Composition for inducing proliferation or accumulation of regulatory t cells

Patent metadata

Field	Value
Publication number	US-2020246399-A1
Application number	US-202016780116-A
Country	US
Kind code	A1
Filing date	Feb 3, 2020
Priority date	Jun 4, 2010
Publication date	Aug 6, 2020
Grant date	—

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.

First claim

1 .- 19 . (canceled)

20 . 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.

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

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

23 . The pharmaceutical composition of claim 20 , 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.

24 . The pharmaceutical composition of claim 20 , wherein at least one of the one or more bacterial strains is a spore forming bacteria.

25 . The pharmaceutical composition of claim 20 , wherein at least one of the one or more bacterial strains is in the form of spores.

26 . The pharmaceutical composition of claim 20 , wherein the pharmaceutical composition further comprises a pharmacologically acceptable excipient.

27 . The pharmaceutical composition of claim 20 , wherein the pharmaceutical composition is formulated for oral administration.

28 . The pharmaceutical composition of claim 20 , wherein the pharmaceutical composition further comprises a pH sensitive composition comprising one or more enteric polymers.

29 . The pharmaceutical composition of claim 20 , wherein the pharmaceutical composition is in the form of a capsule.

30 . A method of treating a human subject having an autoimmune disease, the method comprising administering to the human subject the composition of claim 20 .

31 . The method of claim 30 , 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.

32 . The method of claim 30 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, or Crohn's disease.

33 . A method of treating a human subject having an allergic disease, the method comprising administering to the human subject the composition of claim 20 .

34 . The method of claim 33 , wherein the allergic disease is food allergy.

35 . A method of treating a human subject having an infectious disease, the method comprising administering to the human subject the composition of claim 20 .

36 . The method of claim 35 , wherein the infectious disease is Clostridium difficile infection.

37 . 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.

38 . The pharmaceutical composition of claim 37 , wherein the one or more bacterial strains belonging to Clostridium clusters IV or XIVa comprises one or more strains belonging to Clostridium cluster IV.

39 . The pharmaceutical composition of claim 37 , wherein the one or more bacterial strains belonging to Clostridium clusters IV or XIVa comprises one or more strains belonging to Clostridium cluster XIVa.

40 . The pharmaceutical composition of claim 37 , 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.

41 . The pharmaceutical composition of claim 37 , wherein at least one of the one or more bacterial strains is a spore forming bacteria.

42 . The pharmaceutical composition of claim 37 , wherein at least one of the one or more bacterial strains is in the form of spores.

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

44 . The pharmaceutical composition of claim 37 , wherein the pharmaceutical composition is formulated for oral administration.

45 . The pharmaceutical composition of claim 37 , wherein the pharmaceutical composition is in the form of a capsule.

46 . A method of treating a human subject having an autoimmune disease, the method comprising administering to the human subject the composition of claim 37 .

47 . The method of claim 46 , 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.

48 . The method of claim 46 , wherein the autoimmune disease is organ transplant rejection, inflammatory bowel disease (IBD), ulcerative colitis, or Crohn's disease.

49 . A method of treating a human subject having an allergic disease, the method comprising administering to the human subject the composition of claim 37 .

50 . The method of claim 49 , wherein the allergic disease is food allergy.

51 . A method of treating a human subject having an infectious disease, the method comprising administering to the human subject the composition of claim 37 .

52 . The method of claim 51 , wherein the infectious disease is Clostridium difficile infection.

Assignees

• Univ Tokyo

Inventors

• Honda Kenya
• Atarashi Koji
• Itoh Kikuji
• Tanoue Takeshi

Classifications

• A61P37/06

  Immunosuppressants, e.g. drugs for graft rejection · CPC title

• A01K2227/105

  Murine · CPC title

• A61P1/04

  for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants · CPC title

• A01K2267/0325

  Animal model for autoimmune diseases · CPC title

• G01N2333/33

  from Clostridium (G) · CPC title