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1. (WO2016196605) TREATMENT OF CANCER BY MANIPULATION OF COMMENSAL MICROFLORA
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CLAIMS

We claim:

1. A method of treating or preventing cancer in a subject, comprising modulating levels of one or more commensal microbes within the subject to: (A) enhance an immune response by the subject, (B) inhibit the growth or spread of the cancer, (C) inhibit immune evasion by the cancer, and/or (D) enhance the efficacy of a therapeutic.

2. The method of claim 1, wherein the levels of one or more commensal microbes are modulated within the gut of the subject.

3. The method of claim 1, wherein modulating the levels of one or more commensal microbes comprises increasing and/or decreasing levels of one or more bacterial selected from the genera Adlercreutzia, Oscillopira, Mollicutes, Butyrivibrio, Bacteroides,

Clostridium, Fusobacterium, Eubacterium, Ruminococcus, Peptococcus, Peptostreptococcus, Bifidobacterium, Rikenella, Alistipes, Marinilabilia, Anaerostipes, Escherichia, and/or Lactobacillus.

4. The method of claim 1, wherein modulating the levels of one or more commensal microbes comprises administering a beneficial microbes to the subject.

5. The method of claim 4, wherein the beneficial microbes are bacteria.

6. The method of claim 5, wherein the bacteria are selected from the genera

Adlercreutzia, Oscillopira, Mollicutes, Butyrivibrio, Bacteroides, Clostridium,

Fusobacterium, Eubacterium, Ruminococcus, Peptococcus, Peptostreptococcus,

Bifidobacterium, Rikenella, Alistipes, Marinilabilia, Anaerostipes, Escherichia, and/or Lactobacillus.

7. The method of claim 6, wherein the bacteria are Bifidobacterium.

8. The method of claim 7, wherein the Bifidobacterium include bacteria selected from the group consisting of Bifidobacterium lactis, Bifidobacterium bifldium, Bifidobacterium longum, Bifidobacterium animalis, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium catenulatum, Bifidobacterium pseudocatenulatum, Bifidobacterium adolescentis , and Bifidobacterium angulatum.

9. The method of claim 4, wherein the beneficial microbes are administered as a probiotic composition or via microflora transplant from a donor.

10. The method of claim 1, wherein modulating the levels of one or more commensal microbes comprises administering one or more antimicrobials.

11. The method of claim 10, wherein the antimicrobial kills detrimental microbes.

12. The method of claim 1 1, wherein the antimicrobial is an antibiotic.

13. The method of claim 12, further comprising administration of beneficial microbes to the subject.

14. The method of claim 1, further comprising administering to the subject a cancer therapy.

15. The method of claim 14, wherein the modulating levels of one or more commensal microbes within the subject enhances an immune response by the subject and/or inhibits immune evasion by the cancer, and the cancer therapy is an immunotherapy.

16. The method of claim 15, wherein the immunotherapy comprises administration of anti-CTLA-4 antibodies and/or anti-PD-Ll or anti-PD-1 antibodies.

17. The method of claim 14, wherein the modulating levels of one or more commensal microbes within the subject enhance the efficacy of a therapeutic, and the cancer therapy is said therapeutic.

18. The method of claim 17, wherein said therapeutic comprises a chemotherapeutic.

19. The method of claim 1, further comprising testing the subject for immune evasion by the cancer.

20. The method of claim 1, further comprising surgical, radiation, and/or

chemotherapeutic cancer intervention.

21. A kit or composition comprising a beneficial commensal microbe and a cancer therapeutic, said composition or components of said kit formulated for therapeutic delivery to a subject.

22. A beneficial commensal microbe for use as a medicament in the treatment of cancer and/or inhibition of immune evasion.

23. A method of treating or preventing cancer in a subject comprising administering to the subject bacterial formulation comprising bacteria of the genera Bifidobacterium, Rikenella, Alistipes, Marinilabilia, or Anaerostipes .

24. The method of claim 23, wherein at least 50% of the bacteria in the bacterial formulation are of the genera Bifidobacterium, Rikenella, Alistipes, Marinilabilia, or Anaerostipes.

25. The method of claim 23, wherein at least 90% of the bacteria in the bacterial formulation are of the genera Bifidobacterium, Rikenella, Alistipes, Marinilabilia, or Anaerostipes.

26. The method of claim 23, wherein the bacterial formulation comprise bacteria of the genus Bifidobacterium.

27. The method of claim 26, wherein at least 50% of the bacteria in the bacterial formulation are of the genus Bifidobacterium.

