IP Library › Granted Patent US 11,066,472
Granted Patent B2
US 11,066,472 · App. 16/230,356 · Granted Jul 20, 2021

Methods of treating cardiovascular disease with an anti-ASGR antibody or binding fragments thereof

Inventors: Paul Nioi (Wellesley, MA); Peter Coward (San Francisco, CA); Christopher Murawsky (Vancouver, CA)
Assignee: Amgen Inc.
C07K16/2851A61K39/3955A61K45/06A61P3/06A61P9/04A61P9/10C07H21/02C07K16/28C12N15/1138A61K2039/505A61K2039/507C07K14/705C07K14/7056C07K2317/30C07K2317/76C07K2317/77C07K2317/92C07K2317/94
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Quick Facts
Patent No.
US 11,066,472
App. No.
16/230,356
Granted
Jul 20, 2021
Kind
B2
Abstract

Antigen binding proteins that interact with ASGR, ASGR-1 and/or ASGR-2 are described as well as methods of making and using such antigen binding proteins. Methods of treating and preventing cardiovascular disease by administering a pharmaceutically effective amount of ASGR, ASGR-1 and/or ASGR-2 antigen binding proteins. Methods of treating and preventing cardiovascular disease by administering a pharmaceutically effective amount of interfering RNA compositions that reduce expression of ASGR, ASGR-1 and/or ASGR-2 are described.

Claims (47)

1. A method of treating or preventing a cardiovascular disease comprising administering to a patient in need thereof a therapeutically effective dose of an isolated antigen binding protein that binds to ASGR-1 (asialoglycoprotein receptor 1), wherein the isolated antigen binding protein is a neutralizing antibody or a neutralizing antigen binding fragment thereof.

2. The method of claim 1 , wherein said cardiovascular disease is coronary artery disease or myocardial infarction.

3. The method of claim 1 , wherein the cardiovascular disease is thereby treated.

4. The method of claim 1 , wherein the cardiovascular disease is thereby prevented.

5. A method of reducing LDL (low density lipoprotein) cholesterol levels in a patient comprising administering to a patient in need thereof a therapeutically effective dose of an isolated antigen binding protein that binds to ASGR-1 (asialoglycoprotein receptor 1), wherein the isolated antigen binding protein is a neutralizing antibody or a neutralizing antigen binding fragment thereof.

6. The method of claim 5 , wherein LDL is reduced by at least 20%.

7. The method of claim 5 , wherein the patient has coronary artery disease or myocardial infarction.

8. A method of reducing non-HDL (non-high density lipoprotein) cholesterol levels in a patient comprising administering to a patient in need thereof a therapeutically effective dose of an isolated antigen binding protein that binds to ASGR-1 (asialoglycoprotein receptor 1), wherein the isolated antigen binding protein is a neutralizing antibody or a neutralizing antigen binding fragment thereof.

9. The method of claim 8 , wherein non-HDL is reduced by at least 20%.

10. The method of claim 8 , wherein the patient has coronary artery disease or myocardial infarction.

11. A method of increasing ALP (alkaline phosphatase) levels in a patient comprising administering to a patient in need thereof a therapeutically effective dose of an isolated antigen binding protein that binds to ASGR-1 (asialoglycoprotein receptor 1), wherein the isolated antigen binding protein is a neutralizing antibody or a neutralizing antigen binding fragment thereof.

12. The method of claim 11 , wherein ALP is increased by at least 40%.

13. The method of claim 11 , wherein the patient has coronary artery disease or myocardial infarction.

14. The method of claim 1 , wherein the isolated antigen binding protein is administered sequentially with at least one agent that lowers cholesterol.

15. The method of claim 14 , wherein the at least one agent is a statin, an anti-PCSK9 inhibitor or a combination thereof.

16. The method of claim 5 , wherein the isolated antigen binding protein is administered sequentially with at least one agent that lowers cholesterol.

17. The method of claim 16 , wherein the at least one agent is a statin, an anti-PCSK9 inhibitor or a combination thereof.

18. The method of claim 8 , wherein the isolated antigen binding protein is administered sequentially with at least one agent that lowers cholesterol.

19. The method of claim 18 , wherein the at least one agent is a statin, an anti-PCSK9 inhibitor or a combination thereof.

20. The method of claim 11 , wherein the isolated antigen binding protein is administered sequentially with at least one agent that lowers cholesterol.

21. The method of claim 20 , wherein the at least one agent is a statin, an anti-PCSK9 inhibitor or a combination thereof.

22. The method of claim 1 , wherein the ASGR-1 (asialoglycoprotein receptor 1) is a human ASGR-1 having the sequence in SEQ ID NO: 32699.

23. The method of claim 5 , wherein the ASGR-1 (asialoglycoprotein receptor 1) is a human ASGR-1 having the sequence in SEQ ID NO: 32699.

24. The method of claim 8 , wherein the ASGR-1 (asialoglycoprotein receptor 1) is a human ASGR-1 having the sequence in SEQ ID NO: 32699.

25. The method of claim 11 , wherein the ASGR-1 (asialoglycoprotein receptor 1) is a human ASGR-1 having the sequence in SEQ ID NO: 32699.

