Composition for inducing proliferation or accumulation of regulatory t cells

Patent metadata

Field	Value
Publication number	US-2025375488-A1
Application number	US-202519299447-A
Country	US
Kind code	A1
Filing date	Aug 14, 2025
Priority date	Jun 4, 2010
Publication date	Dec 11, 2025
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 . A pharmaceutical composition, comprising six or more live bacterial strains belonging to Clostridium clusters IV and/or XIVa, wherein the six or more bacterial strains are spore-forming bacterial strains, wherein the six or more bacterial strains induce proliferation and/or accumulation of regulatory T cells, wherein at least one of the bacterial strains is a human commensal bacterial strain, and wherein the pharmaceutical composition is formulated for oral administration and delivery to the intestines.

2 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises a severely decreased level of non-spore-forming bacteria relative to human stool.

3 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition comprises no non-spore-forming bacteria.

4 . The pharmaceutical composition of claim 1 , wherein the regulatory T cells are Foxp3 + regulatory T cells.

5 . The pharmaceutical composition of claim 4 , wherein the pharmaceutical composition is in the form of a capsule.

6 . The pharmaceutical composition of claim 5 , wherein the pharmaceutical composition is formulated for delivery to the colon.

7 . The pharmaceutical composition of claim 5 , wherein the capsule comprises a hydrogel.

8 . The pharmaceutical composition of claim 6 , wherein the hydrogel comprises a cellulose-based polymer.

9 . The pharmaceutical composition of claim 6 , wherein the capsule comprises a pH-sensitive composition comprising one or more enteric polymers.

10 . The pharmaceutical composition of claim 4 , wherein substantially all spore-forming bacteria of the pharmaceutical composition are in spore form.

11 . A method of inducing proliferation and/or accumulation of regulatory T cells in the colon of a human subject, the method comprising administering to the human subject a pharmaceutical composition comprising six or more live bacterial strains belonging to Clostridium clusters IV and/or XIVa, wherein the six or more bacterial strains are spore-forming bacterial strains, wherein at least one of the bacterial strains is a human commensal bacterial strain, and wherein the pharmaceutical composition is formulated for oral administration and delivery to the intestines.

12 . The method of claim 11 , wherein the pharmaceutical composition comprises a severely decreased level of non-spore-forming bacteria relative to human stool.

13 . The method of claim 12 , wherein the pharmaceutical composition comprises no non-spore-forming bacteria.

14 . The method of claim 11 , wherein the regulatory T cells are Foxp3 + regulatory T cells.

15 . The method of claim 14 , wherein the pharmaceutical composition is administered after antibiotic treatment.

16 . The method of claim 15 , wherein the pharmaceutical composition is in the form of a capsule.

17 . The method of claim 16 , wherein the pharmaceutical composition is formulated for delivery to the colon.

18 . The method of claim 16 , wherein the capsule comprises a hydrogel.

19 . The method of claim 17 , wherein the hydrogel comprises a cellulose-based polymer.

20 . The method of claim 17 , wherein the capsule comprises a pH-sensitive composition comprising one or more enteric polymers.

21 . The method of claim 15 , wherein the method reduces the likelihood of a Clostridium difficile infection in the subject.

22 . The method of claim 21 , wherein the C. difficile infection is a recurrence of C. difficile infection.

23 . The method of claim 14 . wherein substantially all spore-forming bacteria of the pharmaceutical composition are in spore form.

Assignees

• Univ Tokyo

Inventors

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

Classifications

• A61K9/48

  Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} · CPC title

• C12Q2600/158

  Expression markers · CPC title

• A61K2039/57

  characterised by the type of response, e.g. Th1, Th2 · CPC title

• A61K2039/55594

  from bacteria · CPC title

• A61K2039/542

  oral/gastrointestinal · CPC title