28. The method of claim 26, wherein at least 90% of the bacteria in the bacterial formulation are of the genus Bifidobacterium.

29. The method of any one of claims 26 to 28, wherein the bacteria of genus

Bifidobacterium are selected from the group consisting of Bifidobacterium lactis,

Bifidobacterium bifidium, Bifidobacterium longum, Bifidobacterium animalis,

Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium catenulatum,

Bifidobacterium pseudocatenulatum, Bifidobacterium adolescentis , Bifidobacterium angulatum, Bifidobacterium asteroides, Bifidobacterium bourn, Bifidobacterium choerinum, Bifidobacterium coryneforme, Bifidobacterium cuniculi, Bifidobacterium denticolens, Bifidobacterium dentium, Bifidobacterium gallicum, Bifidobacterium gallinarum,

Bifidobacterium indicum, Bifidobacterium inopinatum, Bifidobacterium magnum,

Bifidobacterium merycicum, Bifidobacterium minimum, Bifidobacterium pseudolongum, Bifidobacterium pullorum, Bifidobacterium psychraerophilum, Bifidobacterium ruminantium, Bifidobacterium saeculare, Bifidobacterium scardovii, Bifidobacterium simiae,

Bifidobacterium subtile, Bifidobacterium therammcidophilum, Bifidobacterium

thermophilum, Bifidobacterium tsurumiense, Bifidobacterium urinalis, and Bifidobacterium sp.

30. The method of any one of claims 23 to 29, wherein the cancer is cancer is selected from the group consisting of acute nonlymphocytic leukemia, chronic lymphocytic leukemia, acute granulocytic leukemia, chronic granulocytic leukemia, acute promyelocytic leukemia, adult T-cell leukemia, aleukemic leukemia, a leukocythemic leukemia, basophilic leukemia, blast cell leukemia, bovine leukemia, chronic myelocytic leukemia, leukemia cutis, embryonal leukemia, eosinophilic leukemia, Gross' leukemia, Rieder cell leukemia,

Schilling's leukemia, stem cell leukemia, subleukemic leukemia, undifferentiated cell leukemia, hairy-cell leukemia, hemoblastic leukemia, hemocytoblastic leukemia, histiocytic leukemia, stem cell leukemia, acute monocytic leukemia, leukopenic leukemia, lymphatic leukemia, lymphoblastic leukemia, lymphocytic leukemia, lymphogenous leukemia, lymphoid leukemia, lymphosarcoma cell leukemia, mast cell leukemia, megakaryocytic leukemia, micromyeloblastic leukemia, monocytic leukemia, myeloblastic leukemia, myelocytic leukemia, myeloid granulocytic leukemia, myelomonocytic leukemia, Naegeli leukemia, plasma cell leukemia, plasmacytic leukemia, promyelocytic leukemia, acinar carcinoma, acinous carcinoma, adenocystic carcinoma, adenoid cystic carcinoma, carcinoma adenomatosum, carcinoma of adrenal cortex, alveolar carcinoma, alveolar cell carcinoma, basal cell carcinoma, carcinoma basocellulare, basaloid carcinoma, basosquamous cell carcinoma, bronchioalveolar carcinoma, bronchiolar carcinoma, bronchogenic carcinoma, cerebriform carcinoma, cholangiocellular carcinoma, chorionic carcinoma, colloid carcinoma, comedo carcinoma, corpus carcinoma, cribriform carcinoma, carcinoma en cuirasse, carcinoma cutaneum, cylindrical carcinoma, cylindrical cell carcinoma, duct carcinoma, carcinoma durum, embryonal carcinoma, encephaloid carcinoma, epiennoid carcinoma, carcinoma epitheliale adenoides, exophytic carcinoma, carcinoma ex ulcere, carcinoma fibrosum, gelatiniform carcinoma, gelatinous carcinoma, giant cell carcinoma, signet-ring cell carcinoma, carcinoma simplex, small-cell carcinoma, solanoid carcinoma, spheroidal cell carcinoma, spindle cell carcinoma, carcinoma spongiosum, squamous carcinoma, squamous cell carcinoma, string carcinoma, carcinoma telangiectaticum, carcinoma telangiectodes, transitional cell carcinoma, carcinoma tuberosum, tuberous carcinoma, verrucous carcinoma, carcinoma villosum, carcinoma gigantocellulare, glandular carcinoma, granulosa cell carcinoma, hair-matrix carcinoma, hematoid carcinoma, hepatocellular carcinoma, Hurthle cell carcinoma, hyaline carcinoma, hypemephroid carcinoma, infantile embryonal carcinoma, carcinoma in situ, intraepi dermal carcinoma, intraepithelial carcinoma, Krompecher's carcinoma, Kulchitzky-cell carcinoma, large-cell carcinoma, lenticular carcinoma, carcinoma lenticulare, lipomatous carcinoma,

