IP Library Granted Patent US 11,090,343
Granted Patent B2
US 11,090,343 · App. 16/780,116 · Granted Aug 17, 2021

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 11,090,343
App. No.
16/780,116
Granted
Aug 17, 2021
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 (39)

1. A pharmaceutical composition, comprising one or more purified live bacterial strains belonging to Clostridium clusters IV or XIVa,

wherein the one or more bacterial strains induces proliferation and/or accumulation of regulatory T cells,

wherein the one or more 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 one or more bacterial strains belonging to Clostridium clusters IV or XIVa comprises one or more bacterial strains belonging to Clostridium cluster IV.

3. The pharmaceutical composition of claim 1 , wherein the one or more bacterial strains belonging to Clostridium clusters IV or XIVa comprises one or more bacterial strains belonging to Clostridium cluster XIVa.

4. 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.

5. The pharmaceutical composition of claim 1 , wherein at least one of the one or more bacterial strains is a spore forming bacteria.

6. The pharmaceutical composition of claim 1 , wherein at least one of the one or more bacterial strains is in the form of spores.

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

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

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

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

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

12. The method of claim 11 , 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.

13. The method of claim 11 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, or Crohn's disease.

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

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

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

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

18. A pharmaceutical composition, comprising one or more purified bacterial strains belonging to Clostridium clusters IV or XIVa,

wherein the one or more bacterial strains induces proliferation and/or accumulation of regulatory T cells,

wherein the one or more bacterial strains are isolated from a human, and

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

19. The pharmaceutical composition of claim 18 , wherein the one or more bacterial strains belonging to Clostridium clusters IV or XIVa comprises one or more bacterial strains belonging to Clostridium cluster IV.

20. The pharmaceutical composition of claim 18 , wherein the one or more bacterial strains belonging to Clostridium clusters IV or XIVa comprises one or more bacterial strains belonging to Clostridium cluster XIVa.

21. The pharmaceutical composition of claim 18 , 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 18 , wherein at least one of the one or more bacterial strains is a spore forming bacteria.

23. The pharmaceutical composition of claim 18 , wherein at least one of the one or more bacterial strains is in the form of spores.

24. The pharmaceutical composition of claim 18 , wherein the pharmaceutical composition further comprises a pharmacologically acceptable excipient.

25. The pharmaceutical composition of claim 18 , wherein the pharmaceutical composition is formulated for oral administration.

26. The pharmaceutical composition of claim 18 , wherein the pharmaceutical composition is in the form of a capsule.

27. A method of treating a human subject having an autoimmune disease, the method comprising administering to the human subject the composition of claim 18 .

28. The method of claim 27 , 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.

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

30. A method of treating a human subject having an allergic disease, the method comprising administering to the human subject the composition of claim 18 .

31. The method of claim 30 , wherein the allergic disease is food allergy.

32. A method of treating a human subject having an infectious disease, the method comprising administering to the human subject the composition of claim 18 .

33. The method of claim 32 , wherein the infectious disease is Clostridium difficile infection.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 12, 2020
From: HONDA, KENYA; ATARASHI, KOJI; ITOH, KIKUJI; TANOUE, TAKESHI
To: THE UNIVERSITY OF TOKYO
Reel/Frame 051795/0169 →
Priority Claims (2)
JP 2010-129134 · Jun 4, 2010 · national
WO PCT/JP2010/071746 · Dec 3, 2010 · international
Continuity (9)
Continuation 16425030 · May 29, 2019
Continuation 16389380 · Apr 19, 2019
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 20200246399A1 · Aug 6, 2020
Cited By (3)
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