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Last Updated: March 29, 2024

Claims for Patent: 7,550,432


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Summary for Patent: 7,550,432
Title:Recombinant fusion proteins to growth hormone and serum albumin
Abstract: The invention describes albumin fusion proteins comprising growth hormone and serum albumin. The invention also describes nucleic acid molecules encoding the albumin fusion proteins of the invention, as well as vectors containing these nucleic acid molecules, host cells transformed with these vectors, and methods of making the albumin fusion proteins of the invention and using these nucleic acids, vectors, and/or host cells. Additionally, the invention describes compositions comprising the albumin fusion proteins, and methods of treating patients in need of growth hormone, comprising administering the albumin fusion proteins of the invention.
Inventor(s): Ballance; David James (Nottingham, GB)
Assignee: Novozymes Biopharma UK Limited (Nottingham, GB)
Application Number:11/315,035
Patent Claims:1. A fusion protein comprising mature growth hormone and mature serum albumin, wherein (i) said fusion protein has a higher circulatory half-life than unfused mature growth hormone, (ii) said fusion protein retains growth hormone activity, and (iii) said mature serum albumin is located either at the N-terminus or C-terminus of said fusion protein.

2. The fusion protein of claim 1, wherein said mature growth hormone is mature human growth hormone.

3. The fusion protein of claim 1, wherein said mature serum albumin is mature human serum albumin.

4. The fusion protein of claim 1, wherein said mature growth hormone and said mature serum albumin are human.

5. The fusion protein of claim 4, wherein said fusion protein comprises a flexible linker sequence between said mature growth hormone and said mature serum albumin.

6. The fusion protein of claim 5, wherein said flexible linker sequence comprises repeating units of [Gly-Gly-Gly-Gly-Ser].sub.2 (SEQ ID NO:16) or [Gly-Gly-Gly-Gly-Ser].sub.3 (SEQ ID NO:17).

7. The fusion protein of claim 4, wherein said fusion protein comprises a leader sequence.

8. The fusion protein of claim 7, wherein said leader sequence is an HSA/MF.alpha.-1 hybrid leader sequence.

9. The fusion protein of claim 7, wherein said leader sequence is selected from: (a) an invertase leader sequence; (b) an acid phosphatase leader sequence; (c) a pre-sequence of MF.alpha.-1; (d) a pre-sequence of .beta.-glucanase; (e) a pre-sequence of killer toxin; (f) a glucoamylase II leader sequence; (g) an .alpha.-galactosidase leader sequence; (h) a killer toxin leader sequence; and (i) a glucoamylase leader sequence.

10. The fusion protein of claim 4, wherein the C-terminus of said mature serum albumin is fused to the N-terminus of said mature growth hormone.

11. The fusion protein of claim 4, wherein the N-terminus of said mature serum albumin is fused to the C-terminus of said mature growth hormone.

12. The fusion protein of claim 4, wherein said fusion protein is expressed by a host cell selected from: (a) a bacterial cell; (b) an animal cell; (c) a fungal cell; (d) a plant cell; and (e) an insect cell.

13. The fusion protein of claim 4, wherein said fusion protein is expressed by a yeast.

14. The fusion protein of claim 13, wherein said yeast is S. cerevisiae.

15. The fusion protein of claim 13, wherein said yeast is selected from: (a) S. italicus; (b) S. rouxii; (c) K. fragilis; (d) K. lactis; (e) K. marxianus; (f) T. delbrueckii; (g) P. angusta; (h) P. anomala; and (i) P. pastoris.

16. A nucleic acid molecule comprising a polynucleotide encoding the fusion protein of claim 4.

17. The nucleic acid molecule of claim 16, which comprises a heterologous polynucleotide.

18. The nucleic acid molecule of claim 17, wherein said heterologous polynucleotide is a vector sequence.

19. The nucleic acid molecule of claim 17, wherein said heterologous polynucleotide is a promoter sequence.

20. A composition comprising one or more recombinant fusion proteins of claim 1.

21. A composition comprising one or more recombinant fusion proteins of claim 4.

22. An isolated host cell comprising the nucleic acid molecule of claim 16.

23. An isolated host cell comprising the nucleic acid molecule of claim 17.

24. A method of treating a patient in need of growth hormone, comprising administering an effective dosage of the fusion protein of claim 1.

Details for Patent 7,550,432

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 ⤷  Try a Trial 2015-12-30
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2015-12-30
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2015-12-30
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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