lymphoepithelial carcinoma, carcinoma medullare, medullary carcinoma, melanotic carcinoma, carcinoma molle, mucinous carcinoma, carcinoma muciparum, carcinoma mucocellulare, mucoepidermoid carcinoma, carcinoma mucosum, mucous carcinoma, carcinoma myxomatodes, naspharyngeal carcinoma, oat cell carcinoma, carcinoma ossificans, osteoid carcinoma, papillary carcinoma, periportal carcinoma, preinvasive carcinoma, prickle cell carcinoma, pultaceous carcinoma, renal cell carcinoma of kidney, reserve cell carcinoma, carcinoma sarcomatodes, schneiderian carcinoma, scirrhous carcinoma, carcinoma scroti, chondrosarcoma, fibrosarcoma, lymphosarcoma,

melanosarcoma, myxosarcoma, osteosarcoma, endometrial sarcoma, stromal sarcoma, Ewing' s sarcoma, fascial sarcoma, fibroblastic sarcoma, giant cell sarcoma, Abemethy's sarcoma, adipose sarcoma, liposarcoma, alveolar soft part sarcoma, ameloblastic sarcoma, botryoid sarcoma, chloroma sarcoma, chorio carcinoma, embryonal sarcoma, Wilms' tumor sarcoma, granulocytic sarcoma, Hodgkin's sarcoma, idiopathic multiple pigmented hemorrhagic sarcoma, immunoblastic sarcoma of B cells, lymphoma, immunoblastic sarcoma of T-cells, Jensen's sarcoma, Kaposi's sarcoma, Kupffer cell sarcoma, angiosarcoma, leukosarcoma, malignant mesenchymoma sarcoma, parosteal sarcoma, reticulocytic sarcoma, Rous sarcoma, serocystic sarcoma, synovial sarcoma, telangiectaltic sarcoma, Hodgkin's Disease, Non- Hodgkin's Lymphoma, multiple myeloma, neuroblastoma, breast cancer, ovarian cancer, lung cancer, rhabdomyosarcoma, primary thrombocytosis, primary macroglobulinemia, small-cell lung tumors, primary brain tumors, stomach cancer, colon cancer, malignant pancreatic insulanoma, malignant carcinoid, premalignant skin lesions, testicular cancer, lymphomas, thyroid cancer, neuroblastoma, esophageal cancer, genitourinary tract cancer, malignant hypercalcemia, cervical cancer, endometrial cancer, adrenal cortical cancer, Harding-Passey melanoma, juvenile melanoma, lentigo maligna melanoma, malignant melanoma, acral-lentiginous melanoma, amelanotic melanoma, benign juvenile melanoma, Cloudman's melanoma, S91 melanoma, nodular melanoma subungal melanoma, and superficial spreading melanoma.

31. The method of any one of claims 23 to 30, wherein the subject is human.

32. The method of any one of claims 23 to 31, wherein the bacterial formulation is administered by oral administration, rectal administration, topical administration, inhalation or injection.

33. The method of claim 26, wherein the bacterial formulation is administered by oral administration.

34. The method of claim 27, wherein the bacterial formulation is a food product.

35. The method of any one of claims 23 to 34, wherein the bacterial formulation comprises at least about 5x106 CFU of bacteria.

36. The method of any one of claims 23 to 35, wherein the bacterial formulation is administered to the subject in two or more doses.

37. The method of claim 36, wherein the administration of at least two of the two or more doses are separated by at least 1 day.

38. The method of claim 37, wherein the administration of at least two of the two or more doses are separated by at least 1 week.

39. The method of any one of claims 23 to 38, further comprising administering to the subject an antibiotic.

40. The method of claim 39, wherein the antibiotic is administered to the subject before the bacterial formulation.

41. The method of claim 40, wherein the antibiotic is administered to the subject at least 1 day before the bacterial formulation is administered to the subject.

