Microbial consortia for treating or preventing immune-related adverse events

Abstract

The present disclosure provides microbial consortia, and methods of making and using the same, comprising a complete microbiome replacement capable of stable engraftment in the gastrointestinal tract for the treatment or prevention of immune-related adverse events in subjects that have received or will receive an immunotherapy including an immune checkpoint inhibitor (ICI).

Description

PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT MICROBIAL CONSORTIA FOR TREATING OR PREVENTINGIMMUNE-RELATED ADVERSE EVENTSCROSS-REFERENCE TO RELATED APPLICATIONThis application claims priority to U.S. Provisional Application No. 63 / 682,156, filed5 August 12, 2024, the content of which is hereby incorporated by reference in its entirety, and to which priority is claimed.SEQUENCE LISTINGThe present specification makes reference to a Sequence Listing (submitted electronically as an .xml file named “0915920123. xml”). The 0915920123.xml file was generated on August10 12, 2025, and is 393,227 bytes in size. The entire contents of the Sequence Listing are hereby incorporated by reference.FIELD OF THE INVENTIONThe present disclosure relates to microbial consortia for the prevention or treatment of immune-associated adverse events, such as ICI induced colitis, in subjects that have received or will receive an immunotherapy including an immune checkpoint inhibitor (ICI).BACKGROUNDImmune checkpoint inhibitor (ICI) treatment has revolutionized cancer therapy by significantly enhancing the immune system's ability to target and destroy cancer cells. ICIs, which block proteins like PD-1, PD-L1, and CTLA-4, help restore the immune system's capability to20 recognize and attack tumors. This treatment has shown substantial efficacy in certain cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma, leading to improved survival rates and, in some cases, long-term remission. However, patients experiencing a positive response to ICI therapy may experience immune-related adverse events (AEs) that force termination of therapy of this life saving therapy. The incidence of ICI related AEs is increasing, especially with the growing demand and use of combination therapies. AEs from this treatment include colitis, hepatitis, dermatitis, and others. One of the most common AEs is colitis, which is the primary AE that causes patients to have to go off their ICI therapy, as once grade 1 colitis has been observed, the AE will not resolve on its own. Left untreated, conditions will worsen, which have resulted in mortalities. The standard of care, therefore, is the use of steroids (e.g., prednisone)30 followed by 2nd line inflammation treatment (e.g., anti-TNF) if symptoms do not resolve. However, a regimen of switching patients between immunostimulatory and immunosuppressive therapies is generally regarded as non-optimal and it may reduce quality of life, increase the riskACTIVE 511662979.2 1PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT of morbidity and mortality. A promising approach to avoid immunosuppressive therapy or to reduce its dosage is to utilize the benefits of fecal microbiota transfer (FMT), where transfer of a diverse microbiome has been shown to resolve a host of gastrointestinal conditions. However, FMT comes with its own drawbacks which stem from the risk of including unintended pathogens5 and the inability to scale up a consistent product that can meet clinical trial or commercial demand.Therefore, the need exists to develop safe and effective alternative treatments to FMT therapies to address immune-related adverse events such as ICI induced colitis.SUMMARY OF THE INVENTIONThe present disclosure relates to a method of ameliorating one or more phenotypes10 associated with an immune-related adverse event in a subject undergoing immunotherapy.In certain non-limiting embodiments, the present disclosure relates to a plurality of microbes comprising the microbes set forth in Figures 5A-5C. In certain non-limiting embodiments, the present disclosure relates to a plurality of microbes consisting of the microbes set forth in Figures 5A-5C. In certain non-limiting embodiments, the present disclosure relates to a plurality of microbes comprising strains of the microbes set forth in Figure 11. In certain nonlimiting embodiments, the present disclosure relates to a plurality of microbes consisting of strains of the microbes set forth in Figure 11.In certain non-limiting embodiments, the present disclosure relates to a pharmaceutical composition comprising the plurality of microbes disclosed herein. In certain embodiments, the20 pharmaceutical composition comprises between about 1 x 107and about 1 x 1013viable cells, between about 1 x 108and about 1 x io13viable cells, between about 1 x io9and about 1 x io13viable cells, between about 1 x io10and about 1 x io13viable cells, between about 1 x io11and about 1 x 1013viable cells, between about 1 x io12and about 1 x io13viable cells, between about 1 x io7and about 1 x io12viable cells, between about 1 x io7and about 1 x io11viable cells, between about 1 x io7and about 1 x io10viable cells, between about 1 x io7and about 1 x io9viable cells, between about 1 x io7and about 1 x io8viable cells, between about 1 x io8and about 1 x io9viable cells, between about 1 x io9and about 1 x io10viable cells, between about 1 x io11and about 1 x io12viable cells, between about 1 x io12and about 1 x io13viable cells, between about 5 x io9and about 5 x io10viable cells, between about 5 x io10and about 5 x io1130 viable cells, or between about 5 x io11and about 5 x io12viable cells. In certain embodiments, the pharmaceutical composition comprises up to about 1011viable cells or up to about 1012viable cells.In certain non-limiting embodiments, the present disclosure relates to a method of ameliorating one or more phenotypes associated with an immune-related adverse event in aACTIVE 511662979.2 2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT subject undergoing immunotherapy, the method comprising administering an effective amount of the plurality of microbes disclosed herein.In certain non-limiting embodiments, the present disclosure relates to a method of ameliorating one or more phenotypes associated with an immune-related diarrhea and / or colitis in5 a subject undergoing immunotherapy, the method comprising administering an effective amount of the plurality of microbes disclosed herein.In certain non-limiting embodiments, the present disclosure relates to a method of ameliorating one or more phenotypes associated with an immune-related diarrhea and / or colitis in a subject in need thereof, the method comprising administering an effective amount of the plurality10 of microbes disclosed herein. In certain embodiments, the method comprises administering a loading dose and one or more maintenance doses of the plurality of microbes or a pharmaceutical composition thereof. In certain embodiments, the loading dose comprises about 1012viable cells. In certain embodiments, the loading dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise about 1011viable cells. In certain embodiments, the loading dose comprises 10 coated enteric capsules. In certain embodiments, the loading dose is administered for 1 day. In certain embodiments, the loading dose is administered twice a day. In certain embodiments, the maintenance dose comprises about2 x io11viable cells. In certain embodiments, each maintenance dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise20 about 1011viable cells. In certain embodiments, each maintenance dose comprises 2 coated enteric capsules. In certain embodiments, the maintenance doses are administered for 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks,3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 10 weeks, or 12 weeks following the last loading dose. In certain embodiments, the plurality of microbes or the pharmaceutical composition thereof25 is present in a food product, a probiotic, a prebiotic, or a combination thereof. In certain embodiments, the plurality of microbes or the pharmaceutical composition thereof is administered orally or rectally. In certain embodiments, the plurality of microbes or the pharmaceutical composition thereof is administered via colonoscope.In certain non-limiting embodiments, the present disclosure relates to a method of ameliorating one or more phenotypes associated with an immune-related adverse event in a subject undergoing immunotherapy. In certain embodiments, the method comprises administering an effective amount of a microbial consortium or a pharmaceutical composition thereof comprising: (a) Clostridium citroniae, Bacteroides salyersiae, Blautia obeum, Parabacteroides merdae, Parabacteroides distasonis, Anaerostipes hadrus, Lachnospiraceae sp.35 FBI00033 (also known as Lacrimispora amygdalind), Eubacterium eligens, BifidobacteriumACTIVE 511662979.2 3PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT dentium, Blautia wexlerae, Fusicatenibacter saccharivorans, Bacteroides nordii, Dorea formicigenerans, Dorea longicatena, Bacteroides stercorirosoris (also known as Bacteroides oleiciplenus), Bifidobacterium longum, Bacteroides kribbi (also known as Bacteroides koreensis), Lachnospiraceae sp. FBI00071 (also known as Roseburia faecis), Bacteroides thetaiotaomicron,5 Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also known as Clostridium symbiosum), Coprococcus comes, Blautia faecis, Hungatella hathewayi, Bacteroides stercoris, Collinsella aerofaciens, Hungatella effluvii, Bifidobacterium adolescentis, Bifidobacterium catenulatum, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Bacteroides faecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as10 Clostridium prolinivorans), Ruminococcus faecis, Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, Butyricimonas faecihominis, Eisenbergiella tayi, Acidaminococcus intestini, Emergencia timonensis, Bifidobacterium pseudocatenulatum, Eubacterium hallii (also known as Anaerobutyricum halin'), Anaerofustis stercorihominis, Eubacterium ventriosum, Blautia hydrogenotrophica, Lachnospiraceae sp. FBI00290 (also known as Eubacterium ruminantium), Acutalibacter timonensis (also known as Neglecta timonensis), Alistipes onderdonkii, Bacteroides uniformis, Eubacterium rectale (also known as Agathobacter rectalis), Alistipes timonensis, Bacteroides kribbi, Coprococcus eutactus, Bilophila wadsworthia, Bacteroides caccae, Alistipes shahii, Parasutterella excrementihominis, Paraprevotella clara, Sutterella wadsworthensis, Sutterella massiliensis, Porphyromonas asaccharolytica, Ruminococcus bromii, Monoglobus pectinilyticus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter pamelaeae, Bacteroides uniformis, Gordonibacter pamelaeae, Bacteroides fragilis, Phascolarctobacterium faecium, Monoglobus pectinilyticus, Clostridium aldenense,25 Ruthenibacterium lactatiformans, Bacteroides ovatus (also known as Bacteroides koreensis), Bifidobacterium bifidum, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutterella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis), Alistipes senegalensis, Ruminococcaceae sp. FBI00233 (also known as Anaerotruncus colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum, Faecalibacterium prausnitzii, Turicibacter sanguinis, Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, Methanobrevibacter smithii, Bifidobacterium adolescentis (also known as Bifidobacterium faecale), Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes, Fusicatenibacter35 saccharivorans, Eggerthella lenta, Eubacterium eligens, Bacteroides xylanisolvens, LactobacillusACTIVE 511662979.2 4PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT rogosae (also known as Lachnospira pectinoschiza), Clostridium citroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenta, Blautia wexlerae (also known as Blautia luti), Lachnoclostridium pacaense, Bacteroides vulgatus, Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis, Anaerostipes hadrus, Bifidobacterium5 adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolteae, Eisenbergiella tayi, Dorea longicatena, Eggerthella lenta, Bacteroides stercoris, Hungatella hathewayi, Bacteroides xylanisolvens, Alistipes putredinis, Dialister succinatiphilus, Akkermansia muciniphila, Ruminococcus bromii, Dialister invisus, Bacteroides massiliensis, Bilophila wadsworthia, Holdemanella biformis, Parasutterella excrementihominis, Alistipes sp. FBI00180 (also known10 as Alistipes senegalensis), Bacteroides coprocola, Alistipes sp. FBI00238 (also known as Alistipes finegoldii), Alistipes putredinis, Eubacterium xylanophilum, and Senegalimassilia anaerobia, or a functional equivalent thereof; (b) Clostridium citroniae, Bacteroides salyersiae, Blautia obeum, Parabacteroides merdae, Parabacteroides distasonis, Anaerostipes hadrus, Lachnospiraceae sp. FBI00033 (also known as Lacrimispora amygdalina , Eubacterium eligens, Bifidobacterium dentium, Blautia wexlerae, Fusicatenibacter saccharivorans, Bacteroides nordii, Dorea formicigenerans, Dorea longicatena, Bacteroides stercorirosoris (also known as Bacteroides oleiciplenus), Bifidobacterium longum, Bacteroides kribbi (also known as Bacteroides koreensis), Lachnospiraceae sp. FBI00071 (also known as Roseburia faecis), Bacteroides thetaiotaomicron, Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also20 known as Clostridium symbiosum), Coprococcus comes, Blautia faecis, Hungatella hathewayi, Bacteroides stercoris, Collinsella aerofaciens, Hungatella effluvia (also known as Hungatella effluvii), Bifidobacterium adolescentis, Bifidobacterium catenulatum, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Bacteroides faecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as Clostridium prolinivorans), Ruminococcus faecis,25 Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, Butyricimonas faecihominis, Eisenbergiella tayi, Acidaminococcus intestini, Emergencia timonensis, Bifidobacterium pseudocatenulatum, Eubacterium hallii (also known as Anaerobutyricum hallii), Anaerofustis stercorihominis, Eubacterium ventriosum, Blautia hydrogenotrophica, and Lachnospiraceae sp. FBI00290 (also known as Eubacterium ruminantium), or a functional equivalent thereof; (c) Acutalibacter timonensis (also known as Neglecta timonensis), Alistipes onderdonkii, Bacteroides uniformis, Eubacterium rectale (also known as Agathobacter rectalis), Alistipes timonensis, Bacteroides kribbi, Coprococcus eutactus, Bilophila wadsworthia, Bacteroides caccae, Alistipes shahii,35 Parasutterella excrementihominis, Paraprevotella clara, Sutterella wadsworthensis, SutterellaACTIVE 511662979.2 5PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT massiliensis, Porphyromonas asaccharolylica. Ruminococcus bromii, Monoglobus pectinilyticus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter pamelaeae, Bacteroides uniformis, Gordonibacter pamelaeae, Bacteroides fragilis, Phascolarctobacterium faecium. Monoglobus pectinilyticus, Clostridium aldenense.5 Ruthenibacterium lactatif ormans, Bacteroides ovatus (also known as Bacteroides koreensis). Bifidobacterium bifidum, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutter ella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis), Alistipes senegalensis, Ruminococcaceae sp. FBI00233 (also known as Anaerotruncus colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum,10 Faecalibacterium prausnitzii, Turicibacter sanguinis, Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, and Methanobrevibacter smithii, or a functional equivalent thereof; (d) Bifidobacterium adolescentis (also known as Bifidobacterium faecale), Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes, Fusicatenibacter saccharivorans, Eggerthella lenta, Eubacterium eligens, Bacteroides xylanisolvens, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Clostridium citroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenta, Blautia wexlerae (also known as Blautia luti), Lachnoclostridium pacaense, Bacteroides vulgatus, Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis, Anaerostipes hadrus, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolteae, Eisenbergiella tayi, Dorea longicatena, Eggerthella lenta, Bacteroides stercoris, Hungatella hathewayi, and Bacteroides xylanisolvens or a functional equivalent thereof; (e) Alistipes putredinis, Dialister succinatiphilus, Akkermansia muciniphila, Ruminococcus bromii, Dialister invisus, Bacteroides massiliensis, Bilophila wadsworthia, Holdemanella25 biformis, Parasutterella excrementihominis, Alistipes sp. FBI00180 (also known as Alistipes senegalensis), Bacteroides coprocola, Alistipes sp. FBI00238 (also known as Alistipes finegoldii), Alistipes putredinis, Eubacterium xylanophilum, and Senegalimassilia anaerobia or a functional equivalent thereof; (f) Bifidobacterium adolescentis, Bifidobacterium bifidum, Bifidobacterium catenulatum, Bifidobacterium dentium, Bifidobacterium faecale, Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Collinsella aerofaciens, Eggerthella lenta, Gordonibacter pamelaeae, Senegalimassilia anaerobia, Alistipes finegoldii, Alistipes onderdonkii, Alistipes putredinis, Alistipes senegalensis, Alistipes shahii, Alistipes timonensis, Bacteroides caccae, Bacteroides coprocola, Bacteroides faecis, Bacteroides finegoldii, Bacteroides fragilis, Bacteroides koreensis, Bacteroides kribbi, Bacteroides massiliensis, Bacteroides nordii,35 Bacteroides oleiciplenus, Bacteroides salyersiae, Bacteroides stercoris, BacteroidesACTIVE 511662979.2 6PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENT thetaiotaomicron, Bacteroides uniformis, Bacteroides xylanisolvens, Barnesiella intestinihominis,Butyricimonas faecihominis, Parabacteroides distasonis, Parabacteroides merdae, Paraprevotella clara. Phocaeicola vulgatus, Porphyromonas asaccharolytica, Methanobrevibacter smilhii. Acidaminococcus inleslini. Agathobacter reclalis. Anaerobutyricum5 hallii. Anaerofustis stercorihominis, Anaerostipes hadrus, Anaerotruncus colihominis, Blautia faecis, Blautia hydrogenotrophica, Blautia luti, Blautia obeum, Blautia wexlerae, Christensenella hongkongensis, Clostridium aldenense, Clostridium bolteae, Clostridium citroniae, Clostridium clostridioforme, Clostridium prolinivorans, Clostridium scindens, Clostridium symbiosum, Coprococcus comes, Coprococcus eutactus, Dialister invisus, Dialister succinatiphilus, Dielma10 fastidiosa, Dorea formicigenerans, Dorea longicatena, Eisenbergiella tayi, Emergencia timonensis, Eubacterium eligens, Eubacterium ruminantium, Eubacterium siraeum, Eubacterium ventriosum, Eubacterium xylanophilum, Faecalibacterium prausnilzii, Fusicatenibacter saccharivorans, Holdemanella biformis, Hungatella effluvii, Hungatella hathewayi, Lachnoclostridium pacaense, Lachnospira peclinoschiza, Lacrimispora amygdalina, Longicatena caecimuris, Megasphaera massiliensis, Merdimmobilis hominis. Monoglobus pectinilyticus, Neglecta timonensis, Phascolarctobacterium faecium, Roseburia faecis, Roseburia hominis, Ruminococcus bromii, Ruminococcus faecis, Ruthenibacterium lactatif ormans, Turicibacter sanguinis, Parasutterella excrementihominis, Sutterella massiliensis, Sutterella wadsworthensis, Bilophila wadsworthia, Akkermansia muciniphila, or a functional equivalent20 thereof; (g) FBI00001, FBI00002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033, FBI00034, FBI00043, FBI00044, FBI00048, FBI00050, FBI00051, FBI00057, FBI00059,FBI00060, FBI00070, FBI00071, FBI00076, FBI00079, FBI00087, FBI00093, FBI00102,FBI00109, FBI00117, FBI00120, FBI00125, FBI00127, FBI00128, FBI00145, FBI00162,FBI00174, FBI00184, FBI00190, FBI00191, FBI00194, FBI00198, FBI00199, FBI00200,25 FBI00201, FBI00205, FBI00206, FBI00211, FBI00220, FBI00221, FBI00236, FBI00245,FBI00248, FBI00251, FBI00254, FBI00267, FBI00278, FBI00288, FBI00290, FBI00004,FBI00012, FBI00015, FBI00018, FBI00019, FBI00021, FBI00038, FBI00040, FBI00046,FBI00061, FBI00066, FBI00075, FBI00077, FBI00080, FBI00081, FBI00085, FBI00092,FBI00097, FBI00099, FBI00112, FBI00132, FBI00137, FBI00140, FBI00149, FBI00151,FBI00176, FBI00189, FBI00197, FBI00208, FBI00212, FBI00224, FBI00226, FBI00229,FBI00233, FBI00235, FBI00237, FBI00243, FBI00244, FBI00258, FBI00260, FBI00263,FBI00270, FBI00273, FBI00277, FBI00292, FBI00009, FBI00011, FBI00016, FBI00020,FBI00025, FBI00027, FBI00030, FBI00047, FBI00052, FBI00053, FBI00056, FBI00062,FBI00078, FBI00096, FBI00104, FBI00110, FBI00111, FBI00113, FBI00115, FBI00116,35 FBI00123, FBI00124, FBI00126, FBI00135, FBI00147, FBI00159, FBI00167, FBI00170,ACTIVE 511662979.2 7PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT FBI00232, FBI00255, FBI00271, FBI00022, FBI00049, FBI00068, FBI00069, FBI00152,FBI00165, FBI00171, FBI00175, FBI00177, FBI00180, FBI00182, FBI00238, FBI00269,FBI00274, and FBI00281, or a functional equivalent thereof; (h) FBI00001, FB 100002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033, FBI00034, FBI00043, FBI00044,5 FBI00048, FBI00050, FBI00051, FBI00057, FBI00059, FBI00060, FBI00070, FBI00071,FBI00076, FBI00079, FBI00087, FBI00093, FBI00102, FBI00109, FBI00117, FBI00120,FBI00125, FBI00127, FBI00128, FBI00145, FBI00162, FBI00174, FBI00184, FBI00190,FBI00191, FBI00194, FBI00198, FBI00199, FBI00200, FBI00201, FBI00205, FBI00206,FBI00211, FBI00220, FBI00221, FBI00236, FBI00245, FBI00248, FBI00251, FBI00254,10 FBI00267, FBI00278, FB 100288, and FBI00290 or a functional equivalent thereof; (i) FBI00004,FBI00012, FBI00015, FBI00018, FBI00019, FBI00021, FBI00038, FBI00040, FBI00046,FBI00061, FBI00066, FBI00075, FBI00077, FBI00080, FBI00081, FBI00085, FBI00092,FBI00097, FBI00099, FBI00112, FBI00132, FBI00137, FBI00140, FBI00149, FBI00151,FBI00176, FBI00189, FBI00197, FBI00208, FBI00212, FBI00224, FBI00226, FBI00229,FBI00233, FBI00235, FBI00237, FBI00243, FBI00244, FBI00258, FBI00260, FBI00263,FBI00270, FB 100273, FB 100277, and FBI00292, or a functional equivalent thereof; (j) FBI00009, FBI00011, FBI00016, FBI00020, FBI00025, FBI00027, FBI00030, FBI00047, FBI00052,FBI00053, FBI00056, FBI00062, FBI00078, FBI00096, FBI00104, FBI00110, FBI00111,FBI00113, FBI00115, FBI00116, FBI00123, FBI00124, FBI00126, FBI00135, FBI00147,FBI00159, FBI00167, FBI00170, FBI00232, FBI00255, and FBI00271, or a functional equivalent thereof; or (k) FBI00022, FBI00049, FBI00068, FBI00069, FBI00152, FBI00165, FBI00171, FBI00175, FBI00177, FBI00180, FBI00182, FBI00238, FBI00269, FBI00274, and FBI00281, or a functional equivalent thereof.In certain embodiments, the microbial consortium comprises the plurality of microbes set25 forth in Figures 5 A-5C. In certain embodiments, the microbial consortium consists of the plurality of microbes set forth in Figures 5A-5C. In certain embodiments, the microbial consortium comprises the plurality of microbes comprising strains of the microbes set forth in Figure 11. In certain embodiments, the microbial consortium consists of the plurality of microbes consisting of strains of the microbes set forth in Figure 11.In certain embodiments, the immune-related adverse event is a gastrointestinal toxicity, a dermatologic toxicity, a hepatotoxicity, an endocrinopathy, pneumonitis, arthralgia, arthritis, nephritis, a cardiotoxicity, neurological toxicity, or a hematologic toxicity, or combinations thereof. In certain embodiments, the phenotype associated with the immune-related adverse event is impaired intestinal barrier integrity. In certain embodiments, the phenotype associated with the35 immune-related adverse event is due to altered absolute abundance levels of short chain fatty acidsACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT (SCFAs) or altered relative abundance levels of SCFAs. In certain embodiments, the phenotype associated with the immune-related adverse event is due to altered absolute abundance levels of conjugated bile acids, primary bile acids, secondary bile acids or altered relative abundance levels of the bile acid pool. In certain embodiments, the immune-related adverse event is colitis. In5 certain embodiments, the phenotype associated with colitis is abdominal pain, bloated stomach, diarrhea, blood in the stool, loss of appetite, weight loss, vomiting, or fever. In certain embodiments, (a) the phenotype associated with the dermatologic toxicity is a rash, pruritus, or vitiligo; (b) the phenotype associated with the hepatotoxicity is hepatitis; (c) the phenotype associated with the endocrinopathy is an inflammation of an endocrine gland; (d) the phenotype10 associated with the pneumonitis is cough, shortness of breath or chest pain; (e) the phenotype associated with the arthralgia or arthritis is joint pain or inflammation mimicking autoimmune arthritis; (f) the phenotype associated with the cardiotoxicity is inflammation of the heart muscle, inflammation of the lining around the heart, myocarditis, or pericarditis; (g) the phenotype associated with the neurological toxicity is peripheral neuropathy, nerve damage, myasthenia gravis, or neuromuscular disorder; and (h) the phenotype associated with the hematologic toxicity is immune thrombocytopenia or hemolytic anemia.In certain embodiments, the immunotherapy comprises an immune checkpoint inhibitor (ICI). In certain embodiments, the ICI comprises an anti-PDl antibody, an anti-PD-Ll antibody, an anti-CTLA-4 antibody, an anti-BTLA antibody, an anti-TIM3 antibody, an anti-LAG-3 antibody, or a combination thereof. In certain embodiments, the ICI comprises an anti-PDl antibody and an anti-CTLA-4 antibody. In certain embodiments, the anti-PDl antibody comprises pembrolizumab, nivolumab, cemiplimab, dostarlimab, retifanlimab-dlwr, tislelizumab, or combinations thereof. In certain embodiments, the anti-PD-Ll antibody comprises atezolizumab, avelumab, durvalumab, or a combination thereof. In certain embodiments, the anti-CTLA425 antibody comprises ipilimumab or tremelimumab, or a combination thereof.In certain embodiments, the microbial consortium or a pharmaceutical composition thereof comprises between about 1 x 107and about 1 x 1013viable cells, between about 1 x 108and about 1 x io13viable cells, between about 1 x io9and about 1 x io13viable cells, between about 1 x 1010and about 1 x io13viable cells, between about 1 x io11and about 1 x io13viable cells, between about 1 x io12and about 1 x io13viable cells, between about 1 x io7and about 1 x io12viable cells, between about 1 x io7and about 1 x io11viable cells, between about 1 x io7and about 1 x io10viable cells, between about 1 x io7and about 1 x io9viable cells, between about 1 x io7and about 1 x io8viable cells, between about 1 x io8and about 1 x io9viable cells, between about 1 x io9and about 1 x io10viable cells, between about 1 x io11and about 1 x io1235 viable cells, between about 1 x 1Q12and about 1 x 1Q13viable cells, between about 5 x 1Q9andACTIVE 511662979.2 9PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT about 5 x io10viable cells, between about 5 x io10and about 5 x io11viable cells, or between about 5 x io11and about 5 x io12viable cells. In certain embodiments, the microbial consortium or a pharmaceutical composition thereof comprises up to about 1011viable cells or up to about 1012viable cells.5 In certain embodiments, the method comprises administering a loading dose and one or more maintenance doses of the microbial consortium or a pharmaceutical composition thereof. In certain embodiments, the loading dose is administered for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days after the immunotherapy. In certain embodiments, the loading dose is administered 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours,10 9 hours, 10, hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 2 months, 3 months, 4 months, 5 months, 6 months or longer after the onset of one or more phenotypes associated with an immune-related adverse event. In certain embodiments, the loading dose is administered daily for the duration of the ICI therapy administered to the patient. In certain embodiments, the maintenance doses are administered for at least 21 days, at least 1 month, at least 2 months, at least 4 months, at least 6 months, at least 8 months, at least 10 months, at least 12 months, at least 18 months, or at least 24 months following the last loading dose. In certain embodiments, the loading dose comprises about 1012viable cells.In certain embodiments, the loading dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise about 1011viable cells. In certain embodiments, the loading dose comprises 10 coated enteric capsules. In certain embodiments, the loading dose is administered for 1 day. In certain embodiments, the loading dose is administered twice a day. In certain embodiments, the maintenance dose comprises about25 2 x io11viable cells. In certain embodiments, each maintenance dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise about 1011viable cells. In certain embodiments, each maintenance dose comprises 2 coated enteric capsules. In certain embodiments, the maintenance doses are administered for 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks,3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 10 weeks, or 12 weeks following the last loading dose. In certain embodiments, the microbial consortium or pharmaceutical composition thereof is present in a food product, a probiotic, a prebiotic, or a combination thereof. In certain embodiments, the microbial consortium or pharmaceutical composition is administered orally or rectally. In certain embodiments, the microbial consortium or pharmaceutical composition is35 administered via colonoscope.ACTIVE 511662979.2 10PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT In certain non-limiting embodiments, the present disclosure relates to a method for preventing one or more phenotypes associated with an immune-related adverse event. In certain embodiment, the method comprising administering an effective amount of a microbial consortium or a pharmaceutical composition thereof comprising: (a) Clostridium citroniae, Bacteroides5 salyersiae, Blautia obeum, Parabacteroides merdae, Parabacteroides distasonis, Anaerostipes hadrus, Lachnospiraceae sp. FBI00033 (also known as Lacrimispora