Albumin fusion proteins
First Claim
1. A method of extending the shelf life of GLP-1 polypeptides, comprising the step of fusing two or more GLP-1 polypeptides to albumin comprising the amino acid sequence of SEQ ID NO:
- 1038, albumin fragment, or albumin variant thereof, and producing the albumin fusion protein, wherein said albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, wherein said GLP-1 polypeptides are selected from wild-type GLP-1, GLP-1 fragments, and GLP-1 variants, and wherein the albumin fusion protein has GLP-1 activity, and further wherein the two or more GLP-1 polypeptides are fused at the N-terminus and/or the C-terminus of albumin.
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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.
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Citations
67 Claims
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1. A method of extending the shelf life of GLP-1 polypeptides, comprising the step of fusing two or more GLP-1 polypeptides to albumin comprising the amino acid sequence of SEQ ID NO:
- 1038, albumin fragment, or albumin variant thereof, and producing the albumin fusion protein, wherein said albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, wherein said GLP-1 polypeptides are selected from wild-type GLP-1, GLP-1 fragments, and GLP-1 variants, and wherein the albumin fusion protein has GLP-1 activity, and further wherein the two or more GLP-1 polypeptides are fused at the N-terminus and/or the C-terminus of albumin.
- View Dependent Claims (2, 4, 5, 6, 7, 8, 9, 10, 11)
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3. A method of extending the shelf life of GLP-1 polypeptides, comprising the step of fusing two or more GLP-1 polypeptides to albumin comprising the amino acid sequence of SEQ ID NO:
- 1038, albumin fragment, or albumin variant thereof, and producing the albumin fusion protein, wherein said albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, wherein said GLP-1 polypeptides are selected from wild-type GLP-1, GLP-1 fragments, and GLP-1 variants, and wherein the albumin fusion protein has GLP-1 activity, and wherein said albumin fusion protein is produced from a host cell comprising a construct which expresses said albumin fusion protein, wherein said construct is derived from a construct selected from;
a) 2448, b) 2455, c) 2456, d) 2457, e) 2802, and f) 3140.
- 1038, albumin fragment, or albumin variant thereof, and producing the albumin fusion protein, wherein said albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, wherein said GLP-1 polypeptides are selected from wild-type GLP-1, GLP-1 fragments, and GLP-1 variants, and wherein the albumin fusion protein has GLP-1 activity, and wherein said albumin fusion protein is produced from a host cell comprising a construct which expresses said albumin fusion protein, wherein said construct is derived from a construct selected from;
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12. A method of extending the shelf life of GLP-1 polypeptides, comprising the step of fusing two or more tandemly oriented GLP-1 polypeptides to albumin comprising the amino acid sequence of SEQ ID NO:
- 1038, albumin fragment, or albumin variant thereof and producing the albumin fusion protein, wherein said albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, wherein said GLP-1 polypeptides are selected from wild-type GLP-1, GLP-1 fragments, and GLP-1 variants, and wherein the albumin fusion protein has GLP-1 activity.
- View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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34. A method of extending the shelf life of GLP-1 polypeptides, comprising the step of fusing two or more tandemly oriented GLP-1 polypeptides to albumin comprising the amino acid sequence of SEQ ID NO:
- 1038 and producing the albumin fusion protein, wherein the albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, wherein said GLP-1 polypeptides comprise at least one amino acid sequence selected from;
(a) amino acids 1 to 30 of SEQ ID NO;
1808;(b) amino acids 100 to 127 of SEQ ID NO;
1249; and(c) amino acids 98 to 127 of SEQ ID NO;
1250;and wherein said albumin fusion protein has GLP-1 activity. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51)
- 1038 and producing the albumin fusion protein, wherein the albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, wherein said GLP-1 polypeptides comprise at least one amino acid sequence selected from;
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52. A method of extending the shelf life of GLP-1 polypeptides, comprising the step of fusing two or more GLP-1 polypeptides to human serum albumin and producing the albumin fusion protein, wherein the albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, wherein said albumin fusion protein comprises an amino acid sequence derived from a sequence selected from:
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a) amino acids 25 to 639 of SEQ ID NO;
416;b) amino acids 25 to 639 of SEQ ID NO;
418;c) amino acids 25 to 654 of SEQ ID NO;
1559; andd) amino acids 25 to 655 of SEQ ID NO;
1640;and wherein said albumin fusion protein has GLP-1 activity. - View Dependent Claims (53, 54, 55, 56, 57, 58)
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59. A method of extending the shelf life of GLP-1 polypeptides, comprising the step of fusing two or more tandemly oriented GLP-1 polypeptides to human serum albumin and producing the albumin fusion protein, wherein the albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, wherein said albumin fusion protein comprises an amino acid sequence selected from:
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(a) amino acids 25 to 669 of SEQ ID NO;
1231;(b) amino acids 25 to 669 of SEQ ID NO;
1232;(c) amino acids 25 to 669 of SEQ ID NO;
1233;(d) amino acids 25 to 667 of SEQ ID NO;
1234;(e) amino acids 25 to 669 of SEQ ID NO;
1235;(f) amino acids 25 to 669 of SEQ ID NO;
1236;(g) amino acids 25 to 667 of SEQ ID NO;
1237;(h) amino acids 30 to 674 of SEQ ID NO;
1280;(i) amino acids 20 to 664 of SEQ ID NO;
1607;(j) amino acids 20 to 664 of SEQ ID NO;
1608;(k) amino acids 19 to 663 of SEQ ID NO;
1609;(l) amino acids 19 to 663 of SEQ ID NO;
1610;(m) amino acids 24 to 668 of SEQ ID NO;
1621;(n) amino acids 86 to 730 of SEQ ID NO;
1622;(o) amino acids 18 to 662 of SEQ ID NO;
1623;(p) amino acids 86 to 730 of SEQ ID NO;
1624;(q) amino acids 24 to 668 of SEQ ID NO;
1625;(r) amino acids 18 to 662 of SEQ ID NO;
1626; and(s) amino acids 30 to 673 of SEQ ID NO;
2170;and wherein said albumin fusion protein has GLP-1 activity. - View Dependent Claims (60, 61, 62, 63, 64, 65, 66)
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67. A method of extending the shelf life of GLP-1 polypeptides, comprising the step of fusing two or more tandemly oriented GLP-1 polypeptides and albumin and producing the albumin fusion protein, wherein the albumin fusion protein is sufficient to extend the shelf-life of the GLP-1 polypeptides compared to the shelf-life of the GLP-1 polypeptides in an unfused state, and wherein said albumin fusion protein is produced from a host cell comprising the amino acid sequence of the 3070 construct contained in ATCC Deposit No. PTA-4671.
Specification