Human-derived bacteria that induce proliferation or accumulation of regulatory T cells

• US 10,238,694 B2
• Filed: 11/29/2012
• Issued: 03/26/2019
• Est. Priority Date: 12/01/2011
• Status: Active Grant

• Current Assignee: School Corporation Azabu Veterinary Medicine Educational Institution, University of Tokyo
• Original Assignee: School Corporation Azabu Veterinary Medicine Educational Institution, University of Tokyo
• Inventors: Honda, Kenya, Atarashi, Koji, Tanoue, Takeshi, Hattori, Masahira, Morita, Hidetoshi
• Primary Examiner(s): Minnifield, Nita M.
• Application Number:
  US14/362,097
• Publication Number:
  US 20140341921A1
• Time in Patent Office: 2,308 Days
• Field of Search: None
• CPC Class Codes: A61K 2035/11 Medicinal preparations comprising living procariotic cells
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 35/742 Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
• CPC Class Codes: A61K 35/745 Bifidobacteria
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 33/00 Antiparasitic agents
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: C12N 1/20 Bacteria; Culture media therefor
• CPC Class Codes: C12N 1/205 Bacterial isolates
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: C12Q 1/689 for bacteria
• CPC Class Codes: C12Q 2600/156 Polymorphic or mutational markers
• CPC Class Codes: C12R 2001/145 Clostridium
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Species of human-derived bacteria belonging to the Clostridia class have been shown to induce accumulation of regulatory T cells (Treg cells) in the colon and suppress immune functions. Pharmaceutical compositions containing these bacteria can be used to prevent and treat immune-mediated diseases such as autoimmune diseases.

Claims

1. A method of treating, aiding in treating, reducing the severity of at least one disease selected from an autoimmune disease, an inflammatory disease, an allergic disease, and an infectious disease in an individual in need thereof,

the method comprising administering to the individual a purified composition comprising five or more human-derived bacteria,

wherein one or more bacteria belongs to Clostridium Cluster XVIII and one or more bacteria belongs to Clostridium Cluster IV or Clostridium Cluster XIVa.

2. The method of claim 1, wherein the composition comprises one or more bacteria belonging to Clostridium Cluster IV and one or more bacteria belonging to Clostridium Cluster XIVa.

3. The method of claim 1, wherein the composition comprises bacteria selected from the group consisting of:

Clostridium saccharogumia, Clostridium ramosum JCM 1298, Clostridium ramosum, Flavonifractor plautii, Pseudoflavonifractor capillosus ATCC 29799, Clostridium hathewayi, Clostridium saccharolyticum WM1, Bacteroides sp. MANG, Clostridium saccharolyticum, Clostridium scindens, Lachnospiraceae bacterium 5_1_57FAA, Lachnospiraceae bacterium 6_1_63FAA, Clostridium sp. 14616, Clostridium bolteae ATCC BAA-613, cf. Clostridium sp. MLG055, Erysipelotrichaceae bacterium 2_2_44A, Clostridium indolis, Anaerostipes caccae, Clostridium bolteae, Lachnospiraceae bacterium DJF_VP30, Lachnospiraceae bacterium 3_1_57FAA_CT1, Anaerotruncus colihominis, Anaerotruncus colihominis DSM 17241, Ruminococcus sp. ID8, Lachnospiraceae bacterium 2_1_46FAA, Clostridium lavalense, Clostridium asparagiforme DSM 15981, Clostridium symbiosum, Clostridium symbiosum WAL-14163, Eubacterium contortum, Clostridium sp. D5, Oscillospiraceae bacterium NML 061048, Oscillibacter valericigenes, Lachnospiraceae bacterium A4, Clostridium sp. 316002/08, Clostridiales bacterium 1_7_47FAA, Blautia cocoides, and Anaerostipes caccae DSM 14662.

4. The method of claim 1, wherein the composition comprises bacteria that contain DNA comprising a nucleotide sequence that has at least 95% homology with a DNA sequence designated herein as OTU136 (SEQ ID NO:

19);

OTU46 (SEQ ID NO;

20);

OTU221 (SEQ ID NO;

21);

OTU9 (SEQ ID NO;

22);

OTU296 (SEQ ID NO;

23);

OTU21 (SEQ ID NO;

24);

OTU166 (SEQ ID NO;

25);

OTU73 (SEQ ID NO;

26);

OTU174 (SEQ ID NO;

27);

OTU14 (SEQ ID NO;

28);

OTU55 (SEQ ID NO;

29);

OTU337 (SEQ ID NO;

30);

OTU314 (SEQ ID NO;

31);

OTU195 (SEQ ID NO;

32);

OTU306 (SEQ ID NO;

33);

OTU87 (SEQ ID NO;

34);

OTU86 (SEQ ID NO;

35);

OTU152 (SEQ ID NO;

36);

OTU253 (SEQ ID NO;

37);

OTU259 (SEQ ID NO;

38);

OTU281 (SEQ ID NO;

39);

OTU288 (SEQ ID NO;

40);

OTU334 (SEQ ID NO;

41);

OTU359 (SEQ ID NO;

42);

OTU362 (SEQ ID NO;

43);

or OTU367 (SEQ ID NO;

44);

or

bacteria that contain DNA comprising a nucleotide sequence that has at least 95% homology with DNA of one or more of the following bacteria;

Clostridium saccharogumia, Clostridium ramosum JCM 1298, Clostridium ramosum, Flavonifractor plautii, Pseudoflavonifractor capillosus ATCC 29799, Clostridium hathewayi, Clostridium saccharolyticum WM1, Bacteroides sp. MANG, Clostridium saccharolyticum, Clostridium scindens, Lachnospiraceae bacterium 5_1_57FAA, Lachnospiraceae bacterium 6_1_63FAA, Clostridium sp. 14616, Clostridium bolteae ATCC BAA-613, cf. Clostridium sp. MLG055, Erysipelotrichaceae bacterium 2_2_44A, Clostridium indolis, Anaerostipes caccae, Clostridium bolteae, Lachnospiraceae bacterium DJF_VP30, Lachnospiraceae bacterium 3_1_57FAA_CT1, Anaerotruncus colihominis, Anaerotruncus colihominis DSM 17241, Ruminococcus sp. ID8, Lachnospiraceae bacterium 2_1_46FAA, Clostridium lavalense, Clostridium asparagiforme DSM 15981, Clostridium symbiosum, Clostridium symbiosum WAL-14163, Eubacterium contortum, Clostridium sp. D5, Oscillospiraceae bacterium NML 061048, Oscillibacter valericigenes, Lachnospiraceae bacterium A4, Clostridium sp. 316002/08, Clostridiales bacterium 1_7_47FAA, Blautia cocoides, or Anaerostipes caccae DSM 14662.

5. The method of claim 1, wherein the composition comprises a pharmaceutically acceptable component.

6. The method of claim 2, wherein the composition comprises a pharmaceutically acceptable component.

7. The method of claim 3, wherein the composition comprises a pharmaceutically acceptable component.

8. The method of claim 4, wherein the composition comprises a pharmaceutically acceptable component.