IP Library Granted Patent US 10,588,925
Granted Patent B2
US 10,588,925 · App. 16/389,380 · Granted Mar 17, 2020

Composition for inducing proliferation or accumulation of regulatory T cells

Inventors: Kenya Honda (Tokyo, JP); Koji Atarashi (Tokyo, JP); Kikuji Itoh (Tokyo, JP); Takeshi Tanoue (Tokyo, JP)
Assignee: The University of Tokyo
A61K35/742A01K67/0275A61K9/0053A61K9/48A61K35/74A61K39/0008A61K39/08A61K39/39A61K45/00A61K45/06C12Q1/689G01N33/505A01K2267/0325A61K35/00A61K2039/52A61K2039/542A61K2039/55594A61K2039/57C12Q2600/158G01N2333/33G01N2500/10
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Quick Facts
Patent No.
US 10,588,925
App. No.
16/389,380
Granted
Mar 17, 2020
Kind
B2
Abstract

It was found that bacteria belonging to the genus Clostridium induce accumulation of regulatory T cells (Treg cells) in the colon. Moreover, the present inventors found that regulatory T cells (Treg cells) induced by from these bacteria suppressed proliferation of effector T-cells. From these findings, the present inventors found that the use of bacteria belonging to the genus Clostridium or a physiologically active substance derived therefrom made it possible to induce proliferation or accumulation of regulatory T cells (Treg cells), and further to suppress immune functions.

Claims (55)

1. A pharmaceutical composition, comprising a purified bacterial mixture of at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa,

wherein the bacterial mixture induces proliferation and/or accumulation of regulatory T cells,

wherein the bacterial strains are human commensal bacteria, and

wherein the pharmaceutical composition is formulated for delivery to the intestine.

2. The pharmaceutical composition of claim 1 , wherein the at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa comprise two or more strains belonging to Clostridium cluster IV.

3. The pharmaceutical composition of claim 1 , wherein the at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa comprise two or more strains belonging to Clostridium cluster XIVa.

4. The pharmaceutical composition of claim 1 , wherein the at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa comprise one or more strains belonging to Clostridium cluster IV and one or more strains belonging to Clostridium cluster XIVa.

5. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises one or more bacterial strains belonging to a Clostridium cluster other than Clostridium cluster IV or Clostridium cluster XIVa.

6. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises a pharmacologically acceptable excipient.

7. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for oral administration.

8. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises a pH sensitive composition comprising one or more enteric polymers.

9. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is in the form of a capsule.

10. A method of treating a human subject having an autoimmune disease, the method comprising administering the composition of claim 1 .

11. The method of claim 10 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, sprue, rheumatoid arthritis, Type 1 diabetes, graft versus host disease, or multiple sclerosis.

12. The method of claim 10 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, or Crohn's disease.

13. A method of treating a human subject having an allergic disease, the method comprising administering the composition of claim 1 .

14. The method of claim 13 , wherein the allergic disease is food allergy.

15. A method of treating a human subject having an infectious disease, the method comprising administering the composition of claim 1 .

16. The method of claim 14 , wherein the infectious disease is Clostridium difficile infection.

17. A pharmaceutical composition, comprising a purified bacterial mixture of at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa,

wherein the bacterial mixture induces proliferation and/or accumulation of regulatory T cells,

wherein the bacterial strains are isolated from a human, and

wherein the pharmaceutical composition further comprises a pH sensitive composition comprising one or more enteric polymers.

18. The pharmaceutical composition of claim 17 , wherein the at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa comprise two or more strains belonging to Clostridium cluster IV.

19. The pharmaceutical composition of claim 17 , wherein the at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa comprise two or more strains belonging to Clostridium cluster XIVa.

20. The pharmaceutical composition of claim 17 , wherein the at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa comprise one or more strains belonging to Clostridium cluster IV and one or more strains belonging to Clostridium cluster XIVa.

