IP Library › Granted Patent US 12,286,479
Granted Patent B2
US 12,286,479 · App. 17/239,512 · Granted Apr 29, 2025

Treatment with anti-α4β7 antibody

Inventors: Irving H. Fox (Wellesley, MA); Catherine Scholz (Woburn, MA); Erica Helen Jenkins (Cambridgeshire, GB); Maria Rosario (Mystic, CT)
Assignee: Takeda Pharmaceutical Company Limited
C07K16/2839A61K9/0019A61K39/39591A61K47/12A61K47/14A61K47/183A61K47/26A61K2039/505A61K2039/54A61K2039/545C07K2317/24
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Quick Facts
Patent No.
US 12,286,479
App. No.
17/239,512
Granted
Apr 29, 2025
Kind
B2
Abstract

Antibody formulations are described comprising a mixture of an anti-α4β7 antibody, an antioxidant or chelator, and at least one free amino acid. The disclosed formulations may have improved stability, reduced aggregate formation, or both. The present invention further provides a safe dosing regimen of these antibody formulations that is easy to follow, and which results in a therapeutically effective amount of the anti-α4β7 antibody in vivo.

Claims (55)

1. A method for treating inflammatory bowel disease (IBD) in a human patient in need thereof, the method comprising

intravenously administering an initial dose of 300 mg of a humanized antibody having binding specificity for human α4β7 integrin to the human patient,

intravenously administering a second dose of 300 mg of the humanized antibody to the human patient 2 weeks after the initial dose, and

subcutaneously administering a dose of 108 mg of the humanized antibody to the human patient via a prefilled syringe or an autoinjector every two weeks starting at 6 weeks after the initial dose,

wherein the IBD is ulcerative colitis or Crohn's disease,

wherein the treated human patient is in clinical remission, and

wherein the humanized antibody is an IgG1 isotype and comprises the following CDRs:

Light chain: CDR1 SEQ ID NO: 11

CDR2 SEQ ID NO: 12

CDR3 SEQ ID NO: 13

Heavy chain: CDR1 SEQ ID NO: 8

CDR2 SEQ ID NO: 9

CDR3 SEQ ID NO: 10.

2. The method of claim 1 , wherein the human patient had a lack of an adequate response with, loss of response to, or was intolerant to treatment with at least one of an immunomodulator, a tumor necrosis factor-alpha antagonist, or combinations thereof.

3. The method of claim 1 , where the human patient previously received treatment with at least one corticosteroid for the inflammatory bowel disease.

4. The method of claim 1 , wherein the Crohn's disease is moderately to severely active Crohn's disease.

5. The method of claim 1 , wherein the ulcerative colitis is moderately to severely active ulcerative colitis.

6. The method of claim 5 , wherein the treated human patient has mucosal healing.

7. The method of claim 1 , wherein the treated human patient reduces or discontinues use of corticosteroids.

8. The method of claim 1 , wherein the dose of 108 mg is self-administered by the human patient.

9. The method of claim 1 , wherein the humanized antibody comprises a heavy chain variable region that is at least 95% identical to amino acids 20 to 140 of SEQ ID NO:2, and a light chain variable region that is at least 95% identical to amino acids 20 to 131 of SEQ ID NO:4.

10. The method of claim 1 , wherein the humanized antibody comprises a heavy chain variable region comprising amino acids 20 to 140 of SEQ ID NO:2, and a light chain variable region comprising amino acids to 20 to 131 of SEQ ID NO:4.