42. The method of any one of claims 23 to 42, further comprising administering to the subject an immune checkpoint inhibitor.

43. The method of claim 42, wherein the immune checkpoint inhibitor is a protein or polypeptide that specifically binds to an immune checkpoint protein.

44. The method of claim 43, wherein the immune checkpoint protein is selected from the group consisting of CTLA4, PD-1, PD-Ll, PD-L2, A2AR, B7-H3, B7-H4, BTLA, KIR, LAG3, TIM-3 or VISTA.

45. The method of claim 43 or 44, wherein the polypeptide or protein is an antibody or antigen-binding fragment thereof.

46. λ The method of claim 42, wherein the immune checkpoint inhibitor is an interfering nucleic acid molecule.

47. The method of claim 46, wherein the interfering nucleic acid molecule is an siRNA molecule, an shRNA molecule or an antisense RNA molecule.

48. The method of claim 42, wherein the immune checkpoint inhibitor is selected from the group consisting of nivolumab, pembrolizumab, pidilizumab, AMP-224, AMP-514, STI-A1110, TSR-042, RG-7446, BMS-936559, BMS-936558, MK-3475, CT 01 1, MPDL3280A, MEDI-4736, MSB-0020718C, AUR-012 and STI-A1010.

49. The method of any one of claims 42 to 48, wherein the immune checkpoint inhibitor is administered before the bacterial formulation.

50. The method of claim 49, wherein the immune checkpoint inhibitor is administered at least one day before the bacterial formulation.

51. The method of any one of claims 42 to 48, wherein the immune checkpoint is administered at about the same time as the bacterial formulation.

52. The method of claim 51 , wherein the immune checkpoint inhibitor is administered on the same day as the bacterial formulation.

53. The method of any one of claims 42 to 48, wherein the immune checkpoint inhibitor is administered after the bacterial formulation.

54. The method of claim 49, wherein the immune checkpoint inhibitor is administered at least one day after the bacterial formulation.

55. The method of any one of claims 42 to 54, wherein the immune checkpoint inhibitor is administered by injection.

56. The method of claim 55, wherein the injection is an intravenous, intramuscular, intratumoral or subcutaneous injection.

57. A method of treating cancer in a human subject comprising administering to the subject an immune checkpoint inhibitor and a bacterial formulation comprising bacteria of the genera Bifidobacterium.

58. The method of claim 57, wherein at least 50% of the bacteria in the bacterial formulation are of the genera Bifidobacterium.

59. The method of claim 57, wherein at least 90% of the bacteria in the bacterial formulation are of the genera Bifidobacterium.

60. The method of claim 57, wherein the bacteria of the genus Bifidobacterium comprise bacteria of the species Bifidobacterium lactis, Bifidobacterium bifidium, Bifidobacterium longum, Bifidobacterium animalis, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium catenulatum, Bifidobacterium pseudocatenulatum, Bifidobacterium adolescentis, Bifidobacterium angulatum, Bifidobacterium asteroides, Bifidobacterium boum, Bifidobacterium choerinum, Bifidobacterium coryneforme, Bifidobacterium cuniculi, Bifidobacterium denticolens, Bifidobacterium dentium, Bifidobacterium gallicum, Bifidobacterium gallinarum, Bifidobacterium indicum, Bifidobacterium inopinatum, Bifidobacterium magnum, Bifidobacterium merycicum, Bifidobacterium minimum, Bifidobacterium pseudolongum, Bifidobacterium pullorum, Bifidobacterium psychraerophilum, Bifidobacterium ruminantium, Bifidobacterium saeculare, Bifidobacterium scardovii, Bifidobacterium simiae, Bifidobacterium subtile, Bifidobacterium therammcidophilum, Bifidobacterium thermophilum, Bifidobacterium tsurumiense, Bifidobacterium urinalis or Bifidobacterium sp.

61. The method of claim 57, wherein the bacterial formulation is administered by oral administration or rectal administration.

62. The method of claim 61, wherein the bacterial formulation is administered by oral administration.

63. The method of claim 57, wherein the bacterial formulation comprises at least 5xl06 CFU of bacteria of the genera Bifidobacterium.

64. The method of claim 1, wherein the bacterial formulation is administered to the subject in two or more doses.

65. The method of claim 64, wherein the administration of the two or more doses are separated by at least 1 week.

66. The method of claim 57, further comprising administering to the subject an antibiotic prior to the administration of the bacterial formulation.

