COMPOSITIONS COMPRISING BACTERIAL STRAINS

• US 20190015459A1
• Filed: 07/19/2018
• Published: 01/17/2019
• Est. Priority Date: 06/15/2015
• Status: Active Grant

• Current Assignee: CJ Bioscience Incorporated
• Original Assignee: 4D Pharma Research Limited (4D Pharma PLC)
• Inventors: GRANT, George, PATTERSON, Angela Margaret, MULDER, Imke, MCCLUSKEY, Seanin, RAFTIS, Emma
• Granted Patent: US 10,391,130 B2
• Time in Patent Office: Days
• CPC Class Codes: A23C 9/12 Fermented milk preparations; Treatment using microorganisms or enzymes
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A61K 2039/52 Bacterial cells; Fungal cells; Protozoal cells
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2039/58 raising an immune response against a target which is not the antigen used for immunisation
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 39/0216 Bacteriodetes, e.g. Bacteroides, Ornithobacter, Porphyromonas
• CPC Class Codes: A61K 9/19 lyophilised , i.e. freeze-dried, solutions or dispersions lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/28 : for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 27/02 : Ophthalmic agents
• 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 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 35/04 : specific for metastasis
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• 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: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/00 : Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: C12N 1/205 : Bacterial isolates
• CPC Class Codes: C12R 2001/01 : Bacteria or Actinomycetales ; using bacteria or Actinomycetales
• 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

The invention provides compositions comprising bacterial strains for treating and preventing inflammatory and autoimmune diseases.

Claims

1-50. -50. (canceled)

51. A method of reducing inflammation associated with Th17 cell differentiation in a subject having a disorder mediated by the Th17 pathway, comprising administering to the subject a pharmaceutical composition that comprises a bacteria strain of the genus Bacteroides, wherein the administering reduces inflammation associated with Th17 cell differentiation in the subject, and

wherein the bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has at least 95% sequence identity to the polynucleotide sequence of SEQ ID NO:

4, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62.

52. The method of claim 51, wherein the administering decreases production of at least one pro-inflammatory cytokine in the subject.

53. The method of claim 52, wherein the at least one pro-inflammatory cytokine comprises an IL-17 cytokine selected from the group consisting of:

IL-17A, IL-17B, IL-17C, IL-17D, IL-17E, and IL-17F.

54. The method of claim 52, wherein the at least one pro-inflammatory cytokine comprises a cytokine selected from the group consisting of:

IFN-γ

, IL-1β

, RANTES, MIP-1α

, IL-8, and IL-6.

55. The method of claim 51, wherein the disorder mediated by the Th17 pathway is selected from the group consisting of:

uveitis, multiple sclerosis, arthritis, neuromyelitis optica, psoriasis, systemic lupus erythematosus, an inflammatory bowel disease, celiac disease, asthma, chronic obstructive pulmonary disease (COPD), scleritis, vasculitis, Behcet'"'"'s disease, atherosclerosis, atopic dermatitis, emphysema, periodontitis, allergic rhinitis, and allograft rejection.

56. The method of claim 51, wherein the disorder mediated by the Th17 pathway is multiple sclerosis.

57. The method of claim 51, wherein the disorder mediated by the Th17 pathway is asthma.

58. The method of claim 51, wherein the disorder mediated by the Th17 pathway is arthritis.

59. The method of claim 58, wherein the arthritis is selected from the group consisting of rheumatoid arthritis, osteoarthritis, psoriatic arthritis, spondyloarthritis, ankylosing spondylitis, and juvenile idiopathic arthritis, and wherein the method reduces joint swelling.

60. The method of claim 51, wherein the administering comprises oral, rectal, nasal, buccal, sublingual, intraperitoneal, or subcutaneous administration.

61. The method of claim 51, wherein the bacteria strain comprises the polynucleotide sequence of SEQ ID NO:

4.

62. The method of claim 51, wherein the bacteria strain is strain 675 deposited under accession number NCIMB 42408

63. The method of claim 51, wherein the pharmaceutical composition comprises a single therapeutically active bacteria strain.

64. The method of claim 51, wherein the bacteria strain is live.

65. The method of claim 51, wherein the bacteria strain is viable and capable of partially or totally colonizing a gastrointestinal tract of the subject.

66. A method of treating multiple sclerosis in a subject, comprising administering to the subject a pharmaceutical composition that comprises a live, viable bacteria strain of the genus Bacteroides.

67. The method of claim 66, wherein the pharmaceutical composition comprises from about 1×

10³ to about 1×

10¹¹ colony forming units (CFU)/g the bacteria strain with respect to total weight of the pharmaceutical composition

68. The method of claim 66, wherein the bacteria strain comprises a polynucleotide sequence of a 16S rRNA gene that has at least 95% sequence identity to the polynucleotide sequence of SEQ ID NO:

4, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12, a gap extension penalty of 2, and a Blocks Substitution Matrix (BLOSUM) of 62.

69. The method of claim 68, wherein the bacteria strain comprises the polynucleotide sequence of SEQ ID NO:

4.

70. The method of claim 66, wherein the bacteria strain is strain 675 deposited under accession number NCIMB 42408.

71. A method of treating asthma in a subject, comprising administering to the subject a pharmaceutical composition that comprises a live, viable bacteria strain of the genus Bacteroides.