amygdalina), Eubacterium eligens, Bifidobacterium dentium, Blautia wexlerae, Fusicatenibacter saccharivorans, Bacteroides nordii, Dorea formicigenerans, Dorea longicatena, Bacteroides stercorirosoris (also known as Bacteroides oleiciplenus), Bifidobacterium longum, Bacteroides kribbi (also known as10 Bacteroides koreensis), Lachnospiraceae sp. FBI00071 (also known as Roseburia fiaecis), Bacteroides thetaiotaomicron, Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also known as Clostridium symbiosum), Coprococcus comes, Blautia fiaecis, Hungatella hathewayi, Bacteroides stercoris, Collinsella aerofaciens, Hungatella efifluvii, Bifidobacterium adolescentis, Bifidobacterium catenulatum, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Bacteroides fiaecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as Clostridium prolinivorans), Ruminococcus fiaecis, Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, Butyricimonas faecihominis, Eisenbergiella tayi, Acidaminococcus intestini, Emergencia timonensis, Bifidobacterium pseudocatenulatum, Eubacterium hallii (also known as Anaerobutyricum halin'), Anaerofustis stercorihominis, Eubacterium ventriosum, Blautia hydrogenotrophica, Lachnospiraceae sp. FBI00290 (also known as Eubacterium ruminantium), Acutalibacter timonensis (also known as Neglecta timonensis), Alistipes onderdonkii, Bacteroides uniformis, Eubacterium rectale (also known as25 Agathobacter rectalis), Alistipes timonensis, Bacteroides kribbi, Coprococcus eutactus, Bilophila wadsworthia, Bacteroides caccae, Alistipes shahii, Parasutterella excrementihominis, Paraprevotella clara, Sutterella wadsworthensis, Sutterella massiliensis, Porphyromonas asaccharolytica, Ruminococcus bromii, Monoglobus pectinilyticus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter pamelaeae, Bacteroides uniformis, Gordonibacter pamelaeae, Bacteroides fragilis, Phascolarctobacterium faecium, Monoglobus pectinilyticus, Clostridium aldenense, Ruthenibacterium lactatiformans, Bacteroides ovatus (also known as Bacteroides koreensis), Bifidobacterium bifidum, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutterella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis),35 Alistipes senegalensis, Ruminococcaceae sp. FBI00233 (also known as AnaerotruncusACTIVE 511662979.2 11PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum, Faecalibacterium prausnitzii, Turicibacter sanguinis, Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, Methanobrevibacter smithii, Bifidobacterium adolescentis (also known as5 Bifidobacterium faecale), Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes, Fusicatenibacter saccharivorans, Eggerthella lenta, Eubacterium eligens, Bacteroides xylanisolvens, Lactobacillus rogosae (also known as Lachnospira peclinoschiza , Clostridium citroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenta, Blautia wexlerae (also known as Blautia luti), Lachnoclostridium10 pacaense, Bacteroides vulgatus, Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis, Anaerostipes hadrus, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolteae, Eisenbergiella tayi, Dorea longicatena, Eggerthella lenta, Bacteroides stercoris, Hungatella hathewayi, Bacteroides xylanisolvens, Alistipes putredinis, Dialister succinatiphilus, Akkermansia muciniphila, Ruminococcus bromii, Dialister invisus, Bacteroides massiliensis, Bilophila wadsworthia, Holdemanella biformis, Parasutterella excrementihominis, Alistipes sp. FBI00180 (also known as Alistipes senegalensis), Bacteroides coprocola, Alistipes sp. FBI00238 (also known as Alistipes finegoldii), Alistipes putredinis, Eubacterium xylanophilum, and Senegalimassilia anaerobia, or a functional equivalent thereof; (b) Clostridium citroniae, Bacteroides salyersiae, Blautia obeum, Parabacteroides merdae, Parabacteroides distasonis, Anaerostipes hadrus, Lachnospiraceae sp. FBI00033 (also known as Lacrimispora amygdalina , Eubacterium eligens, Bifidobacterium dentium, Blautia wexlerae, Fusicatenibacter saccharivorans, Bacteroides nordii, Dorea formicigenerans, Dorea longicatena, Bacteroides stercorirosoris (also known as Bacteroides oleiciplenus), Bifidobacterium longum, Bacteroides kribbi (also known as Bacteroides koreensis),25 Lachnospiraceae sp. FBI00071 (also known as Roseburia faecis), Bacteroides thetaiotaomicron, Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also known as Clostridium symbiosum), Coprococcus comes, Blautia faecis, Hungatella hathewayi, Bacteroides stercoris, Collinsella aerofaciens, Hungatella effluvia (also known as Hungatella effluvii), Bifidobacterium adolescentis, Bifidobacterium catenulatum, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Bacteroides faecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as Clostridium prolinivorans), Ruminococcus faecis, Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, Butyricimonas faecihominis, Eisenbergiella tayi,35 Acidaminococcus intestini, Emergencia timonensis, Bifidobacterium pseudocatenulatum,ACTIVE 511662979.2 12PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Eubacterium hallii (also known as Anaerobutyricum hallii), Anaerofustis stercorihominis, Eubacterium ventriosum, Blautia hydrogenotrophica, and Lachnospiraceae sp. FBI00290 (also known as Eubacterium ruminanlium , or a functional equivalent thereof; (c) Acutalibacter timonensis (also known as Neglecta limonensis), Alistipes onderdonkii, Bacteroides uniformis,5 Eubacterium rectale (also known as Agathobacter rectalis), Alistipes timonensis, Bacteroides kribbi, Coprococcus eutactus, Bilophila wadsworthia, Bacteroides caccae, Alistipes shahii, Parasutterella excrementihominis, Paraprevotella clara, Sutterella wadsworthensis, Sutterella massiliensis, Porphyromonas asaccharolytica, Ruminococcus bromii, Monoglobus pectinilyticus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter10 pamelaeae, Bacteroides uniformis, Gordonibacter pamelaeae, Bacteroides fragilis, Phascolarctobacterium faecium, Monoglobus pectinilyticus, Clostridium aldenense, Ruthenibacterium lactatif ormans, Bacteroides ovatus (also known as Bacteroides koreensis). Bifidobacterium bifidum, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutterella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis), Alistipes senegalensis, Ruminococcaceae sp. FBI00233 (also known as Anaerotruncus colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum, Faecalibacterium prausnitzii, Turicibacter sanguinis, Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, and Methanobrevibacter smithii or a functional equivalent20 thereof; (d) Bifidobacterium adolescentis (also known as Bifidobacterium faecale), Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes, Fusicatenibacter saccharivorans, Eggerthella lenta, Eubacterium eligens, Bacteroides xylanisolvens, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Clostridium citroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenta, Blautia25 wexlerae (also known as Blautia luti), Lachnoclostridium pacaense, Bacteroides vulgatus, Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis, Anaerostipes hadrus, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolteae, Eisenbergiella tayi, Dorea longicatena, Eggerthella lenta, Bacteroides stercoris, Hungatella hathewayi, and Bacteroides xylanisolvens or a functional equivalent thereof; (e) Alistipes putredinis, Dialister succinatiphilus, Akkermansia muciniphila, Ruminococcus bromii, Dialister invisus, Bacteroides massiliensis, Bilophila wadsworthia, Holdemanella biformis, Parasutterella excrementihominis, Alistipes sp. FBI00180 (also known as Alistipes senegalensis), Bacteroides coprocola, Alistipes sp. FBI00238 (also known as Alistipes finegoldii), Alistipes putredinis, Eubacterium xylanophilum, and Senegalimassilia anaerobia or a functional35 equivalent thereof; (f) Bifidobacterium adolescentis, Bifidobacterium bifidum, BifidobacteriumACTIVE 511662979.2 13PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENT catenulatum, Bifidobacterium dentium, Bifidobacterium faecale, Bifidobacterium longum,Bifidobacterium pseudocatenulatum, Collinsella aerofaciens, Eggerthella lenta, Gordonibacter pamelaeae, Senegalimassilia anaerobia. Alistipes finegoldii. Alistipes onderdonkii. Alistipes pulredinis. Alistipes senegalensis. Alistipes shahii. Alistipes timonensis, Bacteroides caccae,5 Bacteroides coprocola. Bacteroides faecis, Bacteroides finegoldii, Bacteroides fragilis, Bacteroides koreensis, Bacteroides kribbi, Bacteroides massiliensis, Bacteroides nordii, Bacteroides oleiciplenus, Bacteroides salyer siae, Bacteroides slercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides xylanisolvens, Barnesiella inleslinihominis, Butyricimonas faecihominis. Par abac ter oides dislasonis, Parabacteroides merdae.10 Paraprevotella clara, Phocaeicola vulgatus, Porphyromonas asaccharolytica, Methanobrevibacter smithii, Acidaminococcus intestini, Agathobacter rectalis, Anaerobutyricum hallii, Anaerofustis stercorihominis, Anaerostipes hadrus, Anaerotruncus colihominis, Blautia faecis, Blautia hydrogenotrophica, Blautia luti, Blautia obeum, Blautia wexlerae, Christensenella hongkongensis, Clostridium aldenense, Clostridium bolleae, Clostridium cilroniae, Clostridium closlridioforme, Clostridium prolinivorans, Clostridium scindens, Clostridium symbiosum, Coprococcus comes, Coprococcus eutactus, Dialister invisus, Dialister succinatiphilus, Dielma fastidiosa, Dorea formicigenerans, Dorea longicatena, Eisenbergiella tayi, Emergencia timonensis, Eubacterium eligens, Eubacterium ruminantium, Eubacterium siraeum, Eubacterium ventriosum, Eubacterium xylanophilum, Faecalibacterium prausnitzii, Fusicatenibacter20 saccharivorans, Holdemanella biformis, Hungatella effluvii, Hungatella hathewayi, Lachnoclostridium pacaense, Lachnospira pectinoschiza, Lacrimispora amygdalina, Longicatena caecimuris, Megasphaera massiliensis, Merdimmobilis hominis, Monoglobus pectinilyticus, Neglecta timonensis, Phascolarctobacterium faecium, Roseburia faecis, Roseburia hominis, Ruminococcus bromii, Ruminococcus faecis, Ruthenibacterium lactatif ormans,25 Turicibacter sanguinis, Parasutterella excrementihominis, Sutterella massiliensis, Sutterella wadsworthensis, Bilophila wadsworthia, Akkermansia muciniphila, or a functional equivalent thereof; (g) FBI00001, FBI00002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033, FBI00034, FBI00043, FBI00044, FBI00048, FBI00050, FBI00051, FBI00057, FBI00059,FBI00060, FBI00070, FBI00071, FBI00076, FBI00079, FBI00087, FBI00093, FBI00102,FBI00109, FBI00117, FBI00120, FBI00125, FBI00127, FBI00128, FBI00145, FBI00162,FBI00174, FBI00184, FBI00190, FBI00191, FBI00194, FBI00198, FBI00199, FBI00200,FBI00201, FBI00205, FBI00206, FBI00211, FBI00220, FBI00221, FBI00236, FBI00245,FBI00248, FBI00251, FBI00254, FBI00267, FBI00278, FBI00288, FBI00290, FBI00004,FBI00012, FBI00015, FBI00018, FBI00019, FBI00021, FBI00038, FBI00040, FBI00046,35 FBI00061, FBI00066, FBI00075, FBI00077, FBI00080, FBI00081, FBI00085, FBI00092,ACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT FBI00097, FBI00099, FBI00112, FBI00132, FBI00137, FBI00140, FBI00149, FBI00151,FBI00176, FBI00189, FBI00197, FBI00208, FBI00212, FBI00224, FBI00226, FBI00229,FBI00233, FBI00235, FBI00237, FBI00243, FBI00244, FBI00258, FBI00260, FBI00263,FBI00270, FBI00273, FBI00277, FBI00292, FBI00009, FBI00011, FBI00016, FBI00020,5 FBI00025, FBI00027, FBI00030, FBI00047, FBI00052, FBI00053, FBI00056, FBI00062,FBI00078, FBI00096, FBI00104, FBI00110, FBI00111, FBI00113, FBI00115, FBI00116,FBI00123, FBI00124, FBI00126, FBI00135, FBI00147, FBI00159, FBI00167, FBI00170,FBI00232, FBI00255, FBI00271, FBI00022, FBI00049, FBI00068, FBI00069, FBI00152,FBI00165, FBI00171, FBI00175, FBI00177, FBI00180, FBI00182, FBI00238, FBI00269,10 FBI00274, and FBI00281, or a functional equivalent thereof; (h) FBI00001, FB 100002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033, FBI00034, FBI00043, FBI00044,FBI00048, FBI00050, FBI00051, FBI00057, FBI00059, FBI00060, FBI00070, FBI00071,FBI00076, FBI00079, FBI00087, FBI00093, FBI00102, FBI00109, FBI00117, FBI00120,FBI00125, FBI00127, FBI00128, FBI00145, FBI00162, FBI00174, FBI00184, FBI00190,FBI00191, FBI00194, FBI00198, FBI00199, FBI00200, FBI00201, FBI00205, FBI00206,FBI00211, FBI00220, FBI00221, FBI00236, FBI00245, FBI00248, FBI00251, FBI00254,FBI00267, FBI00278, FB 100288, and FBI00290 or a functional equivalent thereof; (i) FBI00004, FBI00012, FBI00015, FBI00018, FBI00019, FBI00021, FBI00038, FBI00040, FBI00046,FBI00061, FBI00066, FBI00075, FBI00077, FBI00080, FBI00081, FBI00085, FBI00092,20 FBI00097, FBI00099, FBI00112, FBI00132, FBI00137, FBI00140, FBI00149, FBI00151,FBI00176, FBI00189, FBI00197, FBI00208, FBI00212, FBI00224, FBI00226, FBI00229,FBI00233, FBI00235, FBI00237, FBI00243, FBI00244, FBI00258, FBI00260, FBI00263,FBI00270, FB 100273, FB 100277, and FBI00292, or a functional equivalent thereof; (j) FBI00009, FBI00011, FBI00016, FBI00020, FBI00025, FBI00027, FBI00030, FBI00047, FBI00052,FBI00053, FBI00056, FBI00062, FBI00078, FBI00096, FBI00104, FBI00110, FBI00111,FBI00113, FBI00115, FBI00116, FBI00123, FBI00124, FBI00126, FBI00135, FBI00147,FBI00159, FBI00167, FBI00170, FBI00232, FBI00255, and FBI00271, or a functional equivalent thereof; or (k) FBI00022, FBI00049, FBI00068, FBI00069, FBI00152, FBI00165, FBI00171, FBI00175, FBI00177, FBI00180, FBI00182, FBI00238, FBI00269, FBI00274, and FBI00281, or30 a functional equivalent thereof.In certain embodiments, the microbial consortium comprises the plurality of microbes set forth in Figures 5 A-5C. In certain embodiments, the microbial consortium consists of the plurality of microbes set forth in Figures 5A-5C. In certain embodiments, the microbial consortium comprises the plurality of microbes comprising strains of the microbes set forth in Figure 11. InACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT certain embodiments, the microbial consortium consists of the plurality of microbes consisting of strains of the microbes set forth in Figure 11.In certain embodiments, the immune-related adverse event is a gastrointestinal toxicity, a dermatologic toxicity, a hepatotoxicity, an endocrinopathy, pneumonitis, arthralgia, arthritis,5 nephritis, a cardiotoxicity, neurological toxicity, or a hematologic toxicity, or combinations thereof. In certain embodiments, the phenotype associated with the immune-related adverse event is impaired intestinal barrier integrity. In certain embodiments, the phenotype associated with the immune-related adverse event is due to altered absolute abundance levels of short chain fatty acids (SCFAs) or altered relative abundance levels of SCFAs. In certain embodiments, the phenotype10 associated with the immune-related adverse event is due to altered absolute abundance levels of conjugated bile acids, primary bile acids, secondary bile acids or altered relative abundance levels of the bile acid pool. In certain embodiments, the immune-related adverse event is colitis. In certain embodiments, the phenotype associated with colitis is abdominal pain, bloated stomach, diarrhea, blood in the stool, loss of appetite, weight loss, vomiting, or fever.In certain embodiments, (a) the phenotype associated with the dermatologic toxicity is a rash, pruritus, or vitiligo; (b) the phenotype associated with the hepatotoxicity is hepatitis; (c) the phenotype associated with the endocrinopathy is an inflammation of an endocrine gland; (d) the phenotype associated with the pneumonitis is cough, shortness of breath or chest pain; (e) the phenotype associated with the arthralgia or arthritis is joint pain or inflammation mimicking autoimmune arthritis; (f) the phenotype associated with the cardiotoxicity is inflammation of the heart muscle (e.g., myocarditis) or the lining around the heart (e.g., pericarditis); (g) the phenotype associated with the neurological toxicity is peripheral neuropathy, nerve damage, myasthenia gravis, or neuromuscular disorder; and (h) the phenotype associated with the hematologic toxicity is immune thrombocytopenia or hemolytic anemia.25 In certain embodiments, the immunotherapy comprises an immune checkpoint inhibitor (ICI). In certain embodiments, the ICI comprises an anti-PDl antibody, an anti-PD-Ll antibody, an anti-CTLA-4 antibody, an anti-BTLA antibody, an anti-TIM3 antibody, an anti-LAG-3 antibody, or a combination thereof. In certain embodiments, the ICI comprises an anti-PDl antibody and an anti-CTLA-4 antibody. In certain embodiments, the anti-PDl antibody comprises pembrolizumab, nivolumab, cemiplimab, dostarlimab, retifanlimab-dlwr, and tislelizumab, or combinations thereof. In certain embodiments, the anti-PD-Ll antibody comprises atezolizumab, avelumab, durvalumab, or a combination thereof. In certain embodiments, the anti-CTL4 antibody comprises ipilimumab or tremelimumab, or a combination thereof. In certain embodiments, the microbial consortium or a pharmaceutical composition thereof comprises35 between about 1 x 107and about 1 x 1013viable cells, between about 1 x 108and about 1 x 1Q13ACTIVE 511662979.2 16PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT viable cells, between about 1 x 109and about 1 x 1013viable cells, between about 1 x io10and about 1 x 1013viable cells, between about 1 x io11and about 1 x io13viable cells, between about1 x io12and about 1 x io13viable cells, between about 1 x io7and about 1 x io12viable cells, between about 1 x io7and about 1 x io11viable cells, between about 1 x io7and about 1 x io105 viable cells, between about 1 x io7and about 1 x io9viable cells, between about 1 x io7and about 1 x io8viable cells, between about 1 x 108and about 1 x io9viable cells, between about 1 x 109and about 1 x io10viable cells, between about 1 x io11and about 1 x io12viable cells, between about 1 x io12and about 1 x io13viable cells, between about 5 x io9and about 5 x io10viable cells, between about 5 x io10and about 5 x io11viable cells, or between about 5 x io11and10 about 5 x io12viable cells.In certain embodiments, the microbial consortium or a pharmaceutical composition thereof comprises up to about 1011viable cells or up to about 1012viable cells. In certain embodiments, the method comprises administering a loading dose and one or more maintenance doses of the microbial consortium or a pharmaceutical composition thereof. In certain embodiments, the loading dose is administered before, after, or at the same time as the immunotherapy. In certain embodiments, the loading dose is administered 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days before the immunotherapy. In certain embodiments, the loading dose is administered 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days after the immunotherapy. In certain embodiments, the loading dose is administered at the same time as the immunotherapy. In certain embodiments, the loading dose is administered for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days. In certain embodiments, the loading dose is administered for 2-3 days, 3-5 days, 4-6 days, or 5-7 days. In certain embodiments, the one or more maintenance doses are administered for at least 21 days, at least 1 month, at least 2 months, at least 4 months, at least 6 months, at least 8 months, at least 1025 months, at least 12 months, at least 18 months, or at least 24 months following the last loading dose. In certain embodiments, the loading dose comprises about 1012viable cells.In certain embodiments, the loading dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise about 1011viable cells. In certain embodiments, the loading dose comprises 10 coated enteric capsules. In certain embodiments, the loading dose is administered for 1 day. In certain embodiments, the loading dose is administered twice a day. In certain embodiments, the maintenance dose comprises about2 x io11viable cells. In certain embodiments, each maintenance dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise about 1011viable cells. In certain embodiments, each maintenance dose comprises 2 coated35 enteric capsules. In certain embodiments, the maintenance doses are administered for 2 days, 3ACTIVE 511662979.2 17PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 10 weeks, or 12 weeks following the last loading dose. In certain embodiments, the microbial consortium or pharmaceutical composition thereof is present in a food product, a probiotic, a prebiotic, or a combination thereof. In certain5 embodiments, the microbial consortium or pharmaceutical composition is administered orally or rectally. In certain embodiments, the microbial consortium or pharmaceutical composition is administered via colonoscope.BRIEF DESCRIPTION OF THE DRAWINGSFigure 1 shows a schematic illustrating the manufacturing of the presently disclosed10 microbial consortia and currently available fecal material transfer protocol.Figure 2 shows phylogenetic analysis and selection of the microbes in KAN-004.Figure 3 shows histological samples and survival plots of animals treated with KAN-004, which drastically improved intestinal barrier integrity in the setting of severe colitis.Figures 4A and 4B show the effects of KAN-004 on short chain fatty acid diversity (Figure 4A) and bile acid diversity (Figure 4B).Figures 5A-5C show a table summarizing the sequence identifiers (SEQ ID NO) of the 16s rRNA of the strains and species of the microbial consortia disclosed in Table 1 below. Figures 5A-5C include alternative names of the species of the microbial consortia disclosed herein.Figure 6 shows the impact of KAN-004 on the therapeutic response to immune checkpoint20 inhibitor (ICI) therapy relative to control in a C57BL / 6 germ-free (GF) MCA205 fibrosarcoma mouse model.Figures 7A-7C shows results of the MCA205 mouse model study where tumor growth was observed to reach an average of -100 mm3 in the KAN-004 treated MCA205 model, whereas tumor growth was observed to reach an average of >150 mm3 in the positive control benchmark responder treated mice (Figure 7A), the KAN-004 treated mice had smaller average tumor volumes throughout the study, including on day +6, which is the first time that mice were provided anti-PDl (Figure 7B), and both the KAN-004 treated mice and the control mice maintained consistent weight throughout the study (Figure 7C) .Figure 8A-8B show the assay parameters used to investigate KAN-004 and its potential to30 induce PD-1 sensitivity in the EO771 cell line in a specific pathogen-free (SPF) mouse model.Figures 9A-9C shows results of the SPF E0771 mouse model study where KAN-004 treated animals were found to have lower tumor volumes than mice treated with non-responder (NR) or responder (R) or receiving no treatment (Figure 9A), the anti-PD-l / KAN-004 cotreatment group showed significantly smaller tumor volumes than the isotype control with KAN-ACTIVE 511662979.2 18PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT 004 (Figure 9B), and that body weight measurements were indistinguishable between the study groups, increasing over the study as expected after an antibiotics course, from 16 to 20 g / mouse (Figure 9C).Figure 10 shows the results of immune cell profile assays for the tumors harvested from5 the SPF E0771 mouse model study with an increased ratio of CD8 / Treg, an increased CD8+ % and an increased CD8+ effector memory T cell (TEM) population relative to the non-responder FMT control being observed.Figure 11 shows the species and each of the NCBI Tax IDs that correlate to such species in the microbial consortia disclosed in Table 1.10 DETAILED DESCRIPTIONThe present disclosure relates to compositions and methods for engrafting a microbial consortia disclosed herein. The present disclosure is based, in part, on the discovery that the presently disclosed microbial consortia are capable of effectively engrafting in a subject that has received or will receive an immunotherapy, e.g., an immune checkpoint inhibitor (ICI). In certain embodiments, the presently disclosed microbial consortia treat or prevent immune-related adverse effects (AEs), such as colitis, associated with immunotherapy treatment, e.g., treatment with an ICI. In certain embodiments, treatment with the microbial consortia ameliorates one or more phenotypes associated with an immune-related adverse event, such as colitis, in a subject undergoing immunotherapy. In certain embodiments, treatment with the microbial consortia20 ameliorates one or more phenotypes associated with an immune-related adverse event, such as colitis, in a subject having undergone immunotherapy. Examples of such phenotypes include, but are not limited to, impaired intestinal barrier integrity, reduced short chain fatty acids (SCFAs) level, and reduced bile acid diversity.Additionally or alternatively, in certain embodiments, the presently disclosed microbial consortia treat or prevent diarrhea and / or colitis.Non-limiting embodiments of the presently disclosed subject matter are described by the present specification and Examples. / . DefinitionsUnless defined otherwise, all technical and scientific terms used herein have the meaning30 commonly understood by a person skilled in the art. The following references provide one of skill with a general definition of many of the terms used in the presently disclosed subject matter: Singleton et al., Dictionary of Microbiology and Molecular Biology (2nd ed. 1994); The Cambridge Dictionary of Science and Technology (Walker ed., 1988); The Glossary of Genetics,ACTIVE 511662979.2 19PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT 5th Ed., R. Rieger et al. (eds.), Springer Verlag (1991); and Hale & Marham, The Harper Collins Dictionary of Biology (1991). As used herein, the following terms have the meanings ascribed to them below, unless specified otherwise.It is understood that aspects and embodiments of the present disclosure described herein5 include “comprising,” “consisting,” and “consisting essentially of’ aspects and embodiments. The terms “comprises” and “comprising” are intended to have the broad meaning ascribed to them in U.S. Patent Law and can mean “includes,” “including” and the like. To facilitate an understanding of the present disclosure, a number of terms and phrases are defined below.The term “a” and “an” as used herein mean “one or more” and include the plural unless10 the context is appropriate.As used herein, the term “microbe” or “microbiota” refers to a microbial organism including, but not limited to, bacteria, archaea, protozoa, and unicellular fungi.As used herein, the term “active microbes” refers to microbes that express sufficient amounts of one or more metabolic enzymes to metabolize a substrate that causes or contributes to change in an animal. In certain embodiments, “active microbes” express sufficient amounts of one or more metabolic enzymes to metabolize a substrate that causes or contributes to disease in an animal.As used herein, the term “supportive community” refers to one or more microbial strains that, when administered with an active microbe, enhance one or more characteristics of the active20 microbe selected from the group consisting of gastrointestinal engraftment, biomass, metabolic substrate metabolism, and longitudinal stability.As used herein, the term “synthesizing microbe” refers to a microbe that expresses sufficient amounts of one or more enzymes to catalyze the combination of one or more metabolites produced by an active microbe, and one or more fermentation products produced by a fermenting microbe in a gastrointestinal niche.As used herein, the term “fermenting microbe” refers to a microbe that expresses sufficient amounts of one or more enzymes to catalyze a fermentation reaction in a gastrointestinal niche.As used herein, the term “longitudinal stability” refers to the ability of one or more microbes, or microbial consortia, to remain engrafted and metabolically active in one of more than30 one niche of the gastrointestinal tract despite transient or long-term environmental changes to the gastrointestinal niche.As used herein, the term “metabolism,” “metabolize,” “metabolization,” or variants thereof refers to the biochemical conversion of a metabolic substrate to a metabolic product. In certain embodiments, metabolization includes isomerization.ACTIVE 511662979.2 20PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENTAs used herein, the term “biomass,” refers to the total mass of one or more microbes, or consortia, in a given area or volume.As used herein, the terms “microbial consortia” and “microbial consortium” are used interchangeably and refer to a mixture of two or more isolated microbial strains that are expanded5 in culture, wherein one microbial strain in the mixture has a beneficial or desired effect on another microbial strain in the mixture.As used herein, the term “Consortia” is used as a capitalized term to refer to one or more of the microbial consortia described herein.As used herein, the term “gastrointestinal engraftment” or “engraft” or “engraftment”10 refers to the establishment of one or more microbes, or microbial consortia, in one or more niches of the gastrointestinal tract that, prior to administration of the one or more microbes, or microbial consortia, lacks the one or more microbes, or microbial consortia. For clarity, engraftment refers to the engraftment of one or more microbes administered to a subject. In certain embodiments, the gastrointestinal engraftment can be transient. In certain embodiments, the gastrointestinal engraftment can be persistent.As used herein, the term “pharmaceutical composition” refers to the combination of an active agent with a carrier, inert or active, making the composition especially suitable for therapeutic use in vivo or ex vivo.As used herein, the term “pharmaceutically acceptable carrier” refers to any of the standard pharmaceutical carriers, such as phosphate buffered saline solution, water, emulsions (e.g., such as oil / water or water / oil emulsions), and various types of wetting agents. The compositions also can include stabilizers and preservatives. For examples of carriers, stabilizers, and adjuvants, see e.g., Martin, Remington’s Pharmaceutical Sciences, 15thEd. Mack Publ. Co., Easton, PA