21. The pharmaceutical composition of claim 17 , wherein the pharmaceutical composition further comprises one or more bacterial strains belonging to a Clostridium cluster other than Clostridium cluster IV or Clostridium cluster XIVa.

22. The pharmaceutical composition of claim 17 , wherein the pharmaceutical composition further comprises a pharmacologically acceptable excipient.

23. The pharmaceutical composition of claim 17 , wherein the pharmaceutical composition is formulated for oral administration.

24. The pharmaceutical composition of claim 17 , wherein the pharmaceutical composition is in the form of a capsule.

25. A method of treating a human subject having an autoimmune disease, the method comprising administering the composition of claim 17 .

26. The method of claim 25 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, sprue, rheumatoid arthritis, Type 1 diabetes, graft versus host disease, or multiple sclerosis.

27. The method of claim 25 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, or Crohn's disease.

28. A method of treating a human subject having an allergic disease, the method comprising administering the composition of claim 17 .

29. The method of claim 28 , wherein the allergic disease is food allergy.

30. A method of treating a human subject having an infectious disease, the method comprising administering the composition of claim 17 .

31. The method of claim 30 , wherein the infectious disease is Clostridium difficile infection.

32. A pharmaceutical composition, comprising a purified bacterial mixture of at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa,

wherein the bacterial mixture induces proliferation and/or accumulation of regulatory T cells,

wherein the bacterial strains are human commensal bacteria, and

wherein the pharmaceutical composition further comprises a pH sensitive composition comprising one or more enteric polymers.

33. The pharmaceutical composition of claim 32 , wherein the at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa comprise two or more strains belonging to Clostridium cluster IV.

34. The pharmaceutical composition of claim 32 , wherein the at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa comprise two or more strains belonging to Clostridium cluster XIVa.

35. The pharmaceutical composition of claim 32 , wherein the at least two live bacterial strains belonging to Clostridium clusters IV and/or XIVa comprise one or more strains belonging to Clostridium cluster IV and one or more strains belonging to Clostridium cluster XIVa.

36. The pharmaceutical composition of claim 32 , wherein the pharmaceutical composition further comprises one or more bacterial strains belonging to a Clostridium cluster other than Clostridium cluster IV or Clostridium cluster XIVa.

37. The pharmaceutical composition of claim 32 , wherein the pharmaceutical composition further comprises a pharmacologically acceptable excipient.

38. The pharmaceutical composition of claim 32 , wherein the pharmaceutical composition is formulated for oral administration.

39. The pharmaceutical composition of claim 32 , wherein the pharmaceutical composition is in the form of a capsule.

40. A method of treating a human subject having an autoimmune disease, the method comprising administering the composition of claim 32 .

41. The method of claim 40 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, sprue, rheumatoid arthritis, Type 1 diabetes, graft versus host disease, or multiple sclerosis.

42. The method of claim 40 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, or Crohn's disease.

43. A method of treating a human subject having an allergic disease, the method comprising administering the composition of claim 32 .

44. The method of claim 43 , wherein the allergic disease is food allergy.

45. A method of treating a human subject having an infectious disease, the method comprising administering the composition of claim 32 .

46. The method of claim 45 , wherein the infectious disease is Clostridium difficile infection.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 11, 2019
From: HONDA, KENYA; ATARASHI, KOJI; ITOH, KIKUJI; TANOUE, TAKESHI
To: THE UNIVERSITY OF TOKYO
Reel/Frame 050339/0273 →
Priority Claims (2)
JP 2010-129134 · Jun 4, 2010 · national
WO PCT/JP2010/071746 · Dec 3, 2010 · international
Continuity (7)
Continuation 16171558 · Oct 26, 2018
Continuation 16117054 · Aug 30, 2018
Continuation 15730203 · Oct 11, 2017
Continuation 15216015 · Jul 21, 2016
Continuation 14492850 · Sep 22, 2014
Continuation 13701467
Related Publication 20190282634A1 · Sep 19, 2019
Cited By (3)
US 12,214,003 US 12,409,196 US 12,502,411