67. The method of claim 66, wherein the antibiotic is administered to the subject at least 1 day before the bacterial formulation is administered to the subject.

68. The method of claim 57, wherein the immune checkpoint inhibitor is a protein or polypeptide that binds to an immune checkpoint protein.

69. The method of claim 68, wherein the immune checkpoint protein is CTLA4, PD-1, PD-L1, PD-L2, A2AR, B7-H3, B7-H4, BTLA, KIR, LAG3, TIM-3 or VISTA.

70. The method of claim 69, wherein the immune checkpoint protein is PD-1 or PD-L1.

71. The method of claim 57, wherein the immune checkpoint inhibitor is an antibody or antigen binding fragment thereof that binds to an immune checkpoint protein.

72. The method of claim 71, wherein the immune checkpoint protein is CTLA4, PD-1, PD-L1, PD-L2, A2AR, B7-H3, B7-H4, BTLA, KIR, LAG3, TIM-3 or VISTA.

73. The method of claim 72, wherein the immune checkpoint protein is PD-1 or PD-L1.

74. The method of claim 57, wherein the immune checkpoint inhibitor is nivolumab, pembrolizumab, pidilizumab, AMP-224, AMP-514, STI-A1110, TSR-042, RG-7446, BMS-936559, BMS-936558, MK-3475, CT 01 1, MPDL3280A, MEDI-4736, MSB-0020718C, AUR-012 and STI-A1010.

75. The method of claim 57, wherein the immune checkpoint inhibitor is administered by intravenous injection, intramuscular injection, intratumoral injection or subcutaneous injection.

76. A method of treating cancer in a human subject comprising administering to the subject a bacterial formulation comprising at least 5xl06 CFU of bacteria of the genera Bifidobacterium, wherein at least 50% of the bacteria in the bacterial formulation are of the genera Bifidobacterium.

77. The method of claim 76, wherein at least 90% of the bacteria in the bacterial formulation are of the genera Bifidobacterium.

78. The method of claim 76, wherein the bacteria of the genus Bifidobacterium comprise bacteria of the species Bifidobacterium lactis, Bifidobacterium bifidium, Bifidobacterium longum, Bifidobacterium animalis, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium catenulatum, Bifidobacterium pseudocatenulatum, Bifidobacterium adolescentis, Bifidobacterium angulatum, Bifidobacterium asteroides, Bifidobacterium boum, Bifidobacterium choerinum, Bifidobacterium coryneforme, Bifidobacterium cuniculi, Bifidobacterium denticolens, Bifidobacterium dentium, Bifidobacterium gallicum, Bifidobacterium gallinarum, Bifidobacterium indicum, Bifidobacterium inopinatum, Bifidobacterium magnum, Bifidobacterium merycicum, Bifidobacterium minimum, Bifidobacterium pseudolongum, Bifidobacterium pullorum, Bifidobacterium psychraerophilum, Bifidobacterium ruminantium, Bifidobacterium saeculare, Bifidobacterium scardovii, Bifidobacterium simiae, Bifidobacterium subtile, Bifidobacterium therammcidophilum, Bifidobacterium thermophilum, Bifidobacterium tsurumiense, Bifidobacterium urinalis or Bifidobacterium sp..

79. The method of claim 76, wherein the bacterial formulation is administered by oral administration or rectal administration.

80. The method of claim 79, wherein the bacterial formulation is administered by oral administration.

81. The method of claim 76, wherein the bacterial formulation is administered to the subject in two or more doses.

82. The method of claim 76, further comprising administering to the subject an antibiotic before the bacterial formulation is administered to the subject.

83. The method of claim 76, further comprising administering to the subject an immune checkpoint inhibitor.

84. The method of claim 83, wherein the immune checkpoint inhibitor is an antibody or antigen binding fragment thereof that binds to CTLA4, PD-1, PD-Ll, PD-L2, A2AR, B7-H3, B7-H4, BTLA, KIR, LAG3, TIM-3 or VISTA.

85. The method of claim 83, wherein the immune checkpoint inhibitor is an antibody or antigen binding fragment thereof that binds to PD-1 or PD-Ll .

86. The method of claim 83, wherein the immune checkpoint inhibitor is nivolumab, pembrolizumab, pidilizumab, AMP-224, AMP-514, STI-A1110, TSR-042, RG-7446, BMS-936559, BMS-936558, MK-3475, CT 01 1, MPDL3280A, MEDI-4736, MSB-0020718C, AUR-012 and STI-A1010.