[1975] ,As used herein, the term “effective amount” refers to an amount sufficient to achieve a25 beneficial or desired result. In certain non-limiting embodiments, an effective amount can be an amount that results in improved gastrointestinal engraftment (e.g., engraftment of one or more of the plurality of active microbes), increased biomass (e.g., of one or more of the plurality of active microbes), increased metabolism, or improved longitudinal stability.As used herein, “significantly” or “significant” refers to a change or alteration in a measurable parameter to a statistically significant degree as determined in accordance with an appropriate statistically relevant test. For example, in certain non-limiting embodiments, a change or alteration is significant if it is statistically significant in accordance with, e.g. , a Student’ s t-test, chi-square, or Mann Whitney test.As used herein, the term “subject” refers to an organism to be treated by the microbial35 consortium and compositions described herein. Such organisms preferably include, but are notACTIVE 511662979.2 21PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT limited to, mammals (e.g., murines, simians, equines, bovines, porcines, canines, felines, and the like), and more preferably include humans.The term percent “identity” or “sequence identity,” in the context of two or more nucleic acid or polypeptide sequences, refer to two or more sequences or subsequences that have a5 specified percentage of nucleotides or amino acid residues that are the same, when compared and aligned for maximum correspondence, as measured using one of the sequence comparison algorithms described below (e.g., BLASTP and BLASTN or other algorithms available to persons of skill) or by visual inspection. Depending on the application, the percent “identity” can exist over a region of the sequence being compared, e.g., over a functional domain, or, alternatively,10 exist over the full length of the two sequences to be compared.For sequence comparison, typically one sequence acts as a reference sequence to which test sequences are compared. When using a sequence comparison algorithm, test and reference sequences are input into a computer, subsequence coordinates are designated, if necessary, and sequence algorithm program parameters are designated. The sequence comparison algorithm then calculates the percent sequence identity for the test sequence(s) relative to the reference sequence, based on the designated program parameters.Optimal alignment of sequences for comparison can be conducted, e.g., by the local homology algorithm of Smith & Waterman, Adv. Appl. Math. 2:482 (1981), by the homology alignment algorithm of Needleman & Wunsch, J. Mol. Biol. 48:443 (1970), by the search for similarity method of Pearson & Lipman, Proc. Nat’l. Acad. Sci. USA 85:2444 (1988), by computerized implementations of these algorithms (GAP, BESTFIT, FASTA, and TFASTA in the Wisconsin Genetics Software Package, Genetics Computer Group, 575 Science Dr., Madison, Wis.), or by visual inspection (see generally Ausubel et al., infra).One example of an algorithm that is suitable for determining percent sequence identity and25 sequence similarity is the BLAST algorithm, which is described in Altschul et al., J. Mol. Biol. 215:403-410 (1990). Software for performing BLAST analyses is publicly available through the National Center for Biotechnology Information (www.ncbi.nlm.nih.gov / ).When used in reference to 16S rRNA sequences, a “sequence identity” of at least 97% indicates that two microbial strains are likely to belong to the same species, whereas 16S rRNA sequences having less than 97% sequence identity indicate that two microbial strains likely belong to different species, and 16S rRNA sequences having less than 95% sequence identity indicates that two microbial strains likely belong to distinct genera (Stackebrandt E., and Goebel, B.M., Int J Syst Bact, 44 (1994) 846-849.).As used herein, the terms “functional equivalent” or “functionally equivalent” refers to35 microbes, microbial consortia, and compositions that share similar or identical role (e.g.,ACTIVE 511662979.2 22PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT metabolism of oxalate). For example, without any limitation, two different microbial consortia that can catalyze high concentration of oxalate are functional equivalent to each other. In certain non-limiting embodiments, a microbe, a microbial consortium, and a composition that is functional equivalent can be based on the characteristic outlined in Table 3 (see Example section).5 As used herein, the term “probiotic” refers to live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. Further information on probiotics can be found in Hill et al., Nature reviews Gastroenterology & hepatology 11.8 (2014): 506-514.Throughout the description, where compositions are described as having, including, or comprising specific components, or where processes and methods are described as having, including, or comprising specific steps, it is contemplated that, additionally, there are compositions of the present disclosure that consist essentially of, or consist of, the recited components, and that there are processes and methods according to the present disclosure that consist essentially of, or consist of, the recited processing steps.15 As a general matter, compositions specifying a percentage are by weight unless otherwise specified. Further, if a variable is not accompanied by a definition, then the previous definition of the variable controls.2. Methods of TreatingIn certain non-limiting embodiments, the present disclosure provides Consortia capable of20 engrafting into one or more niche of a gastrointestinal tract where it is capable of reducing, inhibiting, preventing and / or treating immune-related adverse events associated with immunotherapy treatment in an animal. In certain embodiments, the animal is a human.In certain non-limiting embodiments, the present disclosure provides Consortia capable of engrafting into one or more niche of a gastrointestinal tract where it is capable of reducing, inhibiting, preventing and / or treating diarrhea and / or colitis associated with immunotherapy treatment in an animal. In certain embodiments, the animal is a human.In certain non-limiting embodiments, the present disclosure provides Consortia capable of engrafting into one or more niche of a gastrointestinal tract where it is capable of reducing, inhibiting, preventing and / or treating diarrhea and / or colitis . In certain embodiments, the animal30 is a human.2.1. Methods of Treating Immune-Related Adverse Events Associatedwith Immune CheckpointInhibitors TherapiesACTIVE 511662979.2 23PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT The present disclosure provides Consortia capable of engrafting into one or more niche of a gastrointestinal tract where it is capable of reducing, inhibiting, preventing and / or treating immune-related adverse events associated with immunotherapy treatment in an animal. In certain embodiments, the animal is a human.5 Immune-related adverse events (AEs) are side effects and toxi cities (e.g., autoimmune conditions) that can affect any organ of the animal after administration of immune checkpoint inhibitors (ICI). AEs can occur at any time during the treatment and generally, but not exclusively, appear in the first 3 months of treatment. Notably, subjects with AEs are treated with glucocorticoids, which are known to be potent immunosuppressors.10 Non-limiting examples of AEs toxicities include dermatologic toxicities (e.g., skin-related side effects, e.g., rash, pruritus (itching), vitiligo, etc.), gastrointestinal toxicities (e.g., colitis, diarrhea, abdominal pain, etc.), hepatotoxicities (e.g., hepatitis), endocrinopathies (e.g., inflammation of endocrine glands, e.g., thyroiditis, thyroid inflammation, hypophysitis, pituitary gland inflammation, adrenal insufficiency, diabetes mellitus, etc.), pneumonitis (e.g., inflammation of the lungs, which can cause symptoms like cough, shortness of breath, and chest pain), arthralgia and arthritis (i.e., joint pain and inflammation mimicking autoimmune arthritis), nephritis (i.e., kidney inflammation leading to reduced kidney function and elevated creatinine levels), cardiotoxicity (i.e., inflammation of the heart muscle (e.g., myocarditis) or the lining around the heart (e.g., pericarditis)), neurological toxicities (e.g., peripheral neuropathy, nerve damage, myasthenia gravis, neuromuscular disorders, etc.), and hematologic toxicities (e.g., immune thrombocytopenia, hemolytic anemia, etc.). Additional information on AEs can be found in Barron et al., Journal for immunotherapy of cancer (2023).In certain non-limiting embodiments, the present disclosure provides methods for preventing and / or treating AEs in a subject that has received or will receive an immunotherapy25 including an immune checkpoint inhibitor (ICI). In certain embodiments, the methods can comprise administering an effective amount of a Consortia or a pharmaceutical composition thereof disclosed herein. In certain embodiments, the Consortia is KAN-004 or a functional equivalent thereof. In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in the engraftment of the microbes of the Consortia. Surprisingly, the administration of the Consortia does not interfere with the response to immune checkpoint inhibitor (ICI) therapy.In certain embodiments, the presently disclosed microbial consortia treats or prevents AEs associated with immunotherapy treatment, e.g., treatment with an ICI. In certain embodiments, treatment with the microbial consortia ameliorates one or more symptoms associated with AEs in35 a subject undergoing immunotherapy. For example, but without any limitation, the microbialACTIVE 511662979.2 24PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT consortia ameliorates hypothyroidism, hyperthyroidism, pneumonitis, vitiligo, ALT increase, rhabdomyolysis, diarrhea, rashes, dermatitis, and the like. In certain embodiments, treatment with the microbial consortia ameliorates one or more phenotypes in a subject undergoing immunotherapy. In certain embodiments, the phenotype ameliorated is impaired intestinal barrier5 integrity. In certain embodiments, the phenotype associated with the immune-related adverse event is due to altered absolute abundance levels of short chain fatty acids (SCFAs) or altered relative abundance levels of SCFAs. In certain embodiments, the phenotype ameliorated is reduced levels of short chain fatty acids (SCFAs) (e.g., in the gastrointestinal tract of the subject) or altered SCFA diversity. In certain embodiments, the administration of the Consortia or10 pharmaceutical composition thereof results in increase of short chain fatty acids (SCFAs) (e.g., in the gastrointestinal tract of the subject). In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in restoration of short chain fatty acids (SCFAs) (e.g., in the gastrointestinal tract of the subject).In certain embodiments, the phenotype associated with the immune-related adverse event is due to altered absolute abundance levels of conjugated bile acids, primary bile acids, secondary bile acids or altered relative abundance levels of the bile acid pool. In certain embodiments, the phenotype ameliorated is reduced levels of secondary bile acid acids or altered bile acid diversity. In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in increase in secondary bile acids (e.g., in the gastrointestinal tract of the subject). In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in decrease of bacterial pathogens (e.g., in the gastrointestinal tract of the subject). In certain embodiments, the immune-related adverse event is colitis.In certain embodiments, the present disclosure provides Consortia capable of engrafting into one or more niche of a gastrointestinal tract where it is capable of treating colitis associated25 with immunotherapy treatment in an animal. In certain embodiments, the animal is a human.Colitis is a disorder that characterized by inflammation of the colon, the onset of which can occur in patients who are undergoing immunotherapy treatments. Symptoms associated with colitis can include, for example, abdominal pain, bloated stomach, diarrhea, blood in the stool, loss of appetite, weight loss, vomiting, and fever. The Common Terminology Criteria for Adverse Events (CTACAE) provides further guidance on the symptoms associated with colitis:Grade 1 : Asymptomatic; clinical or diagnostic observations only; intervention not indicated.Grade 2: Abdominal pain; mucus or blood in stool Grade 3 : Severe abdominal pain; peritoneal signs35 Grade 4: Life-threatening consequences; urgent intervention indicatedACTIVE 511662979.2 25PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENTGrade 5 : Death(CTCAE v5.0 - November 27, 2017 (US Dept, of Health and Human Services; NIH; NCI)). The presence of colitis can be determined or confirmed by, for example, a colonoscopy or biopsy of the colon.5 The present disclosure provides methods for preventing and / or treating colitis in a subject that has received or will receive an immunotherapy including an immune checkpoint inhibitor (ICI). In certain embodiments, the methods can comprise administering an effective amount of a Consortia or a pharmaceutical composition thereof disclosed herein. In certain embodiments, the Consortia is KAN-004 or a functional equivalent thereof. In certain embodiments, the10 administration of the Consortia or pharmaceutical composition thereof results in the engraftment of the microbes of the Consortia. Surprisingly, the administration of the Consortia does not interfere with the response to immune checkpoint inhibitor (ICI) therapy.In certain embodiments, the presently disclosed microbial consortia treats or prevents colitis associated with immunotherapy treatment, e.g., treatment with an ICI. In certain embodiments, treatment with the microbial consortia ameliorates one or more phenotype associated with colitis in a subject undergoing immunotherapy. In certain embodiments, the phenotype ameliorated is impaired intestinal barrier integrity. In certain embodiments, the phenotype associated with the immune-related adverse event is due to altered absolute abundance levels of short chain fatty acids (SCFAs) or altered relative abundance levels of SCFAs. In certain embodiments, the phenotype ameliorated is reduced levels of short chain fatty acids (SCFAs) (e.g., in the gastrointestinal tract of the subject) or altered SCFA diversity. In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in increase of short chain fatty acids (SCFAs) (e.g., in the gastrointestinal tract of the subject). In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results25 in restoration of short chain fatty acids (SCFAs) (e.g., in the gastrointestinal tract of the subject).In certain embodiments, the phenotype associated with colitis is due to altered absolute abundance levels of conjugated bile acids, primary bile acids, secondary bile acids or altered relative abundance levels of the bile acid pool. In certain embodiments, the phenotype ameliorated is reduced levels of secondary bile acid acids or altered bile acid diversity. In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in increase in secondary bile acids (e.g., in the gastrointestinal tract of the subject). In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in decrease of bacterial pathogens (e.g., in the gastrointestinal tract of the subject).The present disclosure further provides methods for reducing a severity of at least one35 symptom of colitis in a subject that has received or will receive an immunotherapy including anACTIVE 511662979.2 26PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT immune checkpoint inhibitor (ICI). In certain embodiments, the symptoms reduced are, for example, abdominal pain, bloated stomach, diarrhea, blood in the stool, loss of appetite, weight loss, vomiting, and / or fever.In certain embodiments, KAN-004 or a functional equivalent thereof engraft in the5 gastrointestinal tract of patients. In certain embodiments, KAN-004 or a functional equivalent thereof robustly engraft in the gastrointestinal tract of patients. In certain embodiments, KAN-004 or a functional equivalent thereof engraft in the gastrointestinal tract of patients and restore microbial diversity. In certain embodiments, KAN-004 or a functional equivalent thereof engraft in the gastrointestinal tract of patients and restore key functions of a healthy gut microbiome. In10 certain embodiments, the key functions are 1) increasing microbial diversity, 2) increasing the SCFAs, 3) increasing secondary bile acids, 4) decreasing the presence of bacterial pathogens, and / or 5) promoting heathy barrier responses.In certain embodiments, a Consortia capable of reducing, inhibiting, preventing and / or treating immune-related adverse events associated with immunotherapy treatment (such as colitis) is administered as a single dose or as multiple doses. In certain embodiments, a Consortia is administered once a day for 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, or 1 year. In certain embodiments, a Consortia is administered multiple times daily. In certain embodiments, a Consortia is administered twice daily, three times daily, 4 times daily, or 5 times daily. In certain embodiments, a Consortia is administered intermittently. In certain embodiments, a Consortia is administered once weekly, once monthly, or when a subject is in need thereof. In certain embodiments, the Consortia is KAN-004.In certain embodiments, a Consortia is administered at an effective dose to allow for engraftment and substrate metabolism. In certain embodiments, a Consortia is administered at an25 effective dose to allow for engraftment and significant SCFA production. In certain embodiments, a Consortia is administered at an effective dose to allow for engraftment and reduced inflammation of the gastrointestinal tract.In certain embodiments, a Consortia is administered at a first loading dose and then followed by maintenance doses. In certain embodiments, the first loading dose is administered for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days. In certain embodiments, the loading dose is administered for 1-3 days. In certain embodiments, the loading dose is administered for 2-4 days. In certain embodiments, the loading dose is administered for 2- 3 days. In certain embodiments, the loading dose is administered for 3-5 days. In certain embodiments, the loading dose is administered for 4-6 days. In certain embodiments, the loading35 dose is administered for 5-7 days. In certain embodiments, the loading dose is administered for 1ACTIVE 511662979.2 27PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT day. In certain embodiments, the loading dose is administered for 3 days. In certain embodiments, the loading dose is administered for 2 days.In certain embodiments, the loading dose is administered for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days after the immunotherapy. In certain embodiments,5 the loading dose is administered for 1-3 days after the immunotherapy. In certain embodiments, the loading dose is administered for 2-4 days after the immunotherapy. In certain embodiments, the loading dose is administered for 2-3 days after the immunotherapy. In certain embodiments, the loading dose is administered for 3-5 days after the immunotherapy. In certain embodiments, the loading dose is administered for 4-6 days after the immunotherapy. In certain embodiments,10 the loading dose is administered for 5-7 days after the immunotherapy. In certain embodiments, the loading dose is administered for 1 day after the immunotherapy. In certain embodiments, the loading dose is administered for 3 days after the immunotherapy. In certain embodiments, the loading dose is administered for 2 days after the immunotherapy.In certain embodiments, the loading dose is administered 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10, hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 2 months, 3 months, 4 months, 5 months, 6 months or longer after the onset of one or more phenotypes associated with an immune-related adverse event. In certain embodiments, the loading dose is administered daily for the duration of the immunotherapy administered to the patient.In certain embodiments, the maintenance doses are administered for 5-10 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 7-12 days following the last loading dose. In certain embodiments, the maintenance doses are25 administered for 10-14 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 14-21 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 21-28 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 14 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 21 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 28 days following the last loading dose. In certain embodiments, the maintenance doses are administered for about 8 days following the last loading dose. In certain embodiments, the maintenance doses are administered for about 7 days following the last loading dose. In certain embodiments, the maintenance doses are administered for about 6 days following the last loading35 dose. In certain embodiments, the maintenance doses are administered for about 9 days followingACTIVE 511662979.2 28PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT the last loading dose. In certain embodiments, the maintenance doses are administered for about 10 days following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 21 days following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 1 month following the last loading dose. In certain5 embodiments, the maintenance doses are administered for at least 2 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 4 months following the last loading dose. In certain embodiments, the maintenance doses are administered for the maintenance doses are administered for at least 6 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 810 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 10 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 12 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 18 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 24 months following the last loading dose. In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 6 days (for a total of a 8-day course of treatment). In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 7 days (for a total of a 9-day course of treatment). In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is20 administered for 8 days (for a total of a 10 day course of treatment). In certain embodiments, the loading dose is administered for 9 days and the maintenance dose is administered for 9 days (for a total of a 11 day course of treatment). In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 10 days (for a total of a 12 day course of treatment). In certain embodiments, the Consortia is KAN-004. In certain embodiments, the25 loading dose follows the pretreatment with antibiotics as described in the Combination Therapy section below. In certain embodiments, the loading dose follows the pretreatment with a bowel preparation as described in the Combination Therapy section below. In certain embodiments, the loading dose follows the pretreatment with antibiotics and a bowel preparation as described in the Combination Therapy section below.When used in the context of preventing the onset of one or more phenotypes associated with an immune-related adverse event in a patient that will receive an immunotherapy including an immune checkpoint inhibitor (ICI), a Consortia is administered loading dose before, after, or at the same time as the immunotherapy. In certain embodiments, loading dose is administered 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days before the35 immunotherapy. In certain embodiments, the loading dose is administered 1 day, 2 days, 3 days,ACTIVE 511662979.2 29PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days after the immunotherapy. In certain embodiments, the loading dose is administered at the same time as the immunotherapy. In certain embodiments, the first loading dose is administered for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days. In certain embodiments, the loading dose is administered5 for 1-3 days. In certain embodiments, the loading dose is administered for 2-4 days. In certain embodiments, the loading dose is administered for 2-3 days. In certain embodiments, the loading dose is administered for 3-5 days. In certain embodiments, the loading dose is administered for 4- 6 days. In certain embodiments, the loading dose is administered for 5-7 days. In certain embodiments, the loading dose is administered for 1 day. In certain embodiments, the loading10 dose is administered for 3 days. In certain embodiments, the loading dose is administered for 2 days. In certain embodiments, the maintenance doses are administered for 5-10 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 7-12 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 10-14 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 14-21 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 21-28 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 14 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 21 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 28 days following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 21 days following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 1 month following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 2 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 425 months following the last loading dose. In certain embodiments, the maintenance doses are administered for the maintenance doses are administered for at least 6 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 8 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 10 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 12 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 18 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 24 months following the last loading dose. In certain embodiments, the maintenance doses are administered for about 8 days following the last loading dose. In certain embodiments, the35 maintenance doses are administered for about 7 days following the last loading dose. In certainACTIVE 511662979.2 30PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT