Claims for Patent: 7,847,079

Summary for Patent: 7,847,079

Title:	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.
Inventor(s):	Rosen; Craig A. (Laytonsville, MD), Haseltine; William A. (Washington, DC), Ruben; Steven M. (Brookeville, MD)
Assignee:	Human Genome Sciences, Inc. (Rockville, MD)
Application Number:	11/429,374
Patent Claims:	1. A nucleic acid molecule comprising a first polynucleotide encoding two or more tandem GLP-1 polypeptides, wherein said GLP-1 polypeptides are selected from wild-type GLP-1, GLP-1 fragments, and GLP-1 variants, and a second polynucleotide encoding human albumin or a human albumin fragment or variant thereof. 2. The nucleic acid molecule of claim 1, wherein said encoded tandem GLP-1 polypeptides are wild-type GLP-1. 3. The nucleic acid molecule of claim 1, wherein said encoded tandem GLP-1 polypeptides are GLP-1 fragments. 4. The nucleic acid molecule of claim 1, wherein said encoded tandem GLP-1 polypeptides are GLP-1 variants. 5. The nucleic acid molecule of claim 1, wherein said encoded tandem GLP-1 polypeptides are at least one wild-type GLP-1 and at least one GLP-1 fragment. 6. The nucleic acid molecule of claim 1, wherein said encoded tandem GLP-1 polypeptides are at least one wild-type GLP-1 and at least one GLP-1 variant. 7. The nucleic acid molecule of claim 1, wherein said encoded tandem GLP-1 polypeptides are at least one GLP-1 fragment and at least one GLP-1 variant. 8. The nucleic acid molecule of claim 1, wherein said encoded GLP-1 fragments or GLP-1 variants are selected from the group: a. GLP-1(9-36); b. GLP-1(7-36); c. GLP-1(7-36(A8G)); and d. GLP-1(7-36(A8S)). 9. The nucleic acid molecule of claim 8, wherein said encoded GLP-1 variants are two tandem GLP-1(7-36(A8G)). 10. The nucleic acid molecule of claim 9, wherein said two tandem GLP-1(7-36(A8G)) variants are positioned at the N-terminus of albumin. 11. The nucleic acid molecule of claim 9, wherein said two tandem GLP-1(7-36(A8G)) variants are positioned at the C-terminus of albumin. 12. The nucleic acid molecule of claim 1, wherein said encoded tandem GLP-1 polypeptides are positioned at the N-terminus of albumin. 13. The nucleic acid molecule of claim 1, wherein said encoded tandem GLP-1 polypeptides are positioned at the C-terminus of albumin. 14. An albumin fusion construct comprising the nucleic acid molecule of claim 1, which upon expression in a host produces an albumin fusion protein comprising two or more tandem GLP-1 polypeptides fused to human albumin or a human albumin fragment or variant thereof, wherein said albumin fusion construct is selected from the group: a. 2900; b. 2964; c. 2803; d. 2804; e. 2945; f. 2982; g. 3070; h. 3027; i. 3028; j. 3045; k. 3046; l. 3069; m. 3071; n. 3072; o. 3085; p. 3086; q. 3087; r. 3309; and s. 2904. 15. The nucleic acid molecule of claim 1, which encodes an N-terminal methionine. 16. The nucleic acid molecule of claim 1, which encodes a signal sequence. 17. The nucleic acid molecule of claim 1, which comprises a heterologous polynucleotide. 18. The nucleic acid molecule of claim 17, wherein said heterologous polynucleotide is at least one selected from a vector sequence, a promoter sequence, a selectable marker, and a region for termination of transcription. 19. The nucleic acid molecule of claim 1, which is part of an expression cassette. 20. A vector comprising the nucleic acid molecule of claim 1. 21. An isolated host cell comprising the nucleic acid molecule of claim 1. 22. An isolated host cell comprising the vector of claim 20. 23. The isolated host cell of claim 21 or 22, which is prokaryotic or eukaryotic. 24. The isolated host cell of claim 23, which is a yeast cell. 25. The isolated host cell of claim 24, wherein said yeast cell is S. cerevisiae. 26. The isolated host cell of claim 23, which is a mammalian cell. 27. The isolated host cell of claim 26, wherein said mammalian cell is a CHO cell. 28. The nucleic acid molecule of claim 1, wherein said encoded GLP-1 polypeptides comprise at least one amino acid sequence selected from the group: (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. 29. The nucleic acid molecule of claim 1, comprising an amino acid sequence selected from the group: (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. 30. A nucleic acid molecule comprising the cDNA contained in ATCC Deposit No. PTA-4671.

Details for Patent 7,847,079

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2021-12-21
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2021-12-21
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2021-12-21
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2021-12-21
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2021-12-21
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003		2021-12-21
Csl Behring Llc	ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5	albumin (human)	Injection	103955	03/17/2000		2021-12-21