87. A method of treating or preventing cancer in a recipient subject, the method comprising administering to the recipient subject a bacterial formulation comprising microflora obtained from a donor subject, wherein the donor subject comprises microflora that promotes the treatment of cancer by immune checkpoint inhibitor immunotherapy.

88. The method of claim 87, further comprising administering to the recipient subject an immune checkpoint inhibitor.

89. The method of claim 88, wherein the immune checkpoint inhibitor is a protein or polypeptide that specifically binds to an immune checkpoint protein.

90. The method of claim 88, wherein the immune checkpoint protein is selected from the group consisting of CTLA4, PD-1, PD-Ll, PD-L2, A2AR, B7-H3, B7-H4, BTLA, KIR, LAG3, TIM-3 or VISTA.

91. The method of claim 89 or 90, wherein the polypeptide or protein is an antibody or antigen-binding fragment thereof.

92. The method of claim 88, wherein the immune checkpoint inhibitor is an interfering nucleic acid molecule.

93. The method of claim 92, wherein the interfering nucleic acid molecule is an siRNA molecule, an shRNA molecule or an antisense RNA molecule.

94. The method of claim 88, wherein the immune checkpoint inhibitor is selected from the group consisting of nivolumab, pembrolizumab, pidilizumab, AMP-224, AMP-514, STI-A1110, TSR-042, RG-7446, BMS-936559, BMS-936558, MK-3475, CT 01 1, MPDL3280A, MEDI-4736, MSB-0020718C, AUR-012 and STI-A1010.

95. The method of any one of claims 88 to 94, wherein the immune checkpoint inhibitor is administered before the bacterial formulation.

96. The method of claim 95, wherein the immune checkpoint inhibitor is administered at least one day before the bacterial formulation.

97. The method of any one of claims 88 to 94, wherein the immune checkpoint is administered at about the same time as the bacterial formulation.

98. The method of claim 97, wherein the immune checkpoint inhibitor is administered on the same day as the bacterial formulation.

99. The method of any one of claims 88 to 94, wherein the immune checkpoint inhibitor is administered after the bacterial formulation.

100. The method of any one of claims 88 to 94, wherein the immune checkpoint inhibitor is administered at least one day after the bacterial formulation.

101. The method of any one of claims 88 to 100, wherein the immune checkpoint inhibitor is administered by injection.

102. The method of claim 101, wherein the injection is an intravenous, intramuscular, intratumoral or subcutaneous injection.

103. The method of any one of claims 87 to 102, wherein the microflora obtained from the donor subject is fecal material.

104. The method of any one of claims 87 to 102, wherein one or more parasitic or detrimental microbes are removed from the microflora before administration to the recipient subject.

105. The method of any one of claims 87 to 102, wherein the bacterial formulation is administered to the recipient subject by oral administration or by rectal administration.

106. The method of any one of claims 87 to 105, wherein the bacterial formulation is administered to the subject in two or more doses.

107. The method of claim 106, wherein the administration of the two or more doses are separated by at least 1 week.

108. The method of any one of claims 87 to 107, further comprising administering to the subject an antibiotic prior to the administration of the bacterial formulation.

109. The method of claim 108, wherein the antibiotic is administered to the subject at least 1 day before the bacterial formulation is administered to the subject.

110. The method of any one of claims 87 to 109, further comprising the step of obtaining the microflora from the donor subject.

111. A bacterial formulation comprising microflora obtained from a donor subject, wherein the donor subject comprises microflora that promotes the treatment of cancer by immune checkpoint inhibitor immunotherapy.

112. The bacterial formulation of claim 111 comprising fecal material of the donor subject.

113. The bacterial formulation of claim 111 or 112, wherein one or more detrimental microbes originally present in the microflora have been removed or killed.

114. The bacterial formulation of any one of claims 111 to 113, wherein the microflora is enriched for one or more microbes.

115. The bacterial formulation of claim 114, wherein the microflora is enriched for bacteria of the genera Bifidobacterium, Rikenella, Alistipes, Marinilabilia, or Anaerostipes .

116. The bacterial formulation of claim 115, wherein the bacterial formulation comprises at least 5xl06 CFU of bacteria of the genera Bifidobacterium, Rikenella, Alistipes, Marinilabilia, or Anaerostipes .

117. The bacterial formulation of claim 114, wherein the microflora is enriched for bacteria of the genera Bifidobacterium.