embodiments, the maintenance doses are administered for about 6 days following the last loading dose. In certain embodiments, the maintenance doses are administered for about 9 days following the last loading dose. In certain embodiments, the maintenance doses are administered for about 10 days following the last loading dose. In certain embodiments, the loading dose is administered5 for 2 days and the maintenance dose is administered for 6 days (for a total of a 8-day course of treatment). In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 7 days (for a total of a 9-day course of treatment). In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 8 days (for a total of a 10 day course of treatment). In certain embodiments, the10 loading dose is administered for 9 days and the maintenance dose is administered for 9 days (for a total of a 11 day course of treatment). In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 10 days (for a total of a 12 day course of treatment). In certain embodiments, the Consortia is KAN-004. In certain embodiments, the loading dose follows the pretreatment with antibiotics as described in the Combination Therapy section below. In certain embodiments, the loading dose follows the pretreatment with a bowel preparation as described in the Combination Therapy section below. In certain embodiments, the loading dose follows the pretreatment with antibiotics and a bowel preparation as described in the Combination Therapy section below.In certain embodiments, a Consortia is administered at a loading dose and then followed20 by maintenance doses. In certain embodiments, the loading dose comprises about 1012viable cells. In certain embodiments, the loading dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise about 1011viable cells. In certain embodiments, the loading dose comprises 10 coated enteric capsules. In certain embodiments, the loading dose is administered for 1 day. In certain embodiments, the loading25 dose is administered twice a day. In certain embodiments, the maintenance dose comprises about2 x io11viable cells. In certain embodiments, each maintenance dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise about 1011viable cells. In certain embodiments, each maintenance dose comprises 2 coated enteric capsules. In certain embodiments, the maintenance doses are administered for 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks,3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 10 weeks, or 12 weeks following the last loading dose.In certain embodiments, KAN-004 is formulated by blending the lyophilized microbial species (e.g., depicted in Figures 5A-5A and 11) and filling them into coated enteric capsules. In35 certain embodiments, the capsules of KAN-004 are provided in blister packaging or alternativeACTIVE 511662979.2 31PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT packaging to allow for no or low oxygen exposure (e.g., packaging to sustain the viability of anaerobic microbes). In certain embodiments, each capsule contains a range of 5 * 1010to 5 * 1011viable cells / capsule. In certain embodiments, each capsule contains a range of 5 * 109to 5 * 1010viable cells / capsule. In certain embodiments, each capsule contains a range of 5 * 1011to 5 * 10125 viable cells / capsule. In certain embodiments, KAN-004 is orally dosed at up to 1012viable cells on Days 1 and 2, and up to 1011viable cells on Days 3 to 10. In certain embodiments, maltodextrin is included as an excipient in the capsules.In certain embodiments, each capsule of KAN-004 contains a range of 5 * 1010to 5 * 1011viable cells / capsule and a viable cell count basis and with relative abundance values of the 14510 strains ranging from 18% to 0.015%.In certain embodiments, KAN-004 is formulated by blending the four lyophilized DSs containing the 145 microbial species and filling them into coated enteric capsules. In certain embodiments, the capsules of KAN-004 are provided in blister packaging or alternative packaging to allow for no or low oxygen exposure (e.g., packaging to sustain the viability of anaerobic microbes). In certain embodiments, each capsule contains a range of 5 * 1010to 5 * 1011viable cells / capsule. In certain embodiments, each capsule contains a range of 5 * 109to 5 * 1010viable cells / capsule. In certain embodiments, each capsule contains a range of 5 * 1011to 5 * 1012viable cells / capsule. In certain embodiments, KAN-004 is orally dosed at up to 1012viable cells on Days 1 and 2, and up to 1011viable cells on Days 3 to 10. In certain embodiments, maltodextrin is included as an excipient in the capsules.In certain embodiments, each capsule of KAN-004 contains a range of 5 * 1010to 5 * 1011viable cells / capsule and a viable cell count basis and with relative abundance values of the 145 strains ranging from 18% to 0.015%.In certain embodiments, the methods disclose herein comprise diagnosing an immune-25 related adverse event in a subject and then treating the subject with the Consortia or pharmaceutical composition thereof. For example, but not by way of limitation, a method of treating a subject having an immune-related adverse event can include (a) diagnosing the subject with the immune-related adverse event and (b) administering an effective amount of a Consortia (e.g., KAN-004) or pharmaceutical composition thereof to the subject. In certain embodiments, the immune-associated adverse event is colitis. In certain embodiments, the method for diagnosing colitis includes organic acid test, comprehensive digestive stool analysis (CDSA), hydrogen breath test, or a combination thereof.In certain embodiments, a Consortia can be administered via an enteric route. For example, in certain non-limiting embodiments, a microbial consortium is administered orally,35 rectally (e.g., by enema, suppository, or colonoscope), or by oral or nasal tube.ACTIVE 511662979.2 32PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT In certain embodiments, a Consortia is administered orally. In certain embodiments the oral administration is by a powder. In certain embodiments the oral administration is by a slurry. In certain embodiments the oral administration is by pills or capsules.In certain embodiments, a Consortia can be administered to a specific location along the5 gastrointestinal tract. For example, in certain non-limiting embodiments, a microbial consortium can be administered into one or more gastrointestinal location including the mouth, esophagus, stomach, small intestine (duodenum, jejunum, ileum), large intestine (cecum, ascending colon, transverse colon, descending colon), or rectum. In certain embodiments, a microbial consortium can be administered in all regions of the gastrointestinal tract.10 In certain embodiments, KAN-004 can be administered orally via a pill or capsule.2. . Methods of Treating Immune-Related Diarrhea and / or ColitisThe present disclosure provides Consortia capable of engrafting into one or more niche of a gastrointestinal tract where it is capable of reducing, inhibiting, preventing and / or treating immune-related diarrhea and / or colitis in an animal. In certain embodiments, the animal is a human.In certain embodiments, the methods can comprise administering an effective amount of a Consortia or a pharmaceutical composition thereof disclosed herein. In certain embodiments, the Consortia is KAN-004 or a functional equivalent thereof. In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in the engraftment20 of the microbes of the Consortia.In certain embodiments, the presently disclosed microbial consortia treats or prevents immune-related colitis. In certain embodiments, treatment with the microbial consortia ameliorates one or more phenotype associated with immune-related colitis in a subject. In certain embodiments, the phenotype ameliorated is impaired intestinal barrier integrity. In certain embodiments, the phenotype associated with the immune-related adverse event is due to altered absolute abundance levels of short chain fatty acids (SCFAs) or altered relative abundance levels of SCFAs. In certain embodiments, the phenotype ameliorated is reduced levels of short chain fatty acids (SCFAs) (e.g., in the gastrointestinal tract of the subject) or altered SCFA diversity. In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof30 results in increase of short chain fatty acids (SCFAs) (e.g., in the gastrointestinal tract of the subject). In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in restoration of short chain fatty acids (SCFAs) (e.g., in the gastrointestinal tract of the subject).ACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT In certain embodiments, the phenotype associated with colitis is due to altered absolute abundance levels of conjugated bile acids, primary bile acids, secondary bile acids or altered relative abundance levels of the bile acid pool. In certain embodiments, the phenotype ameliorated is reduced levels of secondary bile acid acids or altered bile acid diversity. In certain5 embodiments, the administration of the Consortia or pharmaceutical composition thereof results in increase in secondary bile acids (e.g., in the gastrointestinal tract of the subject). In certain embodiments, the administration of the Consortia or pharmaceutical composition thereof results in decrease of bacterial pathogens (e.g., in the gastrointestinal tract of the subject).The present disclosure further provides methods for reducing a severity of at least one10 symptom of immune-related colitis in a subject. In certain embodiments, the symptoms reduced are, for example, abdominal pain, bloated stomach, diarrhea, blood in the stool, loss of appetite, weight loss, vomiting, and / or fever.In certain embodiments, KAN-004 or a functional equivalent thereof engraft in the gastrointestinal tract of patients. In certain embodiments, KAN-004 or a functional equivalent thereof robustly engraft in the gastrointestinal tract of patients. In certain embodiments, KAN-004 or a functional equivalent thereof engraft in the gastrointestinal tract of patients and restore microbial diversity. In certain embodiments, KAN-004 or a functional equivalent thereof engraft in the gastrointestinal tract of patients and restore key functions of a healthy gut microbiome. In certain embodiments, the key functions are 1) increasing microbial diversity, 2) increasing the SCFAs, 3) increasing secondary bile acids, 4) decreasing the presence of bacterial pathogens, and / or 5) promoting heathy barrier responses.In certain embodiments, a Consortia capable of reducing, inhibiting, preventing and / or treating diarrhea and / or colitis is administered as a single dose or as multiple doses. In certain embodiments, a Consortia is administered once a day for 2 days, 3 days, 4 days, 5 days, 6 days, 125 week, 2 weeks 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, or 1 year. In certain embodiments, a Consortia is administered multiple times daily. In certain embodiments, a Consortia is administered twice daily, three times daily, 4 times daily, or 5 times daily. In certain embodiments, a Consortia is administered intermittently. In certain embodiments, a Consortia is administered once weekly, once monthly, or when a subject is in need thereof. In certain embodiments, the Consortia is KAN-004.In certain embodiments, a Consortia is administered at an effective dose to allow for engraftment and substrate metabolism. In certain embodiments, a Consortia is administered at an effective dose to allow for engraftment and significant SCFA production. In certain embodiments, a Consortia is administered at an effective dose to allow for engraftment and reduced inflammation35 of the gastrointestinal tract.ACTIVE 511662979.2 34PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT In certain embodiments, a Consortia is administered at a first loading dose and then followed by maintenance doses. In certain embodiments, the first loading dose is administered for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days. In certain embodiments, the loading dose is administered for 1-3 days. In certain embodiments, the loading5 dose is administered for 2-4 days. In certain embodiments, the loading dose is administered for 2- 3 days. In certain embodiments, the loading dose is administered for 3-5 days. In certain embodiments, the loading dose is administered for 4-6 days. In certain embodiments, the loading dose is administered for 5-7 days. In certain embodiments, the loading dose is administered for 1 day. In certain embodiments, the loading dose is administered for 3 days. In certain embodiments,10 the loading dose is administered for 2 days.In certain embodiments, the loading dose is administered for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days after the immunotherapy. In certain embodiments, the loading dose is administered for 1-3 days after the immunotherapy. In certain embodiments, the loading dose is administered for 2-4 days after the immunotherapy. In certain embodiments, the loading dose is administered for 2-3 days after the immunotherapy. In certain embodiments, the loading dose is administered for 3-5 days after the immunotherapy. In certain embodiments, the loading dose is administered for 4-6 days after the immunotherapy. In certain embodiments, the loading dose is administered for 5-7 days after the immunotherapy. In certain embodiments, the loading dose is administered for 1 day after the immunotherapy. In certain embodiments, the loading dose is administered for 3 days after the immunotherapy. In certain embodiments, the loading dose is administered for 2 days after the immunotherapy.In certain embodiments, the loading dose is administered 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10, hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, 1 day, 225 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 2 months, 3 months, 4 months, 5 months, 6 months or longer after the onset of one or more phenotypes associated with an immune-related adverse event. In certain embodiments, the loading dose is administered daily for the duration of the immunotherapy administered to the patient.In certain embodiments, the maintenance doses are administered for 5-10 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 7-12 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 10-14 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 14-21 days following the last loading dose. In certain35 embodiments, the maintenance doses are administered for 21-28 days following the last loadingACTIVE 511662979.2 35PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT dose. In certain embodiments, the maintenance doses are administered for 14 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 21 days following the last loading dose. In certain embodiments, the maintenance doses are administered for 28 days following the last loading dose. In certain embodiments, the maintenance doses are5 administered for about 8 days following the last loading dose. In certain embodiments, the maintenance doses are administered for about 7 days following the last loading dose. In certain embodiments, the maintenance doses are administered for about 6 days following the last loading dose. In certain embodiments, the maintenance doses are administered for about 9 days following the last loading dose. In certain embodiments, the maintenance doses are administered for about10 10 days following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 21 days following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 1 month following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 2 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 4 months following the last loading dose. In certain embodiments, the maintenance doses are administered for the maintenance doses are administered for at least 6 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 8 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 10 months following the last loading dose. In certain embodiments, the20 maintenance doses are administered for at least 12 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 18 months following the last loading dose. In certain embodiments, the maintenance doses are administered for at least 24 months following the last loading dose. In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 6 days (for a total of a 8-day course of25 treatment). In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 7 days (for a total of a 9-day course of treatment). In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 8 days (for a total of a 10 day course of treatment). In certain embodiments, the loading dose is administered for 9 days and the maintenance dose is administered for 9 days (for a total of a 11 day course of treatment). In certain embodiments, the loading dose is administered for 2 days and the maintenance dose is administered for 10 days (for a total of a 12 day course of treatment). In certain embodiments, the Consortia is KAN-004. In certain embodiments, the loading dose follows the pretreatment with antibiotics as described in the Combination Therapy section below. In certain embodiments, the loading dose follows the pretreatment with a bowel35 preparation as described in the Combination Therapy section below. In certain embodiments, theACTIVE 511662979.2 36PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENT loading dose follows the pretreatment with antibiotics and a bowel preparation as described in theCombination Therapy section below.In certain embodiments, a Consortia is administered at a loading dose and then followed by maintenance doses. In certain embodiments, the loading dose comprises about 1012viable5 cells. In certain embodiments, the loading dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise about 1011viable cells. In certain embodiments, the loading dose comprises 10 coated enteric capsules. In certain embodiments, the loading dose is administered for 1 day. In certain embodiments, the loading dose is administered twice a day. In certain embodiments, the maintenance dose comprises about10 2 x io11viable cells. In certain embodiments, each maintenance dose comprises one or more coated enteric capsules. In certain embodiments, the one or more coated enteric capsules comprise about 1011viable cells. In certain embodiments, each maintenance dose comprises 2 coated enteric capsules. In certain embodiments, the maintenance doses are administered for 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks,3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 10 weeks, or 12 weeks following the last loading dose.In certain embodiments, KAN-004 is formulated by blending the lyophilized microbial species (e.g., depicted in Figures 5A-5A and 11) and filling them into coated enteric capsules. In certain embodiments, the capsules of KAN-004 are provided in blister packaging or alternative packaging to allow for no or low oxygen exposure (e.g., packaging to sustain the viability of anaerobic microbes). In certain embodiments, each capsule contains a range of 5 * 1010to 5 * 1011viable cells / capsule. In certain embodiments, each capsule contains a range of 5 * 109to 5 * 1010viable cells / capsule. In certain embodiments, each capsule contains a range of 5 * 1011to 5 * 1012viable cells / capsule. In certain embodiments, KAN-004 is orally dosed at up to 1012viable cells25 on Days 1 and 2, and up to 1011viable cells on Days 3 to 10. In certain embodiments, maltodextrin is included as an excipient in the capsules.In certain embodiments, each capsule of KAN-004 contains a range of 5 * 1010to 5 * 1011viable cells / capsule and a viable cell count basis and with relative abundance values of the 145 strains ranging from 18% to 0.015%.In certain embodiments, the methods disclosed herein comprise diagnosing immune- related diarrhea and / or colitis in a subject and then treating the subject with the Consortia or pharmaceutical composition thereof. For example, but not by way of limitation, a method of treating a subject having immune-related diarrhea and / or colitis can include (a) diagnosing the subject with immune-related diarrhea and / or colitis and (b) administering an effective amount of35 a Consortia (e.g., KAN-004) or pharmaceutical composition thereof to the subject.ACTIVE 511662979.2 37PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT In certain embodiments, a Consortia can be administered via an enteric route. For example, in certain non-limiting embodiments, a microbial consortium is administered orally, rectally (e.g., by enema, suppository, or colonoscope), or by oral or nasal tube.In certain embodiments, a Consortia is administered orally. In certain embodiments the5 oral administration is by a powder. In certain embodiments the oral administration is by a slurry. In certain embodiments the oral administration is by pills or capsules.In certain embodiments, a Consortia can be administered to a specific location along the gastrointestinal tract. For example, in certain non-limiting embodiments, a microbial consortium can be administered into one or more gastrointestinal location including the mouth, esophagus,10 stomach, small intestine (duodenum, jejunum, ileum), large intestine (cecum, ascending colon, transverse colon, descending colon), or rectum. In certain embodiments, a microbial consortium can be administered in all regions of the gastrointestinal tract.In certain embodiments, KAN-004 can be administered orally via a pill or capsule.3. ImmunotherapiesIn certain embodiments, the immunotherapy is an immune checkpoint inhibitor (ICI). Exanples of ICIs include, but are not limited to antagonists of the PD-1, PD LI, CTLA-4, BTLA, TIM3, LAG-3, TIGIT, B7-H3, VISTA, or ICOS pathways. In certain embodiments, the ICI comprises an anti-PDl antibody, an anti-PD-Ll antibody, an anti-CTLA-4 antibody, an anti- BTLA antibody, an anti-TIM3 antibody, an anti-LAG-3 antibody, an anti-LAG-3 antibody, an20 anti-TIGIT antibody, an anti-B7-H3 antibody, an anti-VISTA antibody, an anti-ICOS antibody, or a combination thereof. In certain embodiments, the ICI comprises an anti-PDl antibody and an anti-CTLA-4 antibody. In certain embodiments, the ICI is an anti-PDl antibody, such as pembrolizumab, nivolumab, cemiplimab, dostarlimab, retifanlimab-dlwr, or tislelizumab. In certain embodiments, the ICI is an anti-PD-Ll antibody, such as atezolizumab, avelumab, or durvalumab. In certain embodiments, the ICI is an anti-CTL4 antibody, such as ipilimumab or tremelimumab.4. ConsortiaThe present disclosure provides Consortia comprising a plurality of active microbes and an effective amount of a supportive community of microbes.30 In certain embodiments, the Consortia is designated as "FB-003” or “KAN-004.” In certain embodiments, the Consortia KAN-004 is set forth in Table 1. KAN-004 includes DS1, DS2, DS3, and DS4 as set forth in Table 1 and Figures 1 and 2. In certain embodiments, the Consortia comprises the microbiota that are at least 97% or at least 98% identical to those listed in Table 1.ACTIVE 511662979.2 38PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT In certain embodiments, the Consortia comprises a plurality of microbes (e.g., active microbes and supportive community microbes) designated as “FB-003” or “KAN-004.” In certain embodiments, the Consortia comprises a plurality of microbes listed in Table 1. In certain embodiments, the Consortia comprises at least 140 microbes, at least 141 microbes, or at least 1425 microbes of KAN-004. Table 1 is provided below.In certain embodiments, each microbe of KAN-004 comprises a 16s RNA comprising a nucleotide sequence identified in Figures 5A, 5B, and 5C, cumulatively. In certain embodiments, KAN-004 comprises the strains listed in Figures 5A, 5B, and 5C, cumulatively. In certain embodiments, KAN-004 consists of the strains listed in Figures 5A, 5B, and 5C, cumulatively.In certain embodiments, each microbe of KAN-004 comprises each of the species listed, cumulatively, in Figures 5A, 5B, and 5C.In certain embodiments, KAN-004 comprises the species listed in Figure 11. In certain embodiments, KAN-004 consists of the species listed in Figure 11. In certain embodiments, KAN-004 comprises the species associated with the NCBI Tax ID numbers listed in Figure 11. In certain embodiments, KAN-004 consists of the species associated with the NCBI Tax ID numbers listed in Figure 11.In certain embodiments, the Consortia comprises a plurality of microbes comprising strains of the microbes listed in Figure 11. In certain embodiments, the Consortia comprises a plurality of microbes consisting of strains of the microbes listed in Figure 11.20 Additional information on KAN-004 disclosed herein can be found in International Patent Application Nos. PCT / US2022 / 051477 and PCT / US2024 / 019341, the contents of each of which are incorporated by reference in their entireties.Table 1. KAN-004 Drug SubstancesACTIVE 511662979.2 39PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 40PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 41PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 42PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTIn certain embodiments, the Consortia comprises a plurality of microbes (e.g., active microbes and supportive community microbes) designated as “DS1.” In certain embodiments, Consortia DS1 comprises Clostridium cilroniae. Bacteroides salyer siae. Blautia obeum.5 Parabacteroides merdcte. Parabacteroides dislasonis. Anaerostipes hadrus. Lachnospiraceae sp. FBI00033 (also known as Lacrimispora amygdalinaf Eubacterium eligens, Bifidobacterium denlium. Blautia w exlerae. Fusicatenibacter saccharivorans. Bacteroides nordii. Dorea formicigenerans. Dorea longicalena. Bacteroides stercorirosoris (also known as Bacteroides oleiciplenus). Bifidobacterium longum. Bacteroides kribbi (also known as Bacteroides koreensis).10 Lachnospiraceae sp. FBI00071 (also known as Roseburia faecis). Bacteroides thetaiotaomicron,ACTIVE 511662979.2 43PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also known as Clostridium symbiosum), Coprococcus comes, Blautia faecis, Hungatella hathewayi, Bacteroides slercoris, Collinsella aerofctciens, Hungatella effluvia (also known as Hungatella effiuvn), Bifidobacterium adolescentis, Bifidobacterium calenulalum. Lactobacillus rogosae (also5 known as Lachnospira peclinoschiza , Bacteroides faecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as Clostridium prolinivorans), Ruminococcus