26. The method of claim 1 , wherein the isolated antigen binding protein is administered parenterally.

27. The method of claim 5 , wherein the isolated antigen binding protein is administered parenterally.

28. The method of claim 8 , wherein the isolated antigen binding protein is administered parenterally.

29. The method of claim 11 , wherein the isolated antigen binding protein is administered parenterally.

30. The method of claim 1 , wherein the isolated antigen binding protein is the neutralizing antibody.

31. The method of claim 5 , wherein the isolated antigen binding protein is the neutralizing antibody.

32. The method of claim 8 , wherein the isolated antigen binding protein is the neutralizing antibody.

33. The method of claim 11 , wherein the isolated antigen binding protein is the neutralizing antibody.

34. The method of claim 1 , wherein the isolated antigen binding protein is a neutralizing human antibody.

35. The method of claim 5 , wherein the isolated antigen binding protein is a neutralizing human antibody.

36. The method of claim 8 , wherein the isolated antigen binding protein is a neutralizing human antibody.

37. The method of claim 11 , wherein the isolated antigen binding protein is a neutralizing human antibody.

38. The method of claim 1 , wherein the isolated antigen binding protein is the neutralizing antigen binding fragment of the antibody.

39. The method of claim 5 , wherein the isolated antigen binding protein is the neutralizing antigen binding fragment of the antibody.

40. The method of claim 8 , wherein the isolated antigen binding protein is the neutralizing antigen binding fragment of the antibody.

41. The method of claim 11 , wherein the isolated antigen binding protein is the neutralizing antigen binding fragment of the antibody.

42. The method of claim 1 , wherein the isolated antigen binding protein competes with an antibody having a heavy chain CDR1 sequence of SEQ ID NO: 4780, a heavy chain CDR2 sequence of SEQ ID NO: 12792, a heavy chain CDR3 sequence of SEQ ID NO: 20804, a light chain CDR1 sequence of SEQ ID NO: 772, a light chain CDR2 sequence of SEQ ID NO: 8784, and a light chain CDR3 sequence of SEQ ID NO: 16796.

43. The method of claim 5 , wherein the isolated antigen binding protein competes with an antibody having a heavy chain CDR1 sequence of SEQ ID NO: 4780, a heavy chain CDR2 sequence of SEQ ID NO: 12792, a heavy chain CDR3 sequence of SEQ ID NO: 20804, a light chain CDR1 sequence of SEQ ID NO: 772, a light chain CDR2 sequence of SEQ ID NO: 8784, and 50213, and a light chain CDR3 sequence of SEQ ID NO: 16796.

44. The method of claim 8 , wherein the isolated antigen binding protein competes with an antibody having a heavy chain CDR1 sequence of SEQ ID NO: 4780, a heavy chain CDR2 sequence of SEQ ID NO: 12792, a heavy chain CDR3 sequence of SEQ ID NO: 20804, a light chain CDR1 sequence of SEQ ID NO: 772, a light chain CDR2 sequence of SEQ ID NO: 8784, and a light chain CDR3 sequence of SEQ ID NO: 16796.

45. The method of claim 11 , wherein the isolated antigen binding protein competes with an antibody having a heavy chain CDR1 sequence of SEQ ID NO: 4780, a heavy chain CDR2 sequence of SEQ ID NO: 12792, a heavy chain CDR3 sequence of SEQ ID NO: 20804, a light chain CDR1 sequence of SEQ ID NO: 772, a light chain CDR2 sequence of SEQ ID NO: 8784, and a light chain CDR3 sequence of SEQ ID NO: 16796.

46. A method of treating a cardiovascular disease, the method comprising administering to a patient in need thereof a therapeutically effective dose of an isolated antigen binding protein that binds to ASGR-1 (asialoglycoprotein receptor 1), wherein said cardiovascular disease is coronary artery disease or myocardial infarction, and wherein the isolated antigen binding protein is a neutralizing antibody or a neutralizing antigen binding fragment thereof.

47. The method of claim 46 , wherein the isolated antigen binding protein competes with an antibody having a heavy chain CDR1 sequence of SEQ ID NO: 4780, a heavy chain CDR2 sequence of SEQ ID NO: 12792, a heavy chain CDR3 sequence of SEQ ID NO: 20804, a light chain CDR1 sequence of SEQ ID NO: 772, a light chain CDR2 sequence of SEQ ID NO: 8784, and a light chain CDR3 sequence of SEQ ID NO: 16796.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 29, 2019
From: NIOI, PAUL; COWARD, PETER; MURAWSKY, CHRISTOPHER; PIPER, DEREK E.; GARCES, FERNANDO; ZHANG, JUN; LI, YANG; CHAN, BRIAN MINGTUNG
To: AMGEN INC.
Reel/Frame 050217/0680 →
Continuity (5)
Division 15279162 · Sep 28, 2016
Provisional Application 62234546 · Sep 29, 2015
Provisional Application 62259553 · Nov 24, 2015
Provisional Application 62319740 · Apr 7, 2016
Related Publication 20190248902A1 · Aug 15, 2019
Cited By (2)
US 12,331,122 US 12,421,303