid-molecule comprising a polynucleotide encoding the albumin fusion protein of  claim 60 . 
     
     
         79 . The nucleic acid molecule of  claim 78 , which is part of an expression cassette. 
     
     
         80 . A vector comprising the nucleic acid molecule of  claim 78 . 
     
     
         81 . An isolated host cell comprising the nucleic acid molecule of  claim 78 . 
     
     
         82 . An isolated host cell comprising the vector of  claim 80 . 
     
     
         83 . A method of producing an albumin fusion protein comprising:
 (a) culturing the isolated host cell of  claim 81  in conditions such that the albumin fusion protein is expressed; and   (b) recovering the albumin fusion protein.   
     
     
         84 . A method of treating a disease or disorder in a patient, comprising the step of administering the albumin fusion protein of  claim 60 .