faecis, Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, Butyricimonas faecihominis, Eisenbergiella tayi,10 Acidaminococcus intestini, Emergencia timonensis, Bifidobacterium pseudocatenulatum, Eubacterium hallii (also known as Anaerobutyricum hallii), Anaerofustis stercorihominis, Eubacterium ventriosum, Blautia hydrogenotrophica, and Lachnospiraceae sp. FBI00290 (also known as Eubacterium ruminantium).In certain embodiments, Consortia DS1 comprises FBI00001, FBI00002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033, FBI00034, FBI00043, FBI00044, FBI00048,FBI00050, FBI00051, FBI00057, FBI00059, FBI00060, FBI00070, FBI00071, FBI00076,FBI00079, FBI00087, FBI00093, FBI00102, FBI00109, FBI00117, FBI00120, FBI00125,FBI00127, FBI00128, FBI00145, FBI00162, FBI00174, FBI00184, FBI00190, FBI00191,FBI00194, FBI00198, FBI00199, FBI00200, FBI00201, FBI00205, FBI00206, FBI00211,FBI00220, FBI00221, FBI00236, FBI00245, FBI00248, FBI00251, FBI00254, FBI00267,FBI00278, FBI00288, and FBI00290.In certain embodiments, each microbe of Consortia DS1 comprises a 16s RNA comprising a nucleotide sequence identified in Figures 5A, 5B, and 5C, cumulatively. In certain embodiments, each microbe of Consortia DS1 consists of a 16s RNA comprising a nucleotide25 sequence identified in Figures 5A, 5B, and 5C, cumulatively.Additional information on the Consortia DS1 disclosed herein can be found inInternational Patent Application Nos. PCT / US2022 / 051477 and PCT / US2024 / 019341, the contents of each of which is incorporated by reference in their entireties.In certain embodiments, the Consortia comprises a plurality of microbes (e.g., active microbes and supportive community microbes) designated as “DS2.” In certain embodiments, Consortia DS2 comprises Acutalibacter timonensis (also known as Neglecta timonensis), Alistipes onderdonkii, Bacteroides uniformis, Eubacterium rectale (also known as Agathobacter rectalis), Alistipes timonensis, Bacteroides kribbi, Coprococcus eutactus, Bilophila wadsworthia, Bacteroides caccae, Alistipes shahii, Parasutterella excrementihominis, Paraprevotella clara,35 Sutterella wadsworthensis, Sutterella massiliensis, Porphyromonas asaccharolytica,ACTIVE 511662979.2 44PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Ruminococcus bromii. Monoglobus peclinilylicus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter pamelaeae, Bacteroides uniformis, Gordonibacter pamelaeae, Bacteroides fragilis, Phascolarctobacterium faecium, Monoglobus pectinilyticus, Clostridium aldenense, Ruthenibacterium lac tatif ormans, Bacteroides ovatus (also known as5 Bacteroides koreensis), Bifidobacterium bifidum, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutterella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis), Alistipes senegalensis, Ruminococcaceae sp. FBI00233 (also known as Anaerotruncus colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum, Faecalibacterium prausnitzii, Turicibacter sanguinis,10 Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, and Methanobrevibacter smithii.In certain embodiments, Consortia DS2 comprises FBI00004, FBI00012, FBI00015, FBI00018, FBI00019, FBI00021, FBI00038, FBI00040, FBI00046, FBI00061, FBI00066, FBI00075, FBI00077, FBI00080, FBI00081, FBI00085, FBI00092, FBI00097, FBI00099,FBI00112, FBI00132, FBI00137, FBI00140, FBI00149, FBI00151, FBI00176, FBI00189,FBI00197, FBI00208, FBI00212, FBI00224, FBI00226, FBI00229, FBI00233, FBI00235,FBI00237, FBI00243, FBI00244, FBI00258, FBI00260, FBI00263, FBI00270, FBI00273,FBI00277, and FBI00292.20 In certain embodiments, each microbe of Consortia DS2 comprises a 16s RNA comprising a nucleotide sequence identified in Figures 5A, 5B, and 5C, cumulatively. In certain embodiments, each microbe of Consortia DS2 consists of a 16s RNA comprising a nucleotide sequence identified in Figures 5A, 5B, and 5C, cumulatively.Additional information on the Consortia DS2 disclosed herein can be found in25 International Patent Application Nos. PCT / US2022 / 051477 and PCT / US2024 / 019341, the contents of each of which is incorporated by reference in their entireties.In certain embodiments, the Consortia comprises a plurality of microbes (e.g., active microbes and supportive community microbes) designated as “DS3.” In certain embodiments, Consortia DS3 comprises Bifidobacterium adolescentis (also known as Bifidobacterium faecale . Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes, Fusicatenibacter saccharivorans, Eggerthella lenla, Eubacterium eligens, Bacteroides xylanisolvens, Lactobacillus rogosae (also known as Lachnospira peclinoschiza , Clostridium cilroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenla, Blautia wexlerae (also known as Blautia lull), Lachnoclostridium pacaense, Bacteroides vulgalus,35 Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis.ACTIVE 511662979.2 45PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Anaerostipes hadrus. Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolleae. Eisenbergiella tayi, Dorea longicatena, Eggerthella lenla. Bacteroides slercoris. Hungatella hathewayi, and Bacteroides xylanisolvens.In certain embodiments, Consortia DS3 comprises FBI00009, FBI00011, FBI00016,5 FBI00020, FBI00025, FBI00027, FBI00030, FBI00047, FBI00052, FBI00053, FBI00056,FBI00062, FBI00078, FBI00096, FBI00104, FBI00110, FBI00111, FBI00113, FBI00115,FBI00116, FBI00123, FBI00124, FBI00126, FBI00135, FBI00147, FBI00159, FBI00167,FBI00170, FBI00232, FBI00255, and FBI00271.In certain embodiments, each microbe of Consortia DS3 comprises a 16s RNA comprising10 a nucleotide sequence identified in Figures 5A, 5B, and 5C. In certain embodiments, each microbe of Consortia DS3 comprises a 16s RNA consists of a nucleotide sequence identified in Figures 5A, 5B, and 5C.Additional information on the Consortia DS3 disclosed herein can be found in International Patent Application Nos. PCT / US2022 / 051477 and PCT / US2024 / 019341, the contents of each of which is incorporated by reference in their entireties.In certain embodiments, the Consortia comprises a plurality of microbes (e.g., active microbes and supportive community microbes) designated as “DS4.” In certain embodiments, Consortia DS4 comprises Alistipes pulredinis. Dialister succinaliphilus. Akkermansia muciniphila. Ruminococcus bromii. Dialister invisus. Bacteroides massiliensis. Bilophila wadsworthia, Holdemanella biformis. Parasutterella excremenlihominis. Alistipes sp. FBI00180 (also known as Alistipes senegalensis . Bacteroides coprocola. Alistipes sp. FBI00238 (also known as Alistipes finegoldii . Alistipes pulredinis. Eubacterium xylanophilum. and Senegalimassilia anaerobia.In certain embodiments, Consortia DS4 comprises FBI00022, FBI00049, FBI00068,25 FBI00069, FBI00152, FBI00165, FBI00171, FBI00175, FBI00177, FBI00180, FBI00182, FBI00238, FBI00269, FBI00274, and FBI00281.In certain embodiments, each microbe of Consortia DS4 comprises a 16s RNA comprising a nucleotide sequence identified in Figures 5A, 5B, and 5C. In certain embodiments, each microbe of Consortia DS4 comprises a 16s RNA consists of a nucleotide sequence identified in Figures 5A, 5B, and 5C.Additional information on the Consortia DS4 disclosed herein can be found in International Patent Application Nos. PCT / US2022 / 051477 and PCT / US2024 / 019341, the contents of each of which is incorporated by reference in their entireties.In certain embodiments, the Consortia comprises a plurality of microbes (e.g., active35 microbes and supportive community microbes) comprising strains of the microbes depicted inACTIVE 511662979.2 46PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Figure 11. In certain embodiments, the Consortia comprises a plurality of microbes (e.g., active microbes and supportive community microbes) consisting of strains of the microbes depicted in Figure 11. In certain embodiments, the Consortia comprises or consists of strains of Bifidobacterium adolescentis, Bifidobacterium bifidum. Bifidobacterium calenulalum.5 Bifidobacterium denlium. Bifidobacterium faecale. Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Collinsella aerofaciens. Eggerthella lenla. Gordonibacter pamelaeae, Senegalimassilia anaerobia. Alistipes finegoldii. Alistipes onderdonkii. Alistipes pulredinis. Alistipes senegalensis. Alistipes shahii. Alistipes timonensis, Bacteroides caccae, Bacteroides coprocola, Bacteroides faecis, Bacteroides finegoldii, Bacteroides fragilis, Bacteroides koreensis,10 Bacteroides kribbi, Bacteroides massiliensis, Bacteroides nordii, Bacteroides oleiciplenus, Bacteroides salyer siae, Bacteroides slercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides xylanisolvens, Barnesiella inleslinihominis, Butyricimonas faecihominis, Parabacteroides dislasonis, Parabacteroides merdae, Paraprevotella clara, Phocaeicola vulgatus, Porphyromonas asaccharolylica, Methanobrevibacter smilhii, Acidaminococcus inleslini, Agathobacter reclalis, Anaerobutyricum hallii, Anaerofustis slercorihominis, Anaerostipes hadrus, Anaerotruncus colihominis, Blautia faecis, Blautia hydrogenotrophica, Blautia hili, Blautia obeum, Blautia w exlerae, Christensenella hongkongensis, Clostridium aldenense, Clostridium bolleae, Clostridium cilroniae, Clostridium closlridioforme, Clostridium prolinivorans, Clostridium scindens, Clostridium symbiosum, Coprococcus comes, Coprococcus20 eutactus, Dialister invisus, Dialister succinatiphilus, Dielma fastidiosa, Dorea formicigenerans, Dorea longicatena, Eisenbergiella tayi, Emergencia timonensis, Eubacterium eligens, Eubacterium ruminantium, Eubacterium siraeum, Eubacterium ventriosum, Eubacterium xylanophilum, Faecalibacterium prausnitzii, Fusicatenibacter saccharivorans, Holdemanella biformis, Hungatella effluvii, Hungatella hathewayi, Lachnoclostridium pacaense, Lachnospira pectinoschiza, Lacrimispora amygdalina, Longicatena caecimuris, Megasphaera massiliensis, Merdimmobilis hominis, Monoglobus pectinilyticus, Neglecta timonensis, Phascolarctobacterium faecium, Roseburia faecis, Roseburia hominis, Ruminococcus bromii, Ruminococcus faecis, Ruthenibacterium lactatif ormans, Turicibacter sanguinis, Parasutterella excrementihominis, Sutterella massiliensis, Sutterella wadsworthensis, Bilophila wadsworthia, and Akkermansia30 muciniphila n certain embodiments, each microbe of the Consortia comprises a 16s RNA comprising a nucleotide sequence associated with the NCBI Tax ID numbers listed in Figure 11. In certain embodiments, each microbe of the Consortia consists of a 16s RNA comprising a nucleotide sequence associated with the NCBI Tax ID numbers listed in Figure 11.ACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Additional Consortia encompassed by the present disclosure can be found in International Patent Application Nos. PCT / US2022 / 051477 and PCT / US2024 / 019341, the contents of each of which is incorporated by reference in their entireties.In certain embodiments, a microbial consortium or Consortia comprises a microbial strain5 having a relative abundance of approximately 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.1%, 0.01%, 0.001%, 0.0001%, 0.00001%, or 0.000001% of the total microbial consortium. In certain embodiments, the relative abundance of a microbial strain is determined by metagenomic sequencing and calculated as the percentage of reads that are classified as an identified microbial strain, divided by the genome size. In certain embodiments, the relative10 abundance of a microbial strain of the present disclosure is determined by metagenomic shotgun sequencing.5. Active and Supportive Community of MicrobesThe Consortia described herein comprise a plurality of active microbes.Furthermore, the Consortia of the present disclosure further comprise a supportive community of microbes that enhances one or more characteristics of the plurality of active microbes. For example, in certain non-limiting embodiments, the supportive community of microbes enhances gastrointestinal engraftment of the plurality of active microbes. In other embodiments, the supportive community of microbes enhances biomass of the plurality of active microbes. In other embodiments, the supportive community of microbes enhances metabolism of20 the first metabolic substrate by the plurality of active microbes. In other embodiments, the supportive community of microbes enhances longitudinal stability of the plurality of active microbes.The supportive community of microbes disclosed herein metabolize one or more metabolite produced by the plurality of active microbes, wherein the one or more metabolites inhibits metabolism of the plurality of active microbes. In certain embodiments, the supportive community of microbes of the current disclosure catalyzes the fermentation of polysaccharides to one or more of the group consisting of acetate, acetoin, 2-oxoglutarate, propionate, 1,3- propanediol, succinate, ethanol, lactate, butyrate, 2,3-butanediol, acetone, butanol, formate, EE, and CO2. In certain embodiments, the supportive community of microbes catalyzes the30 fermentation of amino acids to one or more of the group consisting of acetate, propionate, butanoate, butyrate, isobutyrate, 2-methylbutyrate, isovalerate, isocaproate, 3-phenylpropanoate, phloretate, 3-(lH-indol-3-yl)propanoate, 5-aminopentanoate, EE, EES, and CO2. In certain embodiments, the supportive community catalyzes the synthesis of one or more of the group consisting of methane from EE and CO2, methane from formate and EE, acetate from EE and CO2,ACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT acetate from formate and EE, acetate and sulfide from EE, CO2, and sulfate, propionate and CO2 from succinate, succinate from H2 and fumarate; synthesis of succinate from formate and fumarate, and butyrate, acetate, H2, and CO2 from lactate. In certain embodiments, the supportive community of microbes of the current disclosure catalyzes the deconjugation of conjugated bile5 acids to produce primary bile acids, the conversion of cholic acid (CA) to 7-oxocholic acid, the conversion of 7-oxocholic acid to 7-beta-cholic acid (7betaCA), the conversion of chenodeoxycholic acid (CDCA) to 7-oxochenodeoxycholic acid, and / or the conversion of 7- oxochenodeoxycholic acid to ursodeoxycholic acid (UDCA).6. Consortia Design10 In certain embodiments, microbial consortia disclosed herein are designed to meet one or more of the following criteria:(i) an ability to eliminate or reduce levels of a first metabolic substrate causing or contributing to a disease in an animal;(ii) an ability to metabolize or convert one or more metabolite produced by the metabolism of the first metabolic substrate;(iii) an ability to metabolize one or more nutrient typically found in the human diet;(iv) an ability to fulfill unique and potentially beneficial biological functions in the gastrointestinal (GI) tract (e.g., bile salt hydrolase activity or butyrate production);(v) an ability to engraft in various biological niches and physical and metabolic20 compartments of the GI tract of an animal;(vi) an ability to increase biomass upon engraftment in the GI tract;(vii) an ability to have longitudinal stability in the GI tract of an animal;(viii) an ability to increase the flux of a precursor of the first metabolic substrate into a biochemical pathway that converts said precursor into a metabolite that is not the first metabolic substrate;(ix) diversity of component microbial species across one or more taxonomic phyla; and(x) natural prevalence of component microbial species in the GI tract of healthy adults. In certain embodiments, the microbial consortia of the present disclosure are designed to comprise a plurality of active microbes capable of metabolizing a first metabolic substrate that30 causes or contributes to disease in an animal. In certain embodiments, the first metabolic substrate may be selected from, but not limited to, oxalate and a bile acid (e.g., lithocholic acid (LCA), deoxycholic acid (DCA)). In certain embodiments, the microbial consortium is designed to be capable of metabolizing the first metabolic substrate across a variety of pH ranges found within the GI tract (e.g., pH 4 to 8). In certain embodiments, the microbial consortium is designed to beACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT capable of metabolizing the first metabolic substrate in the presence of various concentrations of first metabolic substrate as they exist in different regions of the GI tract.In certain embodiments, the Consortia is KAN-004 (e.g., disclosed in Table 1, Figures 5A- 5C, and Figure 11) or a functional equivalent thereof. In certain embodiments, KAN-004 is 5 defined by its function. In certain embodiments, KAN-004 is defined by its function as set forth in Tables 2 or 3. In certain embodiments, KAN-004 is defined by its function as set forth in Tables 2 and 3.Table 2. Function Properties of KAN-004 DPs10Table 3. Species Included in KAN-004 Drug Products and CharacteristicsACTIVE 511662979.2 50PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 51PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 52PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTIn certain embodiments, KAN-004 is defined by its function as set forth in Tables 4-6. In certain embodiments, KAN-004 is defined by its function as set forth in one or more of Tables 4- 6. In certain embodiments, KAN-004 is defined by its function as set forth in Tables 2-6. In5 certain embodiments, KAN-004 is defined by its function as set forth in one or more of Tables 2- 6.Table 4. Characterization of strain-level macronutrient utilization by Biolog assay in 98 strains with positive growth signatures.ACTIVE 511662979.2 53PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 54PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 55PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 56PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 57PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 58PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 59PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 60PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 61PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTACTIVE 511662979.2 62PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTTable 5. Characterization of the 41 strains that did not show positive growth signatures by Biolog assayACTIVE 511662979.2 63PCT / US25 / 41609 12 August 2025 (12.08.2025)Table 6. Seven-day growth scores for strains FBI00176 Ruthenibacterium lactatiformans andFBI00273 Barnesiella intestinihominis5 In certain embodiments, the Consortia is KAN-004 or a functional equivalent thereof. In certain embodiments, the Consortia is DS1 or a functional equivalent thereof. In certainACTIVE 511662979.2 64PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT embodiments, the Consortia is DS2 or a functional equivalent thereof. In certain embodiments, the Consortia is DS3 or a functional equivalent thereof. In certain embodiments, the Consortia is DS4 or a functional equivalent thereof. In certain embodiments, Consortia can be defined by its function. In certain embodiments, Consortia can be defined by its function as set forth in Tables5 2-6. In certain embodiments, Consortia can be defined by its function as set forth in one or more of Tables 2-6.7. Methods of PreparationThe present disclosure also provides methods for preparing and / or manufacturing the microbial consortia described herein.10 In certain embodiments, the methods comprise obtaining a donor stool and preparing a stool dilution. In certain embodiments, the stool dilution is plated onto an agar plate. In certain embodiments, the agar plate includes an anaerobic media. In certain embodiments, the agar plate includes colonies. Characterization and quality analysis of these colonies can be performed. For example, but without any limitation, 16s RNA and / or MALDI mass spectrometry could be performed. In certain embodiments, the characterized colonies can be further expanded in a broth culture. After growth and expansion, the microbes can be stored in vials for further use.In certain embodiments, the microbes can be further expanded in a bioreactor including a cell culture medium. In certain embodiments, the cell culture medium can include: a) soytone, D-cellobiose, yeast extract, dextrose (glucose), maltose monohydrate,20 magnesium sulfate heptahydrate, calcium chloride dihydrate, potassium phosphate monobasic, potassium phosphate dibasic, sodium chloride, sodium bicarbonate, volatile fatty acid solution, L- cysteine HC1 monohydrate, hemin solution, vitamin solution, or a combination thereof; or b) soytone, D-cellobiose, yeast extract, dextrose (glucose), maltose monohydrate, magnesium sulfate heptahydrate, calcium chloride dihydrate, potassium phosphate monobasic, potassium phosphate dibasic, sodium chloride, ammonium sulfate, sodium bicarbonate, volatile fatty acid solution, L-cysteine HC1 monohydrate, hemin solution, vitamin solution, or a combination thereof.In certain embodiments, the cell culture medium is YCFAC. In certain embodiments, the cell culture medium further comprises threonine.30 In certain embodiments, the microbes can be expanded in a bioreactor in anaerobic conditions. In certain embodiments, the microbes can be expanded in a bioreactor in the presence of gas overlay. In certain embodiments, the microbes can be expanded in a bioreactor in absence of gas sparing.In certain embodiments, the methods include expanding microbes in mixed cultures.ACTIVE 511662979.2 65PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTIn certain embodiments, the methods comprise expanding microbes in a first mixed culture or composition comprising: a) Clostridium citroniae, Bacteroides salyersiae, Blautia obeum, Parabacteroides merdae, Parabacteroides distasonis, Anaerostipes hadrus, Lachnospiraceae sp. FBI00033 (also known as5 Lacrimispora amygdalina), Eubacterium eligens, Bifidobacterium dentium, Blautia wexlerae,Fusicatenibacter saccharivorans, Bacteroides nordii, Dorea formicigenerans, Dorea longicatena, Bacteroides stercorirosoris (also known as Bacteroides oleiciplenus), Bifidobacterium longum, Bacteroides kribbi (also known as Bacteroides koreensis), Lachnospiraceae sp. FBI00071 (also known as Roseburia faecis), Bacteroides thetaiotaomicron,10 Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also known as Clostridium symbiosum), Coprococcus comes, Blautia faecis, Hungatella hathewayi, Bacteroides stercoris, Collinsella aerofaciens, Hungatella effluvii, Bifidobacterium adolescentis, Bifidobacterium catenulatum, Lactobacillus rogosae (also known as Lachnospira pectinoschiza),Bacteroides faecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as Clostridium prolinivorans), Ruminococcus faecis, Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, Butyricimonas faecihominis, Eisenbergiella tayi, Acidaminococcus intestini, Emergencia timonensis,Bifidobacterium pseudocatenulatum, Eubacterium hallii (also known as Anaerobutyricum hallii),Anaerofustis stercorihominis, Eubacterium ventriosum, Blautia hydrogenotrophica, andLachnospiraceae sp. FBI00290 (also known as Eubacterium ruminantium), or a functional equivalent thereof; or b) FBI00001, FBI00002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033,FBI00034, FBI00043, FBI00044, FBI00048, FBI00050, FBI00051, FBI00057, FBI00059,25 FBI00060, FBI00070, FBI00071, FBI00076, FBI00079, FBI00087, FBI00093, FBI00102,FBI00109, FBI00117, FBI00120, FBI00125, FBI00127, FBI00128, FBI00145, FBI00162,FBI00174, FBI00184, FBI00190, FBI00191, FBI00194, FBI00198, FBI00199, FBI00200,FBI00201, FBI00205, FBI00206, FBI00211, FBI00220, FBI00221, FBI00236, FBI00245,FBI00248, FBI00251, FBI00254, FBI00267, FBI00278, FBI00288, andFBI00290, or a functional equivalent thereof.In certain embodiments, the methods comprise expanding microbes in a second mixed culture or composition comprising: a) Acutalibacter timonensis (also known as Neglecta timonensis), Alistipes onderdonkii, Bacteroides uniformis, Eubacterium rectale (also known as Agathobacter rectalis), Alistipes35 timonensis, Bacteroides kribbi, Coprococcus eutactus, Bilophila wadsworthia, BacteroidesACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENT caccae, Alistipes shahii, Parasutterella excrementihominis, Paraprevotella clara, Sutterella wadsworthensis, Sutterella massiliensis, Porphyromonas asaccharolytica, Ruminococcus bromii, Monoglobus pectinilyticus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter pamelaeae, Bacteroides uniformis, Gordonibacter pamelaeae,5 Bacteroides fragilis, Phascolarctobacterium faecium, Monoglobus pectinilyticus, Clostridium aldenense, Ruthenibacterium lactatiformans, Bacteroides ovatus (also known as Bacteroides koreensis), Bifidobacterium bifidum, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutterella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis), Alistipes senegalensis, Ruminococcaceae sp.10 FBI00233 (also known as Anaerotruncus colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum, Faecalibacterium prausnitzii, Turicibacter sanguinis, Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, and Methanobrevibacter smithii, or a functional equivalent thereof; or b) FBI00004, FBI00012, FBI00015, FBI00018, FBI00019, FBI00021, FBI00038, FBI00040, FBI00046, FBI00061, FBI00066, FBI00075, FBI00077, FBI00080, FBI00081, FBI00085, FBI00092, FBI00097, FBI00099, FBI00112, FBI00132, FBI00137, FBI00140, FBI00149, FBI00151, FBI00176, FBI00189, FBI00197, FBI00208, FBI00212, FBI00224, FBI00226, FBI00229, FBI00233, FBI00235, FBI00237, FBI00243, FBI00244, FBI00258,20 FBI00260, FBI00263, FBI00270, FBI00273, FBI00277, and FBI00292, or a functional equivalent thereof.In certain embodiments, the methods comprise expanding microbes in a third mixed culture or composition comprising: a) Bifidobacterium adolescentis (also known as Bifidobacterium faecale), Bifidobacterium25 longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes, Fusicatenibacter saccharivorans, Eggerthella lenta, Eubacterium eligens, Bacteroides xylanisolvens, Lactobacillus rogosae (also known as Lachnospira peclinoschiza , Clostridium citroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenta, Blautia wexlerae (also known as Blautia luti), Lachnoclostridium pacaense, Bacteroides vulgatus, Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis, Anaerostipes hadrus, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolteae, Eisenbergiella tayi, Dorea longicatena, Eggerthella lenta, Bacteroides stercoris, Hungatella hathewayi, and Bacteroides xylanisolvens, or a functional equivalent thereof; or b) FBI00009, FBI00011, FBI00016, FBI00020, FBI00025, FBI00027, FBI00030,35 FBI00047, FBI00052, FBI00053, FBI00056, FBI00062, FBI00078, FBI00096, FBI00104,ACTIVE 511662979.2 67PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT FBI00110, FBI00111, FBI00113, FBI00115, FBI00116, FBI00123, FBI00124, FBI00126, FBI00135, FBI00147, FBI00159, FBI00167, FBI00170, FBI00232, FBI00255, and FBI00271, or a functional equivalent thereof.In certain embodiments, the methods comprise expanding microbes in a fourth mixed5 culture or composition comprising: a) Alistipes putredinis, Dialister succinatiphilus, Akkermansia muciniphila, Ruminococcus bromii, Dialister invisus, Bacteroides massiliensis, Bilophila wadsworthia, Holdemanella biformis, Parasutterella excrementihominis, Alistipes sp. FBI00180 (also known as Alistipes senegalensis), Bacteroides coprocola, Alistipes sp. FBI00238 (also known as Alistipes fmegoldii),10 Alistipes putredinis, Eubacterium xylanophilum, and Senegalimassilia anaerobia, or a functional equivalent thereof or b) FBI00022, FBI00049, FBI00068, FBI00069, FBI00152, FBI00165, FBI00171, FBI00175, FBI00177, FBI00180, FBI00182, FBI00238, FBI00269, FBI00274, and FBI00281, or a functional equivalent thereof.In certain embodiments, the methods comprise lyophilizing cultures and compositions described herein. In certain embodiments, the cultures and compositions comprise a lyoprotectant. In certain embodiments, the lyoprotectant comprises maltodextrin. In certain embodiments, the lyoprotectant comprises inulin. In certain embodiments, the lyoprotectant comprises maltodextrin and inulin. In certain embodiments, the maltodextrin is present at a20 concentration of about 8%. In certain embodiments, the inulin is present at a concentration of about 0.5%.In certain embodiments, the methods comprise blending and / or mixing lyophilized cultures and compositions outlined above. Additional information on the strains for each composition can be found in Table 1.In certain embodiments, DS1, DS2, DS3, and DS4 as described in Table 1 are prepared using the methods described in Figures 17, 18, and 19 of International Patent Publication No. WO 2023 / 102091, the content of which is incorporated by reference in its entirety.In certain embodiments, the Consortia described in Figure 11 are prepared using the methods described in International Patent Publication No. WO 2023 / 102091, the content of which30 is incorporated by reference in its entirety. Additional information on the methods of preparation of the consortia disclosed herein can be found in International Patent Application Nos. PCT / US2022 / 051477 and PCT / US2024 / 019341, the contents of each of which is incorporated by reference in their entireties.ACTIVE 511662979.2 68PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENT8. Pharmaceutical CompositionsThe present disclosure also provides pharmaceutical compositions that contain an effective amount of a microbial consortium described herein. The composition can be formulated for use in a variety of delivery systems. One or more physiologically acceptable buffer(s) or carrier(s) can5 also be included in the composition for proper formulation. Suitable formulations for use in the present disclosure are found in Remington's Pharmaceutical Sciences, Mack Publishing Company, Philadelphia, Pa., 17th ed., 1985. For a brief review of methods for drug delivery, see, e.g., Langer (Science 249: 1527-1533, 1990).In certain embodiments, the presently disclosed pharmaceutical composition comprises10 KAN-004. In certain embodiments, the presently disclosed pharmaceutical composition comprises DSL In certain embodiments, the presently disclosed pharmaceutical composition comprises DS2. