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

• US 9,649,345 B2
• Filed: 02/09/2016
• Issued: 05/16/2017
• 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: Morita, Hidetoshi, Honda, Kenya, Atarashi, Koji, Tanoue, Takeshi, Hattori, Masahira
• Primary Examiner(s): Minnifield, Nita M
• Application Number:
  US15/019,101
• Publication Number:
  US 20160193257A1
• Time in Patent Office: 462 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 autoimmune disease in a subject, the method comprising

administering a pharmaceutical composition comprising a purified bacterial mixture consisting of bacteria comprising 16S rDNA sequences of at least 95% homology to SEQ ID NO:

19, SEQ ID NO;

20, SEQ ID NO;

21, SEQ ID NO;

22, SEQ ID NO;

24, SEQ ID NO;

25, SEQ ID NO;

26, SEQ ID NO;

27, SEQ ID NO;

30, SEQ ID NO;

31, SEQ ID NO;

32, SEQ ID NO;

33, SEQ ID NO;

34, SEQ ID NO;

39, SEQ ID NO;

40, SEQ ID NO;

41, and SEQ ID NO;

42, to the subject in an amount sufficient to treat autoimmune disease.

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

3. The method of claim 2, wherein the autoimmune disease is inflammatory bowel disease (IBD), ulcerative colitis, pouchitis, or Crohn'"'"'s disease.

4. The method of claim 1, wherein the bacteria are human-derived bacteria.

5. The method of claim 1, wherein the bacteria are isolated from a chloroform-treated fecal sample.

6. The method of claim 1, wherein the bacteria are isolated from a heat-treated fecal sample.

7. The method of claim 1, wherein at least a portion of the bacteria are in spore-form.

8. The method of claim 1, wherein the composition further comprises a pharmaceutically acceptable excipient.

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