IP Library Granted Patent US 9,657,095
Granted Patent B2
US 9,657,095 · App. 14/662,538 · Granted May 23, 2017

Antibodies specific for sclerostin and methods for increasing bone mineralization

Inventors: David G. Winkler (Arlington, MA); Jiye Shi (Rochester, NY); John Latham (Seattle, WA)
Assignee: UCB PHARMA S.A.
C07K16/22A61K47/4833A61K47/48284C07K14/475C07K14/51C07K16/18G01N33/6854C07K2317/76G01N2333/4704
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Quick Facts
Patent No.
US 9,657,095
App. No.
14/662,538
Granted
May 23, 2017
Kind
B2
Abstract

Compositions and methods relating to antibodies that specifically bind to TGF-beta binding proteins are provided. These methods and compositions relate to altering bone mineral density by interfering with the interaction between a TGF-beta binding protein sclerostin and a TGF-beta superfamily member, particularly a bone morphogenic protein. Increasing bone mineral density has uses in diseases and conditions in which low bone mineral density typifies the condition, such as osteopenia, osteoporosis, and bone fractures.

Claims (28)

1. An IgG antibody that binds to a sclerostin polypeptide comprising an amino acid sequence set forth in SEQ ID NO: 1, wherein said antibody binds to the sequence of amino acids 57-146 of SEQ ID NO: 1 within SEQ ID NO: 1.

2. The antibody of claim 1 , wherein the antibody binds to the sequence of SEQ ID NO: 49.

3. The antibody of claim 1 , wherein the antibody binds to the sequence of SEQ ID NO: 22.

4. The antibody of claim 1 that is capable of increasing bone mineral content in a mammal.

5. The antibody of claim 1 , wherein the antibody is a monoclonal antibody.

6. The antibody of claim 1 , wherein the antibody is a human antibody, a humanized antibody or a chimeric antibody.

7. A hybridoma cell producing the antibody of claim 1 .

8. An isolated nucleic acid comprising a nucleic acid sequence encoding a heavy chain variable region of the antibody of claim 1 .

9. An isolated nucleic acid comprising a nucleic acid sequence encoding a light chain variable region of the antibody of claim 1 .

10. An isolated host cell comprising

(a) a nucleic acid comprising a nucleic acid sequence encoding a heavy chain variable region of an IgG antibody that binds to a sclerostin polypeptide comprising an amino acid sequence set forth in SEQ ID NO: 1, wherein said antibody binds to the sequence of amino acids 57-146 of SEQ ID NO: 1 within SEQ ID NO: 1,

(b) a nucleic acid comprising a nucleic acid sequence encoding a light chain variable region of an IgG antibody that binds to a sclerostin polypeptide comprising an amino acid sequence set forth in SEQ ID NO: 1, wherein said antibody binds to the sequence of amino acids 57-146 of SEQ ID NO: 1 within SEQ ID NO: 1, or

(c) the nucleic acids of (a) and (b).

11. A vector comprising

(a) a nucleic acid comprising a nucleic acid sequence encoding a heavy chain variable region of an IgG antibody that binds to a sclerostin polypeptide comprising an amino acid sequence set forth in SEQ ID NO: 1, wherein said antibody binds to the sequence of amino acids 57-146 of SEQ ID NO: 1 within SEQ ID NO: 1,

(b) a nucleic acid comprising a nucleic acid sequence encoding a light chain variable region of an IgG antibody that binds to a sclerostin polypeptide comprising an amino acid sequence set forth in SEQ ID NO: 1, wherein said antibody binds to the sequence of amino acids 57-146 of SEQ ID NO: 1 within SEQ ID NO: 1, or

(c) the nucleic acids of (a) and (b).

12. An isolated host cell comprising the vector of claim 11 .

13. A method of producing an antibody comprising the step of culturing the host cell of claim 10 and isolating an antibody produced therefrom.

14. A method of producing an antibody comprising the step of culturing the host cell of claim 12 and isolating an antibody produced therefrom.

15. A composition comprising the antibody of claim 1 and a pharmaceutically acceptable carrier.

16. A method for increasing bone mineral content in a warm-blooded animal, the method comprising administering to the warm-blooded animal the antibody of claim 1 .

17. The method of claim 16 , wherein the warm-blooded animal is a human.

18. The method of claim 17 , wherein the human has a condition selected from the group consisting of achondroplasia, cleidrocranial dysostosise, echondromatosis, fibrous dysplasia, Gaucher's hypophosphatemic rickets, Marfan's, multiple hereditary exotoses, neurofibromatosis, osteogenesis imperfecta, osteopetrosis, osteopoikilosis sclerotic lesions, fractures, periodontal disease, pseudoarthrosis, and pyogenic osteomyelitis.

19. A method of treating bone fracture in a human wherein the method comprises administering to the human the antibody of claim 1 .

20. A method of treating dysplasia associated with abnormal growth or development of bone in a human wherein the method comprises administering to the human the antibody of claim 1 .

21. A method of treating osteoporosis or osteopenia in a human wherein the method comprises administering to the human the antibody of claim 1 .

22. The method of claim 21 , wherein the osteopenia is caused by an anaemic state, steroids, heparin, a bone morrow disorder, scurvy, malnutrition, calcium deficiency, idiopathic osteoporosis, congenital osteopenia or osteoporosis, alcoholism, chronic liver disease, senility, post menstrual state, oligomenorrhea, amenorrhea, pregnancy, diabetes mellitus, hyperthyroidism, Cushing's disease, acromegaly, hypogonadism, immobilization or disuse, reflex sympathetic dystrophy syndrome, transient regional osteoporosis, or osteomalacia.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 22, 2016
From: WINKLER, DAVID G.; SHI, JIYE; LATHAM, JOHN
To: CELLTECH R&D, INC.
Reel/Frame 040398/0276 →
MERGER Recorded Nov 22, 2016
From: DARWIN MOLECULAR CORPORATION
To: UCB MANUFACTURING, INC.
Reel/Frame 040398/0300 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 22, 2016
From: UCB MANUFACTURING, INC.
To: UCB PHARMA S.A.
Reel/Frame 040398/0315 →
DISSOLUTION OF CELLTECH R&D, INC. AND SUBSEQUENT DISTRIBUTION OF ASSETS INTO DARWIN MOLECULAR CORPORATION Recorded Nov 22, 2016
From: CELLTECH R&D, INC.
To: DARWIN MOLECULAR CORPORATION
Reel/Frame 040662/0826 →
Continuity (7)
Continuation 13670259 · Nov 6, 2012
Continuation 13101434 · May 5, 2011
Continuation 12958195 · Dec 1, 2010
Division 12109029 · Apr 24, 2008
Division 10868497 · Jun 15, 2004
Provisional Application 60478977 · Jun 16, 2003
Related Publication 20150191537A1 · Jul 9, 2015