Albumin fusion proteins
First Claim
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1. An albumin fusion protein comprising a member selected from the group consisting of:
- (a) a Therapeutic protein;
X and albumin comprising the amino acid sequence of SEQ ID NO;
1;
(b) a Therapeutic protein;
X and a fragment or a variant of the amino acid sequence of SEQ ID NO;
1, wherein said fragment or variant has albumin activity;
(c) a Therapeutic protein;
X and a fragment or a variant of the amino acid sequence of SEQ ID NO;
1, wherein said fragment or variant has albumin activity, and further wherein said albumin activity is the ability to prolong the shelf life of the Therapeutic protein;
X compared to the shelf-life of the Therapeutic protein;
X in an unfused state;
(d) a Therapeutic protein;
X and a fragment or a variant of the amino acid sequence of SEQ ID NO;
1, wherein said fragment or variant has albumin activity, and further wherein the fragment or variant comprises the amino acid sequence of amino acids 1-387 of SEQ ID NO;
1;
(e) a fragment or variant of a Therapeutic protein;
X and albumin comprising the amino acid sequence of SEQ ID NO;
1, wherein said fragment or variant has a biological activity of the Therapeutic protein;
X;
(f) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (e), wherein the Therapeutic protein;
X, or fragment or variant thereof, is fused to the N-terminus of albumin, or the N-terminus of the fragment or variant of albumin;
(g) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (e), wherein the Therapeutic protein;
X, or fragment or variant thereof, is fused to the C-terminus of albumin, or the C-terminus of the fragment or variant of albumin;
(h) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (e), wherein the Therapeutic protein;
X, or fragment or variant thereof, is fused to the N- terminus and C-terminus of albumin, or the N-terminus and the C-terminus of the fragment or variant of albumin;
(i) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (e), which comprises a first Therapeutic protein;
X, or fragment or variant thereof, and a second Therapeutic protein;
X, or fragment or variant thereof, wherein said first Therapeutic protein;
X, or fragment or variant thereof, is different from said second Therapeutic protein;
X, or fragment or variant thereof;
(j) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (i), wherein the Therapeutic protein;
X, or fragment or variant thereof, is separated from the albumin or the fragment or variant of albumin by a linker; and
(k) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (j), wherein the albumin fusion protein has the following formula;
R1-L-R2;
R2-L-R1;
or R1-L-R2-L-R1, wherein R1 is Therapeutic protein;
X, or fragment or variant thereof, L is a peptide linker, and R2 is albumin comprising the amino acid sequence of SEQ ID NO;
1 or a fragment or variant of albumin;
wherein said Therapeutic protein;
X is a human growth hormone, an interferon alpha, an interferon beta, a natriuretic peptide, a lysosomal glucocerebrosidase, a brain-derived neurotrophic factor isoform, a glucagon-like peptide 1, an arginine deiminase, a uricase, an interferon hybrid, an interleukin-2, an adrenomedullin, a tweak Receptor, a Kiss-1, an ephrin B1, or a B7-H3.
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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
22 Claims
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1. An albumin fusion protein comprising a member selected from the group consisting of:
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(a) a Therapeutic protein;
X and albumin comprising the amino acid sequence of SEQ ID NO;
1;
(b) a Therapeutic protein;
X and a fragment or a variant of the amino acid sequence of SEQ ID NO;
1, wherein said fragment or variant has albumin activity;
(c) a Therapeutic protein;
X and a fragment or a variant of the amino acid sequence of SEQ ID NO;
1, wherein said fragment or variant has albumin activity, and further wherein said albumin activity is the ability to prolong the shelf life of the Therapeutic protein;
X compared to the shelf-life of the Therapeutic protein;
X in an unfused state;
(d) a Therapeutic protein;
X and a fragment or a variant of the amino acid sequence of SEQ ID NO;
1, wherein said fragment or variant has albumin activity, and further wherein the fragment or variant comprises the amino acid sequence of amino acids 1-387 of SEQ ID NO;
1;
(e) a fragment or variant of a Therapeutic protein;
X and albumin comprising the amino acid sequence of SEQ ID NO;
1, wherein said fragment or variant has a biological activity of the Therapeutic protein;
X;
(f) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (e), wherein the Therapeutic protein;
X, or fragment or variant thereof, is fused to the N-terminus of albumin, or the N-terminus of the fragment or variant of albumin;
(g) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (e), wherein the Therapeutic protein;
X, or fragment or variant thereof, is fused to the C-terminus of albumin, or the C-terminus of the fragment or variant of albumin;
(h) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (e), wherein the Therapeutic protein;
X, or fragment or variant thereof, is fused to the N- terminus and C-terminus of albumin, or the N-terminus and the C-terminus of the fragment or variant of albumin;
(i) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (e), which comprises a first Therapeutic protein;
X, or fragment or variant thereof, and a second Therapeutic protein;
X, or fragment or variant thereof, wherein said first Therapeutic protein;
X, or fragment or variant thereof, is different from said second Therapeutic protein;
X, or fragment or variant thereof;
(j) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (i), wherein the Therapeutic protein;
X, or fragment or variant thereof, is separated from the albumin or the fragment or variant of albumin by a linker; and
(k) a Therapeutic protein;
X, or fragment or variant thereof, and albumin, or fragment or variant thereof, of (a) to (j), wherein the albumin fusion protein has the following formula;
R1-L-R2;
R2-L-R1;
or R1-L-R2-L-R1,wherein R1 is Therapeutic protein;
X, or fragment or variant thereof, L is a peptide linker, and R2 is albumin comprising the amino acid sequence of SEQ ID NO;
1 or a fragment or variant of albumin;
wherein said Therapeutic protein;
X is a human growth hormone, an interferon alpha, an interferon beta, a natriuretic peptide, a lysosomal glucocerebrosidase, a brain-derived neurotrophic factor isoform, a glucagon-like peptide 1, an arginine deiminase, a uricase, an interferon hybrid, an interleukin-2, an adrenomedullin, a tweak Receptor, a Kiss-1, an ephrin B1, or a B7-H3. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19, 20, 21, 22)
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16. A method of extending the shelf life or plasma stability of Therapeutic protein:
- X, or fragment or variant thereof, comprising the step of fusing the Therapeutic protein;
X, or fragment or variant thereof, to albumin, or fragment or variant thereof, sufficient to extend the shelf-life or plasma stability of the Therapeutic protein;
X, or fragment or variant thereof, compared to the shelf-life of the Therapeutic protein;
X, or fragment or variant thereof, in an unfused state.
- X, or fragment or variant thereof, comprising the step of fusing the Therapeutic protein;
Specification