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS3. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS4. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS1 and DS2. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS1 and DS3. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS1 and DS4. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS2 and DS3. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS2 and DS4. In certain20 embodiments, the presently disclosed pharmaceutical composition comprises DS3 and DS4. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS1, DS2, and DS3. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS1, DS2, and DS4. In certain embodiments, the presently disclosed pharmaceutical composition comprises DS2, DS3, and DS4.In certain embodiments, the presently disclosed pharmaceutical composition comprises the plurality of microbes depicted in Table 1. In certain embodiments, the presently disclosed pharmaceutical composition comprises the plurality of microbes depicted in Figures 5A-5C. In certain embodiments, the presently disclosed pharmaceutical composition comprises the plurality of microbes depicted in Figure 11.30 In certain embodiments, the presently disclosed pharmaceutical composition comprises the plurality of the microbial strains depicted in Figures 5A-5C, cumulatively. In certain embodiments, the presently disclosed pharmaceutical composition comprises the plurality of microbial species depicted in Figure 11. In certain embodiments, the presently disclosed pharmaceutical composition consists of the plurality of the microbial strains depicted in FiguresACTIVE 511662979.2 69PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT 5A-5C, cumulatively. In certain embodiments, the presently disclosed pharmaceutical composition consists of the plurality of microbial species depicted in Figure 11.In certain embodiments, the presently disclosed pharmaceutical composition comprises an amount of at least about 1, at least about 10, at least about 102, at least about 103, at least about5 104, at least about 105, at least about 106, at least about 107, at least about 108, at least about 109, at least about IO10, at least about 1011, at least about 1012, or at least about 1013microbes of each strain (e.g., each strain of KAN-004). In certain embodiments, the presently disclosed pharmaceutical composition comprises between about 1 and about 1013, between about 10 and about 1013, between about 102and about 1013, between about 103and about 1013, between about10 104and about 1013, between about 105and about 1013, between about 106and about 1013, between about 107and about 1013, between about 108and about 1013, between about 109and about 1013, between about IO10and about 1013, between about 1011and about 1013, between about 1012and about 1013, between about 10 and about 1012, between about 10 and about 1011, between about 10 and about IO10, between about 10 and about 109, between about 10 and about 108, between about 10 and about 107, between about 10 and about 106, between about 10 and about 105, between about 10 and about 104, between about 10 and about 103, between about 102and about 1012, between about 102and about 1011, between about 102and about 1010, between about 102and about 109, between about 102and about 108, between about 102and about 107, between about 102and about 106, between about 102and about 105, between about 102and about 104, between about 102and about 103, between about 102and about 109, between about 103and about 109, between about 104and about 109, between about 105and about 109, between about 106and about 109, between about 107and about 109, between about 108and about 109, between about 102and about 106, between about 103and about 106, between about 104and about 106, or between about 105and about 106microbes for each strain (e.g., each strain of KAN-004). In certain embodiments, each strain can25 be present in different amounts. For example, but without any limitation, a pharmaceutical composition comprising a first strain, a second strain, and a third strain can comprise 10 microbes of the first strain, 107microbes of the second strain, 103microbes of the third strain.In certain embodiments, the presently disclosed pharmaceutical composition comprises an amount of at least about 10, at least about 102, at least about 103, at least about 104, at least about105, at least about 106, at least about 107, at least about 108, at least about 109, at least about IO10, at least about 1011, at least about 1012, or at least about 1013CFUs of each strain (e.g., each strain of KAN-004). In certain embodiments, the presently disclosed pharmaceutical composition comprises between about 1 and about 1013, about 10 and about 1013, between about 102and about 1013, between about 103and about 1013, between about 104and about 1013, between about 105and35 about 1013, between about 106and about 1013, between about 107and about 1013, between aboutACTIVE 511662979.2 70PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT 108and about 1013, between about 109and about 1013, between about IO10and about 1013, between about 1011and about 1013, between about 1012and about 1013, between about 102and about 1012, between about 102and about 1011, between about 102and about IO10, between about 102and about 109, between about 102and about 108, between about 102and about 107, between about 102and5 about 106, between about 102and about 105, between about 102and about 104, between about 102and about 103, between about 102and about 109, between about 103and about 109, between about 104and about 109, between about 105and about 109, between about 106and about 109, between about 107and about 109, between about 108and about 109, between about 102and about 106, between about 103and about 106, between about 104and about 106, or between about 105and10 about 106CFUs for each strain (e.g., each strain of KAN-004). In certain embodiments, each strain can be present in different amounts. For example, but without any limitation, a pharmaceutical composition comprising a first strain, a second strain, and a third strain can comprise 10 CFUs of the first strain, 107CFUs of the second strain, 103CFUs of the third strain.In certain embodiments, the presently disclosed pharmaceutical composition comprises an amount of at least about 10’1, at least about 10'2, at least about 10'3, at least about 10'4, at least about 10'5, at least about 10'6, at least about 10'7, at least about 10'8, at least about 10'9, at least about IO'10, at least about 10’11, or at least about 10'12, or at least about 1013grams of each strain (e.g., each strain of KAN-004). In certain embodiments, each strain can be present in different amounts. For example, but without any limitation, a pharmaceutical composition comprising a first strain, a second strain, and a third strain can comprise 10'4grams of the first strain, 10'3grams of the second strain, 1 O'6grams of the third strain.In certain embodiments, the presently disclosed pharmaceutical composition comprises a total amount of at least about 1, at least about 10, at least about 102, at least about 103, at least about 104, at least about 105, at least about 106, at least about 107, at least about 108, at least about25 109, at least about IO10, at least about 1011, at least about 1012, or at least about 1013microbes (e.g., total amount of microbes of KAN-004). In certain embodiments, the presently disclosed pharmaceutical composition comprises a total amount of between about 10 and about 1013, between about 102and about 1013, between about 103and about 1013, between about 104and about 1013, between about 105and about 1013, between about 106and about 1013, between about 107and about 1013, between about 108and about 1013, between about 109and about 1013, between about IO10and about 1013, between about 1011and about 1013, between about 1012and about 1013, between about 102and about 1012, between about 102and about 1011, between about 102and about IO10, between about 102and about 109, between about 102and about 108, between about 102and about 107, between about 102and about 106, between about 102and about 105, between about 10235 and about 104, between about 102and about 103, between about 102and about 109, between aboutACTIVE 511662979.2 71PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT 103and about 109, between about 104and about 109, between about 105and about 109, between about 106and about 109, between about 107and about 109, between about 108and about 109, between about 102and about 106, between about 103and about 106, between about 104and about 106, or between about 105and about 106microbes.5 In certain embodiments, the presently disclosed pharmaceutical composition comprises a total amount of at least about 1, at least about 10, at least about 102, at least about 103, at least about 104, at least about 105, at least about 106, at least about 107, at least about 108, at least about 109, at least about IO10, at least about 1011, at least about 1012, or at least about 1013CFUs (e.g., total CFUs of KAN-004). In certain embodiments, the presently disclosed pharmaceutical10 composition comprises a total amount of between about 10 and about 1013, between about 102and about 1013, between about 103and about 1013, between about 104and about 1013, between about 105and about 1013, between about 106and about 1013, between about 107and about 1013, between about 108and about 1013, between about 109and about 1013, between about IO10and about 1013, between about 1011and about 1013, between about 1012and about 1013, between about 102and about 1012, between about 102and about 1011, between about 102and about IO10, between about 102and about 109, between about 102and about 108, between about 102and about 107, between about 102and about 106, between about 102and about 105, between about 102and about 104, between about 102and about 103, between about 102and about 109, between about 103and about 109, between about 104and about 109, between about 105and about 109, between about 106and about 109, between about 107and about 109, between about 108and about 109, between about 102and about 106, between about 103and about 106, between about 104and about 106, or between about 105and about 106CFUs. In certain embodiments, the presently disclosed pharmaceutical composition comprises between about 105and about 1013, between about 106and about 1013, between about 107and about 1013, between about 108and about 1013, between about 109and about25 1013, between about IO10and about 1013, between about 1011and about 1013, between about 1012and about 1013, between about 105and about 1012, between about 106and about 1012, between about 107and about 1012, between about 108and about 1012, between about 109and about 1012, between about IO10and about 1012, between about 1011and about 1012, between about 105and about 1011, between about 106and about 1011, between about 107and about 1011, between about 108and about 1011, between about 109and about 1011, between about IO10and about 1011, between about 105and about IO10, between about 106and about IO10, between about 107and about IO10, between about 108and about IO10, between about 109and about IO10, between about 105and about 109, between about 106and about 109, between about 107and about 109, between about 108and about 109, between about 5 * 109and about 5 x io10, between about 5 x io9and about 5 x 1011,35 between about 5 x 1Q9and about 5 x 1Q12, between about 5 x 1Q10and about 5 x 1Q12, betweenACTIVE 511662979.2 72PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT about 5 x io11and about 5 x 1012, or between about 5 x io10and about 5 x io11viable cells. In certain embodiments, the presently disclosed pharmaceutical composition comprises between about 5 x io9and about 5 x io12viable cells. In certain embodiments, the presently disclosed pharmaceutical composition comprises between about 5 x io9and about 5 x io10viable cells. In5 certain embodiments, the presently disclosed pharmaceutical composition comprises between about 5 x io10and about 5 x io11viable cells. In certain embodiments, the presently disclosed pharmaceutical composition comprises between about 5 x io11and about 5 x io12viable cells.In certain embodiments, the presently disclosed pharmaceutical composition comprises up to about 105, up to about 106, up to about 107, up to about 108, up to about 109, up to about 1010,10 up to about 1011, up to about 1012, or up to about 1013viable cells. In certain embodiments, the presently disclosed pharmaceutical composition comprises up to about 1011viable cells. In certain embodiments, the presently disclosed pharmaceutical composition comprises up to about 1012viable cells.In certain embodiments, the presently disclosed pharmaceutical composition can be present in the form of a food product comprising a consortium disclosed herein (e.g., KAN-004). As used herein, the term “food product” refers to a composition intended for ingestion by an individual (e.g., a human subject). Non-limiting examples of food products encompassed by the present disclosure include juices, refreshing beverages, tea beverages, drink preparations, jelly beverages, functional beverages, milk, dairy beverages, ice creams, cheeses, yogurts, biscuits,20 cookies, candies, chewing gums, gummies, jellies, cream caramels, frozen desserts, and instant foods. Further, the examples also include health foods and beverages prepared in the forms of powders, granules, tablets, capsules, liquids, pastes, and jellies. In certain embodiments, the food product comprising a presently disclosed consortia further comprises a prebiotic. As used herein, the term “prebiotic” refers to a substance that can promote the growth of the microbes of the25 consortia. Non-limiting examples of prebiotic include fructose, galactose, mannose, soy, inulin, dietary fibers, or a combination thereof.In certain embodiments, microbial cells of the present disclosure are harvested by microfiltration and centrifugation. In certain embodiments, microfiltration is done with a membrane comprising a nonreactive polymer. For example, in certain non-limiting embodiments, said membrane comprises Polyvinylidene fluoride, Polysulfones, or nitrocellulose. In certain embodiments, a membrane for microfiltration has a pore size from about 0.2 pm to about 0.45 pm. In certain embodiments, the cells are centrifuged at from about 1000 g to about 30000 g, from about 5000 g to about 30000 g, from about 10000 g to about 30000 g, from about 15000 g to about 30000 g, from about 20000 g to about 30000 g, from about 25000 g to about 30000 g,35 from about 1000 g to about 25000 g, from about 5000 g to about 25000 g, from about 10000 g toACTIVE 511662979.2 73PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT about 25000 g, from about 15000 g to about 25000 g, from about 20000 g to about 25000 g, from about 1000 g to about 20000 g, from about 5000 g to about 20000 g, from about 10000 g to about 20000 g, from about 15000 g to about 20000g, from about 1000 g to about 15000 g, from about 5000 g to about 15000 g, from about 10000 g to about 15000 g, from about 1000 g to about 100005 g, from about 5000 g to about 10000 g, or from about 1000 g to about 5000 g force.In certain embodiments, the cells are concentrated to from about 1 x 106CFUs per milliliter to about 1 x 1012CFUs per milliliter, from about 1 x 107CFUs per milliliter to about 1 x 1012CFUs per milliliter, from about 1 x 108CFUs per milliliter to about 1 x 1012CFUs per milliliter, from about 1 x 109CFUs per milliliter to about 1 x 1012CFUs per milliliter, from about10 1 x io10CFUs per milliliter to about 1x1012CFUs per milliliter, from about 1x1011CFUs per milliliter to about 1x1012CFUs per milliliter, from about 1 x 106CFUs per milliliter to about 1 x 1011CFUs per milliliter, from about 1x107CFUs per milliliter to about 1x1011CFUs per milliliter, from about 1 x 108CFUs per milliliter to about 1x1011CFUs per milliliter, from about 1 x io9CFUs per milliliter to about 1x1011CFUs per milliliter, from about 1x1O10CFUs per milliliter to about 1x1011CFUs per milliliter, from about 1 x 106CFUs per milliliter to about 1 x 1010CFUs per milliliter, from about 1 x 107CFUs per milliliter to about 1x1O10CFUs per milliliter, from about 1 x 108CFUs per milliliter to about 1 x 1O10CFUs per milliliter, from about 1 x io9CFUs per milliliter to about 1x1O10CFUs per milliliter, from about 1 x 106CFUs per milliliter to about 1 x 109CFUs per milliliter, from about 1 x 107CFUs per milliliter to about 1x20 109CFUs per milliliter, from about 1x108CFUs per milliliter to about 1x109CFUs per milliliter, from about 1 x 106CFUs per milliliter to about 1 x 108CFUs per milliliter, from about 1 x 107CFUs per milliliter to about 1 x 108CFUs per milliliter, or from about 1 x 106CFUs per milliliter to about 1 x 107CFUs per milliliter.In certain embodiments, microbial cells of the present disclosure are frozen. In certain embodiments, the microbial cells of the present disclosure are mixed with one or more cryoprotective agents (CPAs) before freezing. In certain embodiments, the ratio of cells to CPA is approximately 25: 1, 10: 1, 5: 1, 4: 1, 3: 1, 2: 1, 1 : 1, 1 :2, 1 :3, 1 :4, 1 :5, 1 : 10, or 1 :25. In certain embodiments, a CPA comprises one or more of glycerol, maltodextrin, sucrose, inulin, trehalose, and alginate. In certain embodiments, a CPA further comprises one or more antioxidants. In30 certain embodiments, an antioxidant is selected from the list of cysteine, ascorbic acid, and riboflavin.9. Functionally Equivalent and Identical Drug Products to KAN-004The strains included in KAN-004 are described herein by 16S RNA sequences and functional characteristics. Based on this, equivalent Consortia to KAN-004 (or FB-003) can beACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT generated by screening multiple of the same strain to find equivalent strains with equivalent function to those that comprise FB-003. Accordingly, identical strains may theoretically have different functions, strains can be screened using 16S RNA and Biolog as described herein to identify functionally identical and equivalent strains from any fecal collection using the methods5 of collection described herein.It is important to note that KAN-004 was articulately designed to have multiple of the same strain in the Consortia. The reason for this to have redundancy to ensure function; however, such redundancy is not required for equivalent function so long as one of the otherwise redundant strains is included in the final drug product at a sufficient viable cell count amount to achieve in10 vivo function in a subject. Accordingly, a Consortia that is equivalent or identical to KAN-004 may contain all redundancies (see Table 1) or alternatively may contain no or fewer redundancies per strain so long as the included strains achieve in vivo function in a subject. / 0. Combination TherapyIn certain embodiments, a Consortia can be administered in combination with other agents. In certain embodiments, a Consortia can be administered with an antimicrobial agent, an antifungal agent, an antiviral agent, an antiparasitic agent, a food, a drink, a probiotic, or a prebiotic. In certain embodiments, a Consortia can be administered subsequent to administration of an antimicrobial agent, an antifungal agent, an antiviral agent, an antiparasitic agent or a prebiotic. In certain embodiments, administration may be sequential over a period of hours or20 days, or simultaneously.For example, in certain non-limiting embodiments, a microbial consortium can be administered with, or pre-administered with, one or more antibacterial agent selected from fluoroquinolone antibiotics (ciprofloxacin, Levaquin, floxin, tequin, avelox, and norflox); cephalosporin antibiotics (cephalexin, cefuroxime, cefadroxil, cefazolin, cephalothin, cefaclor, cefamandole, cefoxitin, cefprozil, and ceftobiprole);penicillin antibiotics (amoxicillin, ampicillin, penicillin V, dicloxacillin, carbenicillin, vancomycin, and methicillin); tetracycline antibiotics (tetracycline, minocycline, oxytetracycline, and doxycycline); and carbapenem antibiotics (ertapenem, doripenem, imipenem / cilastatin, and meropenem).For example, in certain non-limiting embodiments, a microbial consortium can be30 administered with one or more antiviral agent selected from Abacavir, Acyclovir, Adefovir, Amprenavir, Atazanavir, Cidofovir, Darunavir, Delavirdine, Didanosine, Docosanol, Efavirenz, Elvitegravir, Emtricitabine, Enfuviltide, Etravirine, Famciclovir, Foscamet, Fomivirsen, Ganciclovir, Indinavir, Idoxuridine, Lamivudine, Lopinavir Maraviroc, MK-2048, Nelfinavir, Nevirapine, Penciclovir, Raltegravir, Rilpivirine, Ritonavir, Saquinavir, Stavudine, TenofovirACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Trifluridine, Valaciclovir, Valganciclovir, Vidarabine, Ibacitabine, Amantadine, Oseltamivir, Rimantidine, Tipranavir, Zalcitabine, Zanamivir, and Zidovudine.In certain embodiments, a microbial consortium can be administered with one or more antifungal agent selected from miconazole, ketoconazole, clotrimazole, econazole, omoconazole,5 bifonazole, butoconazole, fenticonazole, isoconazole, oxiconazole, sertaconazole, sulconazole, and tioconazole; triazole antifungals such as fluconazole, itraconazole, isavuconazole, ravuconazole, posaconazole, voriconazok, terconazole, and albaconazole; thiazole antifungals such as abafungin; allylamine antifungals such as terbinafine, naftifine, and butenafine; and echinocandin antifungals such as anidulafungin, caspofungin, and micafungin; polygodial;10 benzoic acid; ciclopirox; tolnaftate; undecylenic acid; flucytosine or 5 -fluorocytosine; griseofulvin; and haloprogin.In certain embodiments, a microbial consortium can be administered with one or more anti-inflammatory and / or immunosuppressive agent selected from cyclophosphamide, mycophenolate mofetil, corticosteroids, mesalazine, mesalamine, sulfasalazine, sulfasalazine derivatives, cyclosporin A, mercaptopurine, azathiopurine, prednisone, methotrexate, antihistamines, glucocorticoids, epinephrine, theophylline, cromolyn sodium, anti-leukotrienes, anticholinergics, monoclonal anti-IgE, immunomodulatory peptides, immunomodulatory small molecules, immunomodulatory cytokines, immunomodulatory antibodies, and vaccines.In certain embodiments, a Consortia can be administered with one or more prebiotic20 selected from, but not limited to, amino acids, biotin, fructooligosaccharides, galactooligosaccharides, inulin, lactulose, mannan oligosaccharides, oligofructose-enriched inulin, oligofructose, oligodextrose, tagatose, trans-galactooligosaccharide, and xylooligosaccharides.In certain embodiments, a Consortia described herein is administered in combination with an