11. The method of claim 1 , wherein the humanized antibody is vedolizumab.

12. A method for treating inflammatory bowel disease (IBD) in a human patient in need thereof, the method comprising

intravenously administering an initial dose of 300 mg of a humanized antibody having binding specificity for human a47 integrin to the human patient,

intravenously administering a second dose of 300 mg of the humanized antibody to the human patient 2 weeks after the initial dose,

intravenously administering a third dose of 300 mg of the humanized antibody to the human patient 6 weeks after the initial dose, and

subcutaneously administering a dose of 108 mg of the humanized antibody to the human patient via a prefilled syringe or an autoinjector every two weeks starting at 14 weeks after the initial dose,

wherein the IBD is ulcerative colitis or Crohn's disease,

wherein the treated human patient is in clinical remission, and

wherein the humanized antibody is an IgG1 isotype and comprises the following CDRs:

Light chain: CDR1 SEQ ID NO: 11

CDR2 SEQ ID NO: 12

CDR3 SEQ ID NO: 13

Heavy chain: CDR1 SEQ ID NO: 8

CDR2 SEQ ID NO: 9

CDR3 SEQ ID NO: 10.

13. The method of claim 12 , wherein the dose of 108 mg is self-administered by the human patient.

14. The method of claim 12 , wherein the humanized antibody comprises a heavy chain variable region that is at least 95% identical to amino acids 20 to 140 of SEQ ID NO:2, and a light chain variable region that is at least 95% identical to amino acids 20 to 131 of SEQ ID NO:4.

15. The method of claim 12 , wherein the humanized antibody comprises a heavy chain variable region comprising amino acids 20 to 140 of SEQ ID NO:2, and a light chain variable region comprising amino acids to 20 to 131 of SEQ ID NO:4.

16. The method of claim 12 , wherein the humanized antibody is vedolizumab.

17. The method of claim 12 , wherein the human patient had a lack of an adequate response with, loss of response to, or was intolerant to treatment with a tumor necrosis factor-alpha antagonist.

18. The method of claim 12 , wherein the treated human patient having ulcerative colitis has mucosal healing.

19. The method of claim 16 , wherein the treated human patient having ulcerative colitis has mucosal healing.

20. The method of claim 12 , wherein the Crohn's disease is moderately to severely active Crohn's disease.

21. The method of claim 12 , wherein the ulcerative colitis is moderately to severely active ulcerative colitis.

22. The method of claim 1 , wherein the human patient has Crohn's disease and has a clinical response for at least 6 months.

23. The method of claim 1 , wherein the human patient has Crohn's disease and has a clinical response for at least 9 months.

24. The method of claim 1 , wherein the human patient has ulcerative colitis and has a clinical response for at least 6 months.

25. The method of claim 1 , wherein the human patient has ulcerative colitis and has a clinical response for at least 9 months.

26. The method of claim 12 , wherein the human patient has Crohn's disease and has a clinical response for at least 6 months.

27. The method of claim 12 , wherein the human patient has Crohn's disease and has a clinical response for at least 9 months.

28. The method of claim 12 , wherein the human patient has ulcerative colitis and has a clinical response for at least 6 months.

29. The method of claim 12 , wherein the human patient has ulcerative colitis and has a clinical response for at least 9 months.

30. The method of claim 12 , wherein the treated human patient reduces or discontinues use of corticosteroids.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2024
From: TAKEDA PHARMACEUTICAL COMPANY LIMITED
To: MILLENNIUM PHARMACEUTICALS, INC.
Reel/Frame 068083/0220 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2024
From: DILUZIO, WILLOW; NGUYEN, PHOUNG M.; VARGA, CSANAD M.; PALANIAPPAN, VAITHIANATHAN; BROWN, JASON; FOX, IRVING H.; SCHOLZ, CATHERINE; ROSARIO, MARIA
To: MILLENNIUM PHARMACEUTICALS, INC.
Reel/Frame 068083/0099 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2024
From: MILLENNIUM PHARMACEUTICALS, INC.
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 068083/0323 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2024
From: JENKINS, HELEN
To: TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTRE (EUROPE) LTD.
Reel/Frame 068083/0156 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2024
From: TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTRE (EUROPE) LTD.
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 068083/0212 →
Continuity (6)
Division 16787521 · Feb 11, 2020
Continuation 15983791 · May 18, 2018
Continuation 14114835
Provisional Application 61544054 · Oct 6, 2011
Provisional Application 61481522 · May 2, 2011
Related Publication 20210340261A1 · Nov 4, 2021
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