118. The bacterial formulation of claim 117, wherein the bacterial formulation comprises at least 5x106 CFU of bacteria of the genera Bifidobacterium.

119. The bacterial formulation of any one of claims 111 to 118, wherein the bacterial formulation comprises at least 5x106 CFU of bacteria.

120. The bacterial formulation of any one of claims 111 to 119, wherein the bacterial formulation further comprises a pharmaceutically acceptable carrier.

121. The bacterial formulation of claim 120, wherein the bacterial formulation is a solid formulation.

122. The bacterial formulation of claim 121, wherein the bacterial formulation is formulated as a powder, tablet, pill, capsule, cachet, suppository, or dispersible granule.

123. The bacterial formulation of claim 120, wherein the bacterial formulation is a liquid formulation.

124. The bacterial formulation of claim 123, wherein the bacterial formulation is formulated as an emulsion, syrup, elixir, aqueous solution or aqueous suspension.

125. The bacterial formulation of any one of claims 111 to 124 formulated for oral delivery.

126. The bacterial formulation of any one of claims 111 to 124 formulated for rectal delivery.

127. A method of treating or preventing cancer in a recipient subject, the method comprising administering to the recipient subject a bacterial formulation of any one of claims 111 to 126.

128. The method of claim 127, further comprising administering to the recipient subject an immune checkpoint inhibitor.

129. The method of claim 128, wherein the immune checkpoint inhibitor is a protein or polypeptide that specifically binds to an immune checkpoint protein.

130. The method of claim 128, wherein the immune checkpoint protein is selected from the group consisting of CTLA4, PD-1, PD-Ll, PD-L2, A2AR, B7-H3, B7-H4, BTLA, KIR, LAG3, TIM-3 or VISTA.

131. The method of claim 129 or 130, wherein the polypeptide or protein is an antibody or antigen-binding fragment thereof.

132. The method of claim 128, wherein the immune checkpoint inhibitor is an interfering nucleic acid molecule.

133. The method of claim 132, wherein the interfering nucleic acid molecule is an siRNA molecule, an shRNA molecule or an antisense RNA molecule.

134. The method of claim 128, wherein the immune checkpoint inhibitor is selected from the group consisting of nivolumab, pembrolizumab, pidilizumab, AMP-224, AMP-514, STI-A1110, TSR-042, RG-7446, BMS-936559, BMS-936558, MK-3475, CT 01 1, MPDL3280A, MEDI-4736, MSB-0020718C, AUR-012 and STI-A1010.

135. The method of any one of claims 128 to 134, wherein the immune checkpoint inhibitor is administered before the bacterial formulation.

136. The method of claim 135, wherein the immune checkpoint inhibitor is administered at least one day before the bacterial formulation.

137. The method of any one of claims 128 to 134, wherein the immune checkpoint is administered at about the same time as the bacterial formulation.

138. The method of claim 137, wherein the immune checkpoint inhibitor is administered on the same day as the bacterial formulation.

139. The method of any one of claims 128 to 134, wherein the immune checkpoint inhibitor is administered after the bacterial formulation.

140. The method of any one of claims 128 to 134, wherein the immune checkpoint inhibitor is administered at least one day after the bacterial formulation.

141. The method of any one of claims 128 to 140, wherein the immune checkpoint inhibitor is administered by injection.

142. The method of claim 141, wherein the injection is an intravenous, intramuscular, intratumoral or subcutaneous injection.

143. The method of any one of claims 127 to 142, wherein the bacterial formulation is administered to the recipient subject by oral administration or by rectal administration.

144. The method of any one of claims 127 to 143, wherein the bacterial formulation is administered to the subject in two or more doses.

145. The method of claim 144, wherein the administration of the two or more doses are separated by at least 1 week.

146. The method of any one of claims 127 to 145, further comprising administering to the subject an antibiotic prior to the administration of the bacterial formulation.

147. The method of claim 146, wherein the antibiotic is administered to the subject at least 1 day before the bacterial formulation is administered to the subject.

148. The method of any one of claims 127 to 147, further comprising the step of obtaining the microflora from the donor subject.

149. The method of any one of claims 127 to 148, where the donor subject is selected based on response to checkpoint inhibitor immunotherapy and/or the donor subject cancer type.

150. The bacterial formulation of any one of claims 1 11 to 126 wherein the donor is selected based on the donor's response to checkpoint inhibitor immunotherapy and/or the donor subject cancer type.