anti-inflammatory drug.In certain embodiments, a Consortia described herein is administered in combination with an anti -diarrheal drug.In certain embodiments, a Consortia described herein is administered in combination with a pain reliever. In certain embodiments, a Consortia described herein is administered in30 combination with a nonsteroidal anti-inflammatory drug (NSAIDs).In certain embodiments, a Consortia described herein is administered in combination with vitamins and supplements.In certain embodiments, a Consortia described herein is administered in combination with aminosalicylates.ACTIVE 511662979.2 76PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT In certain embodiments, a Consortia described herein is administered in combination with antibiotics.In certain embodiments, a Consortia described herein is administered in combination with biologies. In certain embodiments, the biologies interrupt signals from the immune system that5 cause inflammation.In certain embodiments, a Consortia described herein is administered in combination with corticosteroids or steroids.In certain embodiments, a Consortia described herein is administered in combination with immunomodulators .In certain embodiments, a Consortia described herein is administered in combination with any of the immune checkpoint inhibitors disclosed herein (see Sections 2 and 3).In certain embodiments, the combination treatment of a Consortia comprises the pretreatment with antibiotics. In certain embodiments, the pretreatment of antibiotics.In certain embodiments, a bowel preparation (e.g., MiraLax) is administered in the late15 afternoon or early evening following the final dose of antibiotics.11. KitsThe presently disclosed subject matter provides kits for treating or preventing an immune- associated adverse event. In certain embodiments, the immune-associated adverse event is colitis. In certain embodiments, the subject has received or will receive an immunotherapy including an20 immune checkpoint inhibitor (ICI) . In certain embodiments, the kit comprises an effective amount of presently disclosed Consortia or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of KAN-004 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to KAN-004 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to KAN-004 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS1 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount30 of a functionally equivalent Consortia to DS1 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS1 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS2 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amountACTIVE 511662979.2 77PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT of a functionally equivalent Consortia to DS2 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS2 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS3 or a pharmaceutical5 composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS3 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS3 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS4 or a pharmaceutical10 composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS4 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS1 and DS2 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS1 and DS2 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS1 and DS2 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS1 and DS3 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS1 and DS3 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS1 and DS3 or a pharmaceutical composition comprising25 thereof.In certain embodiments, the kit comprises an effective amount of DS1 and DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS1 and DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS1 and DS4 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS2 and DS3 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS2 and DS3 or a pharmaceutical35 composition comprising thereof. In certain embodiments, the kit comprises an effective amountACTIVE 511662979.2 78PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT of a functionally identical Consortia to DS2 and DS3 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS2 and DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an5 effective amount of a functionally equivalent Consortia to DS2 and DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS2 and DS4 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS3 and DS4 or a10 pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS3 and DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS3 and DS4 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS1, DS2, and DS3 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS1, DS2, and DS3 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS1, DS2, and DS3 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS1, DS2, and DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS1, DS2, and DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount25 of a functionally identical Consortia to DS1, DS2, and DS4 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises an effective amount of DS2, DS3, and DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally equivalent Consortia to DS2, DS3, and DS4 or a pharmaceutical composition comprising thereof. In certain embodiments, the kit comprises an effective amount of a functionally identical Consortia to DS2, DS3, and DS4 or a pharmaceutical composition comprising thereof.In certain embodiments, the kit comprises a sterile container; such containers can be boxes, ampules, bottles, vials, tubes, bags, pouches, blister-packs, or other suitable container forms35 known in the art. Such containers can be made of plastic, glass, laminated paper, metal foil, orACTIVE 511662979.2 79PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT other materials suitable for holding medicaments. In certain non-limiting embodiments, the kit includes anaerobic containers to hold the Consortia(s) described herein. In certain non-limiting embodiments, the kit includes blister packs to hold the Consortia(s) described herein in the presence of no or limited amounts of oxygen. In certain non-limiting embodiments, the kit5 includes blister packs with desiccant to hold the Consortia(s) described herein in the presence of no or limited amounts of oxygen. In certain non-limiting embodiments, the kit includes bottles with desiccant to hold the Consortia(s) described herein in the presence of no or limited amounts of oxygen.In certain embodiments, the kits include instructions for administering the Consortia as10 described herein. In certain embodiments, the instructions include directions for administering the loading and the maintenance dose.In certain embodiments, the kits include storage instructions. In certain embodiments, the storage instructions are for storage at approximately -20°C. In certain embodiments, the storage instructions are for storage at less than -5°C. In certain embodiments, the storage instructions are for storage at less than approximately -15 to -20°C, -10 to -20°C, -10 to -15°C, -5 to -10°C, 0 to - 5°C, below 0°C, or 0 to -20°C. In certain embodiments, the storage instructions are for storage at less than approximately 4°C. In certain embodiments, the storage instructions are for storage at room temperature.In certain embodiments, the kits include instructions for maintaining the Consortia in no20 or low oxygen conditions.In certain embodiments, the kits include instructions for the subject to remain off all antibiotics during treatment with the Consortia.In certain embodiments, the kit includes KAN-004 and instructions for administering the same.Additional information on the presently disclosed Consortia and on the manufacturing methods and kits comprising the same can be found in International Patent Application Nos. PCT / US2022 / 051477 and PCT / US2024 / 019341, the contents of each of which is incorporated by reference in their entireties.EXAMPLES30 Example 1Mice pre-treated with antibiotics exhibit a loss of epithelial barrier and extensive mucosal ulceration, severe inflammation, and diffuse crypt loss and distortion after DSS treatment. Figure 3. Administration of KAN-004 to the mice pre-treated with antibiotics resulted in improvedACTIVE 511662979.2 80PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT intestinal barrier integrity. Survival plots of animals treated with KAN-004 in the context antibiotic pre-treatment in a DSS- induced colitis mouse model resulted in a decrease in mortality from 90% for the mice receiving a vehicle control to 20% mortality for mice receiving KAN-004. Figure 3.5 Example 2Mice treated with antibiotics provides a model for dysbiosis that can and does occur in patients. Following antibiotic treatment, residual surviving microbes will re-bloom in a mouse gut. This process results in metabolic signatures that differ drastically from a healthy mouse gut metabolome (Figures 4A and 4B). Prior to antibiotics treatment, short chain fatty acids (SCFAs) show a characteristic profile that includes in order of concentration: propionate, butyrate, valerate, isobutyrate, isovalerate. These metabolites were not detected at days 0 - 4 post-antibiotics treatment in the vehicle group, and were detected at days 7,9, but at dysbiotic proportions. In contrast, in KAN-004 gavaged mice, SCFAs were detected as early as day 2 and show a normal profile as early as day 7. These correlate well with the pre-antibiotics metabolic status. A similar15 trend was observed with bile acids, where in a healthy gut conjugated bile acids are converted by the microbiome into primary and secondary bile acids. This modification detoxifies the BAs as they traverse the gut. In the vehicle treatment group, conjugated bile acids make up all or most of the bile acid pool for several days post-antibiotics, whereas the KAN-004 treatment group recovers primary and secondary bile acids rapidly (Figure 4B).20 Example 3GF / MCA205 ICI interference assessmentUsing a C57BL / 6 germ-free (GF) MCA205 fibrosarcoma mouse model, the impact of KAN-004 therapeutic on response to immune checkpoint inhibitor (ICI) therapy was tested relative to control (Figure 6). Germ-free female C57BL / 6 mice, 6 weeks old, were used for the study. Upon arrival, the mice underwent an acclimation period from day -19 to day -19. On day - 15 and day -15, the mice were administered material by oral gavage, either positive control responder fecal material or KAN-004 lyophilized material resuspended in PBS buffer. From day -13 to day -1, mice were given time for the microbial consortia to engraft and stabilize, as well as provide time for the mouse immune system to respond and achieve homeostasis with the gut30 residents.On day 0, baseline fecal samples were collected and the mice received a subcutaneous injection of MCA-205 cells. Mice were randomized on day +6 and the first injection of anti-PDl administered. Anti-PD-1 was administered on days +6, +9, +12, and +15, with feces collectionACTIVE 511662979.2 81PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT occurring on these days as well. Throughout the study, body weights and tumor growth were monitored to assess the impact of the treatments. The study was ended on day +17, and final samples including feces and organs were collected for further analysis.The top line results were that tumor growth was observed to reach an average of -1005 mm3 in the KAN-004 treated mice, whereas tumor growth was observed to reach an average of >150 mm3 in the positive control benchmark responder treated mice (Figure 7A). Further, the KAN-004 treated mice had smaller average tumor volumes throughout the study, including on day +6, which is the first time that mice were provided anti-PDl (Figure 7B). To confirm overall mouse health, body weights were taken at every timepoint where anti-PDl was provided and10 measurements were consistently near 20 g / mouse across both groups, indicating safe and stable animal health (Figure 7C). The results demonstrated that KAN-004 outperforms the benchmark responder, indicating enhanced therapeutic efficacy when combined with ICIs.Example 4SPF / EO771 ICI interference assessmentSummary. KAN-004 was designed to be an oral investigational therapeutic, delivered in capsules, comprising a consortium of 145 microbial strains as set forth in Figures 5A-5C and Figure 11. It was designed to transplant a healthy microbiome to patients with cancer experiencing immune-related diarrhea or colitis (irColitis) induced by immune checkpoint inhibitors (ICIs). KAN-004 was further designed to treat irColitis in patients with cancer to replace the unhealthy20 gut microbiome (dysbiosis) associated with irColitis with a complete, healthy consortium of GI commensal microorganisms.Furthermore, this study was designed to investigate, and proved, the ability of KAN-004 to induce tumor growth inhibition in combination with anti-programmed cell death protein 1 (PD- 1) treatment in a tumor model. E0771 breast cancer cells are a cell line resistant to anti-PD-1 and have been used to evaluate microbiome therapies with ability to reduce the resistance to anti-PD- 1 (Error! Reference source not found. 2019).Eight- week-old specific pathogen-free (SPF) female C57BL / 6 mice were acclimated for four days, before treatment over three days with an antibiotic solution containing ampicillin, streptomycin, and colistin. At Day- 15, the mice received two consecutive oral gavages of30 KAN-004 consortium, fecal suspension from a responder (R) non-small cell lung cancer (NSCLC) patient amenable to ICI or fecal suspension from a non-responder (NR) NSCLC amenable to ICI. Two weeks after the gavage, E0771 tumor cells were injected subcutaneously (SC) into the right flank of mice. Ten days later, the mice were treated with anti-PD-1 antibody or isotype control,ACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT administered intraperitoneal (IP) on Day 10, Day 13, Day 16, Day 19, Day 22 and Day 26. Tumor size was measured by caliper.Tumor sizes at Day 10 pre-ICI treatment were significantly reduced in the KAN-004 group compared to both the ICI R (p = 0.026) and NR (p = 0.002) fecal microbiota transplantation (FMT)5 groups, with 5 of 10 animals showing no measurable tumor. These results demonstrated KAN- 004’ s efficacy in suppressing tumor progression as a single agent. At Day 28, a near significant difference in tumor size (p = 0.055) was observed between KAN-004 + anti-PD-1 group and KAN-004 + isotype control group, while no significant difference between anti-PD-1 and isotype treatment was observed in the R, NR, or no microbiome treatment groups.10 T cells play a central role in the immune system’s ability to recognize and respond to cancer cells. Cytotoxic cluster of differentiation (CD)8+ T cells can directly kill tumor cells, while effector memory T cells (TEMs) contribute to long-term tumor control. On the other hand, regulatory T cells (Tregs) can suppress immune activity, helping tumors evade detection (Error! Reference source not found. 2009). Immune cell levels within tumors can indicate how the immune system is influencing cancer growth or response to therapy, therefore, tumor immune cell profile was analyzed. Combination anti-PD-1 treatment with both control NR FMT and KAN-004 led to increases in tumor infiltrating CD8+ T cells and TEMs compared to NR FMT and KAN- 004 treatment alone. The increase observed in anti-PD-1 + KAN-004 was significantly greater than KAN-004 alone in both cases (p = 0.008, p = 0.03), whereas anti-PD-1 + NR FMT showed20 an upward trend in both cases that was near significance (p = 0.055, p = 0.055). Similarly, the ratio of CD8+ T cells to Tregs was significantly increased by anti-PD-1 + KAN-004 treatment compared to KAN-004 treatment alone (p = 0.003), whereas a significant increase was not observed in anti-PD-1 + NR FMT compared to NR FMT alone.These data further support that KAN-004 in combination with ICI treatment in murine25 models shows safety and the potential to elicit a tumor response to ICI treatment that is superior to FMT in combination with ICI treatment or ICI treatment alone.Study Plan and Results. To further examine the impact observed in the GF / MCA205 model, a second tumor model was employed in the study. In this study, specific pathogen-free (SPF) mice were used. Mice underwent antibiotic pre-treatment to reduce the biomass and decrease native microbiome diversity. Finally, the EO771 cell line, a breast cancer adenocarcinoma, was utilized because it lacks PD-1 sensitivity, all of which together provide a high bar for observation of efficacy and a second method for assessing the potential for immune system suppression or stimulation from KAN-004.Mice underwent an acclimation period from day -22 to day -19. On day -19 until day -16,35 drinking water was changed so that mice were pre-treated with a cocktail of colistin, ampicillin,ACTIVE 511662979.2 83PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT and streptomycin antibiotics to reduce their native microbiota. Consortia were gavaged on days - 15 and -14, with groups receiving either non-responder (NR), responder I, KAN-004, or no treatment. On day 0, the EO771 cells were subcutaneously injected into the mice on their flank. Tumor growth was monitored throughout the study and fecal samples were collected at regular5 intervals. Starting with randomization on day 10, mice received anti-PD-1 treatment on days 7, +10, +13, and +16. Body weights and feces were also collected at these times. On day 21, the mice were sacrificed, and both feces and organs were collected for further analysis. Tumor volumes were measured throughout the study to evaluate the effects of KAN-004 and its potential to induce PD-1 sensitivity in the EO771 cell line (Figure 8A-8B).10 There were several interesting observations. First, D+10, the 10 KAN-004 treated animals were found to have lower tumor volumes than either of the other groups, with 5 / 10 tumors in this group immeasurable (Figure 9A). Next, at EOS the anti-PD-l / KAN-004 co-treatment group showed significantly smaller tumor volumes than the isotype control with KAN-004. No other group showed significant separation between anti-PD-1 and isotype treatments. These data indicate that not only does KAN-004 not interfere, but that it further induced PD-1 sensitivity in the EO771 cell line, as indicated by significantly smaller tumor volumes in the KAN-004 treated group compared to the isotype control group by day 21 (Figure 9B). Body weight measurements were indistinguishable between the groups, increasing over the study as expected after an antibiotics course, from 16 to 20 g / mouse (Figure 9C). Strikingly, KAN-004 exhibited significant20 single-agent activity, with lower tumor volumes observed prior to ICI treatment on day +10, suggesting re-modeling of the immune system to promote anti-tumor properties. These findings support the utility of KAN-004 as an ICI colitis therapy.Of note, previous studies indicated that in a DSS colitis model, KAN-004 treatment reduces inflammation and clinical pathology in the gut, acting locally to suppress immune25 response through the maintenance of gut barrier and presence of metabolites such as butyrate that nourish gut epithelial cells. Interestingly, while acting as an immunosuppressive locally, this community acts as an immunostimulant globally. To test this idea, tumors harvested at end of study were examined with flow cytometry to identify the immune cell profiles (Figure 10). An increased ratio of CD8 / Treg, an increased CD8+ % and an increased CD8+ effector memory T cell (TEM) population relative to the non-responder FMT control was observed. These data support our hypothesis that the diverse microbiome provided by KAN-004 can suppress inflammation in the local immune response in gut tissue while also freeing CD8+ cells to leave the gut and respond swiftly to tumor signaling.Conclusion. When combined with anti-PD-1 therapy in an E0771 ICI-resistant breast35 cancer cell line tumor model, utilizing C57BL / 6 SPF mice, KAN-004 outperformed responderACTIVE 511662979.2 84PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT FMT through both single agent activity (prior to ICI initiation) and dual agent activity (during ICI treatment). KAN-004 treatment significantly reduced tumor size prior to ICI administration and showed a strong trend toward enhancing anti-PD-1 efficacy compared to control treatments, highlighting its potential to suppress tumor progression and improve immunotherapy response.5 Combination immunotherapy and KAN-004 treatment significantly enhanced tumor-infiltrating CD8+ T cells, effector memory T cells, and the CD8 / Treg ratio compared to KAN-004 alone, more so than NR FMT controls, suggesting a more potent and durable antitumor response through increased infiltration of cytotoxic cells and reduced immunosuppression. Taken together, these data further support that KAN-004 in combination with ICI treatment in murine models shows10 safety and the potential to elicit a tumor response to ICI treatment that is superior to FMT in combination with ICI treatment or ICI treatment alone.Example 5Phase I clinical study in human, healthy volunteers of related FB-001 communityTo assess the safety of the strains, phase I clinical study in healthy, human volunteers was designed and conducted. The clinical study examined a related community of 148 strains. The 148 strain community differed from KAN-004 in that it contained 3 additional strains of Oxalobacter formigenes. Thus, this phase I study can be considered to be an accurate assessment of the safety of all 145 strains in the KAN-004 community. There were a few mild adverse events (AEs) in both the treatment and placebo control groups. There was one moderate AE in the treatment group,20 and was attributed to the patient experiencing the AE contracting COVID19 prior to their EOS visit.Example 6Clinical dosing and treatment using KAN-004 for the treatment of immune-related diarrhea and / or colitis induced by ICI therapySummary. KAN-004 is a uniquely designed, complex consortium designed to replace dysbiosis of the human GI tract with a safe, reproducible and metabolically complete microbiome therapeutic. The species in the consortium span seven of the major phyla found in the GI tracts of healthy adults. The consortium was not modeled after or derived from any individual natural community, rather it is a diverse curated collection of common GI microbes isolated from healthy,30 rigorously screened donors and enriched for species performing beneficial or normalizing functions. The diverse, comprehensive nature of the consortium was designed to encourage robust and durable engraftment of KAN-004 and perform the intended functions of key microbialACTIVE 511662979.2PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT metabolisms, gut barrier function and immune homeostasis, regardless of differences in patient physiology or diet.Finding more effective therapies for the treatment of irColitis not associated with side effects related to immunosuppression, as well as allowing clinicians to safely resume ICI,5 represents an urgent unmet medical need. The gut microbiome has emerged as a promising target for the treatment of irColitis. These proof-of-concept FMT studies and others have demonstrated that modulation of the gut microbiome is amongst the most promising strategies to treat irColitis given clinical successes with FMT in the steroid-naive and refractory settings. KAN-004 is a live microbial product that was designed to mimic a healthy human donor microbiome and allows for10 a scalable solution to overcome the known challenges and limitations of FMT, including scalability, reproducibility, and risk of transmission of infection. KAN-004 has demonstrated safety in preclinical studies as well as the ability to restore gut epithelial barrier integrity and reduce colonic inflammation in a preclinical colitis model as described in Examples 4 and 5.Dosing. KAN-004 was designed to be dosed according to the schedule set forth in Table 7. Furthermore, KAN-004 was designed to be taken orally with water, and preferably with meals / food. While the safety profile was established for KAN-004 as described in Examples 4 and 5 and dosing of patients does not need to be limited by time (z.e., dosing could continue for a non-preset amount of time and could continue so long as the patient is receiving benefit), KAN- 004 can be administered for a total of 1 month, 2 months, 3 months, 4 months, 5 months, or 620 months for the treatment of immune-related diarrhea or colitis induced by ICI therapy. In certain embodiments, such treatment was designed using the dosing schemes set forth in Table 7.In addition to oral administration, KAN-004 can be administered through a colonoscopy and salvage. Specifically, if a patient requires or could benefit from bowel preparation for sigmoidoscopy or colonoscopy (including but not limited to benefits of administering KAN-004), KAN-004 can be administered by “salvage” (i.e., colorectal) concurrent or following the colonoscopy.Accordingly, KAN-004 was designed to mitigate colitis symptoms and facilitate the safe, reintroduction of ICI therapy.30 Table 7. Oral dosing scheme for use in the clinical administration of KAN-004ACTIVE 511662979.2 86PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTIn light of the safety shown for the strains of KAN-004 as described in Examples 4 and 5, the dosing of KAN-004 described in Table 7 could be modified to increase the dosing. It is contemplated that the loading dose could be up to doubled to achieve maximal effect in humans.5 It is contemplated that the maintenance dose could be increased by 2x, 3x, 4x, or up to 5x (same as the loading dose set forth in Table 7).* * *While the present invention has been described at some length and with some particularity 10 with respect to the several described embodiments, it is not intended that it should be limited to any such particulars or embodiments or any particular embodiment, but it is to be construed with references to the appended claims so as to provide the broadest possible interpretation of such claims in view of the prior art and, therefore, to effectively encompass the intended scope of the invention.15 All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, section headings, the materials, methods, and examples are illustrative only and not intended to be limiting.ACTIVE 511662979.2 87

Claims

PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENTCLAIMS:

1. A plurality of microbes comprising the microbes set forth in Figures 5 A-5C.

2. A plurality of microbes consisting of the microbes set forth in Figures 5A-5C.

3. A plurality of microbes comprising strains of the microbes set forth in Figure 11.

4. A plurality of microbes consisting of strains of the microbes set forth in Figure 11.

5. A pharmaceutical composition comprising the plurality of microbes of any one of claims 1-4, wherein the pharmaceutical composition comprises between about 1 x 107and about 1 x 1013viable cells, between about 1 x 108and about 1 x io13viable cells, between about 1 x io9and about 1 x io13viable cells, between about 1 x io10and about 1 x io13viable cells, between about 1 x io11and about 1 x io13viable cells, between about 1 x io12and about 1 x io13viable cells, between about 1 x io7and about 1 x io12viable cells, between about 1 x io7and about 1 x io11viable cells, between about 1 x io7and about 1 x io10viable cells, between about 1 x io7and about 1 x io9viable cells, between about 1 x io7and about 1 x io8viable cells, between about 1 x io8and about 1 x io9viable cells, between about 1 x io9and about 1 x io10viable cells, between about 1 x io11and about 1 x io12viable cells, between about 1 x 1012and about 1 x io13viable cells, between about 5 x io9and about 5 x io10viable cells, between about 5 x io10and about 5 x io11viable cells, or between about 5 x io11and about 5 x 1012viable cells.

6. A pharmaceutical composition comprising the plurality of microbes of any one of claims 1-4, wherein the pharmaceutical composition comprises up to about 1011viable cells or up to about 1012viable cells.

7. A method of ameliorating one or more phenotypes associated with an immune-related adverse event in a subject undergoing immunotherapy, the method comprising administering an effective amount of the plurality of microbes of any one of claims 1-4.

8. A method of ameliorating one or more phenotypes associated with an immune-related diarrhea and / or colitis in a subject undergoing immunotherapy, the method comprising administering an effective amount of the plurality of microbes of any one of claims 1-4.

9. A method of ameliorating one or more phenotypes associated with an immune-related diarrhea and / or colitis in a subject in need thereof, the method comprising administering an effective amount of the plurality of microbes of any one of claims 1-4.

10. The method of any one of claims 7-9, wherein the method comprises administering a loading dose and one or more maintenance doses of the plurality of microbes or a pharmaceutical composition thereof.

11. The method of claim 10, wherein the loading dose comprises about 1012viable cells.ACTIVE 511662979.2 88PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT12. The method of claim 10 or 11, wherein the loading dose comprises one or more coated enteric capsules.

13. The method of claim 12, wherein the one or more coated enteric capsules comprise about 1011viable cells.

14. The method of claim 12 or 13, wherein the loading dose comprises 10 coated enteric capsules.

15. The method of any one of claims 10-14, wherein the loading dose is administered for 1 day.

16. The method of any one of claims 10-15, wherein the loading dose is administered twice a day.

17. The method of any one of claims 10-16, wherein the maintenance dose comprises about 2 x 1011viable cells.

18. The method of claim 17, wherein each maintenance dose comprises one or more coated enteric capsules.

19. The method of claim 18, wherein the one or more coated enteric capsules comprise about 1011viable cells.

20. The method of claim 18 or 19, wherein each maintenance dose comprises 2 coated enteric capsules.

21. The method of any one of claims 10-20, wherein the maintenance doses are administered for 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 10 weeks, or 12 weeks following the last loading dose.

22. The method of any one of claims 7-21, wherein the plurality of microbes or the pharmaceutical composition thereof is present in a food product, a probiotic, a prebiotic, or a combination thereof.

23. The method of any one of claims 7-21, wherein the plurality of microbes or the pharmaceutical composition thereof is administered orally or rectally.

24. The method of claim 23, wherein the plurality of microbes or the pharmaceutical composition thereof is administered via colonoscope.

25. A method of ameliorating one or more phenotypes associated with an immune-related adverse event in a subject undergoing immunotherapy, the method comprising administering an effective amount of a microbial consortium or a pharmaceutical composition thereof comprising: a) Clostridium citroniae, Bacteroides salyersiae, Blautia obeum, Parabacteroides merdae, Parabacteroides distasonis, Anaerostipes hadrus, Lachnospiraceae sp. FBI00033 (also known as Lacrimispora amygdalina , Eubacterium eligens, Bifidobacterium dentium, Blautia wexlerae, Fusicatenibacter saccharivorans, Bacteroides nordii, Dorea formicigenerans, Dorea longicatena, BacteroidesACTIVE 511662979.2 89PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT stercorirosoris (also known as Bacteroides oleiciplenus), Bifidobacterium longum, Bacteroides kribbi (also known as Bacteroides koreensis), Lachnospiraceae sp. FBI00071 (also known as Roseburia faecis), Bacteroides thetaiotaomicron, Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also known as Clostridium symbiosum), Coprococcus comes, Blautia faecis, Hungatella hathewayi, Bacteroides stercoris, Collinsella aerofaciens, Hungatella effluvii, Bifidobacterium adolescentis, Bifidobacterium catenulatum, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Bacteroides faecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as Clostridium prolinivorans), Ruminococcus faecis, Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, Butyricimonas faecihominis, Eisenbergiella tayi, Acidaminococcus intestini, Emergencia timonensis, Bifidobacterium pseudocatenulatum, Eubacterium hallii (also known as Anaerobutyricum hallii), Anaerofustis stercorihominis, Eubacterium ventriosum, Blautia hydrogenotrophica, Lachnospiraceae sp. FBI00290 (also known as Eubacterium ruminantium), Acutalibacter timonensis (also known as Neglecta timonensis), Alistipes onderdonkii, Bacteroides uniformis, Eubacterium rectale (also known as Agathobacter rectalis), Alistipes timonensis, Bacteroides kribbi, Coprococcus eutactus, Bilophila wadsworthia, Bacteroides caccae, Alistipes shahii, Parasutterella excrementihominis, Paraprevotella clara, Sutterella wadsworthensis, Sutterella massiliensis, Porphyromonas asaccharolytica, Ruminococcus bromii, Monoglobus pectinilyticus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter pamelaeae, Bacteroides uniformis, Gordonibacter pamelaeae, Bacteroides fragilis, Phascolarctobacterium faecium, Monoglobus pectinilyticus, Clostridium aldenense, Ruthenibacterium lactatiformans, Bacteroides ovatus (also known as Bacteroides koreensis), Bifidobacterium bifidum, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutterella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis), Alistipes senegalensis, Ruminococcaceae sp. FBI00233 (also known as Anaerotruncus colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum, Faecalibacterium prausnitzii, Turicibacter sanguinis, Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, Methanobrevibacter smithii, Bifidobacterium adolescentis (also knownACTIVE 511662979.2 90PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT as Bifidobacterium faecale), Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes,Fusicatenibacter saccharivorans, Eggerthella lenta, Eubacterium eligens,Bacteroides xylanisolvens, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Clostridium citroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenta, Blautia wexlerae (also known as Blautia luti), Lachnoclostridium pacaense, Bacteroides vulgatus, Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis, Anaerostipes hadrus, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolteae, Eisenbergiella tayi, Dorea longicatena, Eggerthella lenta, Bacteroides stercoris, Hungatella hathewayi, Bacteroides xylanisolvens, Alistipes putredinis, Dialister succinatiphilus, Akkermansia muciniphila, Ruminococcus bromii, Dialister invisus, Bacteroides massiliensis, Bilophila wadsworthia, Holdemanella biformis, Parasutterella excrementihominis, Alistipes sp. FBI00180 (also known as Alistipes senegalensis), Bacteroides coprocola, Alistipes sp. FBI00238 (also known as Alistipes finegoldii), Alistipes putredinis, Eubacterium xylanophilum, and Senegalimassilia anaerobia, or a functional equivalent thereof; b) Clostridium citroniae, Bacteroides salyersiae, Blautia obeum, Parabacteroides merdae, Parabacteroides distasonis, Anaerostipes hadrus, Lachnospiraceae sp. FBI00033 (also known as Lacrimispora amygdalina), Eubacterium eligens, Bifidobacterium dentium, Blautia wexlerae, Fusicatenibacter saccharivorans, Bacteroides nordii, Dorea formicigenerans, Dorea longicatena, Bacteroides stercorirosoris (also known as Bacteroides oleiciplenus), Bifidobacterium longum, Bacteroides kribbi (also known as Bacteroides koreensis), Lachnospiraceae sp. FBI00071 (also known as Roseburia faecis), Bacteroides thetaiotaomicron, Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also known as Clostridium symbiosum), Coprococcus comes, Blautia faecis, Hungatella hathewayi, Bacteroides stercoris, Collinsella aerofaciens, Hungatella effluvia (also known as Hungatella effiuvii), Bifidobacterium adolescentis, Bifidobacterium catenulatum, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Bacteroides faecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as Clostridium prolinivorans), Ruminococcus faecis, Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, ButyricimonasACTIVE 511662979.2 91PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT faecihominis, Eisenbergiella tayi, Acidaminococcus inleslini. Emergencia timonensis. Bifidobacterium pseudocatenulatum, Eubacterium hallii (also known as Anaerobutyricum hallii), Anaerofustis slercorihominis, Eubacterium ventriosum, Blautia hydrogenotrophica, and Lachnospiraceae sp. FBI00290 (also known as Eubacterium ruminantium), or a functional equivalent thereof; c) Acutalibacter timonensis (also known as Neglecta timonensis), Alistipes onderdonkii, Bacteroides uniformis, Eubacterium rectale (also known as Agathobacter rectalis), Alistipes timonensis, Bacteroides kribbi, Coprococcus eutactus, Bilophila wadsworthia, Bacteroides caccae, Alistipes shahii, Parasutterella excrementihominis, Paraprevotella clara, Sutterella wadsworthensis, Sutterella massiliensis, Porphyromonas asaccharolytica, Ruminococcus bromii, Monoglobus pectinilyticus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter pamelaeae, Bacteroides uniformis, Gordonibacter pamelaeae, Bacteroides fragilis, Phascolarctobacterium faecium, Monoglobus pectinilyticus, Clostridium aldenense, Ruthenibacterium lactatif ormans, Bacteroides ovatus (also known as Bacteroides koreensis), Bifidobacterium bifidum, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutterella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis), Alistipes senegalensis, Ruminococcaceae sp. FBI00233 (also known as Anaerotruncus colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum, Faecalibacterium prausnitzii, Turicibacter sanguinis, Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, and Methanobrevibacter smithii, or a functional equivalent thereof; d) Bifidobacterium adolescentis (also known as Bifidobacterium faecale), Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes, Fusicatenibacter saccharivorans, Eggerthella lenta, Eubacterium eligens, Bacteroides xylanisolvens, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Clostridium citroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenta, Blautia wexlerae (also known as Blautia luti), Lachnoclostridium pacaense, Bacteroides vulgatus, Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis, Anaerostipes hadrus, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolteae, Eisenbergiella tayi, Dorea longicatena, Eggerthella lenta, BacteroidesACTIVE 511662979.2 92PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENT stercoris, Hungatella hathewayi, and Bacteroides xylanisolvens or a functional equivalent thereof; e) Alistipes pulredinis, Dialister succinaliphihis. Akkermansia muciniphila. Ruminococcus bromii. Dialister invisus, Bacteroides massiliensis, Bilophila wadsworthia, Holdemanella biformis, Parasutterella excremenlihominis. Alistipes sp. FBI00180 (also known as Alistipes senegalensis), Bacteroides coprocola, Alistipes sp. FBI00238 (also known as Alistipes finegoldii), Alistipes pulredinis. Eubacterium xylanophilum, and Senegalimassilia anaerobia or a functional equivalent thereof; f) Bifidobacterium adolescentis, Bifidobacterium bifidum, Bifidobacterium calenulalum. Bifidobacterium denln' im, Bifidobacterium faecale. Bifidobacterium longum. Bifidobacterium pseudocatenulatum, Collinsella aerofaciens. Eggerthella lenla, Gordonibacter pamelaeae, Senegalimassilia anaerobia, Alistipes finegoldii, Alistipes onderdonkii, Alistipes pulredinis, Alistipes senegalensis, Alistipes shahii, Alistipes timonensis, Bacteroides caccae, Bacteroides coprocola, Bacteroides faecis, Bacteroides finegoldii, Bacteroides fragilis, Bacteroides koreensis, Bacteroides kribbi, Bacteroides massiliensis, Bacteroides nordii, Bacteroides oleiciplenus, Bacteroides salyersiae, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides xylanisolvens, Barnesiella intestinihominis, Butyricimonas faecihominis, Parabacteroides distasonis, Parabacteroides merdae, Paraprevotella clara, Phocaeicola vulgatus, Porphyromonas asaccharolytica, Methanobrevibacter smithii, Acidaminococcus intestini, Agathobacter rectalis, Anaerobutyricum hallii, Anaerofustis stercorihominis, Anaerostipes hadrus, Anaerotruncus colihominis, Blautia faecis, Blautia hydrogenotrophica, Blautia luti, Blautia obeum, Blautia wexlerae, Christensenella hongkongensis, Clostridium aldenense, Clostridium bolteae, Clostridium citroniae, Clostridium clostridioforme, Clostridium prolinivorans, Clostridium scindens, Clostridium symbiosum, Coprococcus comes, Coprococcus eutactus, Dialister invisus, Dialister succinatiphilus, Dielma fastidiosa, Dorea formicigenerans, Dorea longicatena, Eisenbergiella tayi, Emergencia timonensis, Eubacterium eligens, Eubacterium ruminantium, Eubacterium siraeum, Eubacterium ventriosum, Eubacterium xylanophilum, Faecalibacterium prausnitzii, Fusicatenibacter saccharivorans, Holdemanella biformis, Hungatella effluvii, Hungatella hathewayi, Lachnoclostridium pacaense, Lachnospira pectinoschiza, Lacrimispora amygdalina, Longicatena caecimuris, Megasphaera massiliensis, Merdimmobilis hominis, Monoglobus pectinilyticus, Neglecta timonensis, Phascolarctobacterium faecium, Roseburia faecis, Roseburia hominis, RuminococcusACTIVE 511662979.2 93PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT bromii. Ruminococcus faecis, Ruthenibacterium lactatif ormans, Turicibacter sanguinis, Parasutterella excremenlihominis, Sutterella massiliensis, Sutterella wadsworthensis, Bilophila wadsworthia, Akkermansia muciniphila, or a functional equivalent thereof; g) FBI00001, FBI00002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033,FBI00034, FBI00043, FBI00044, FBI00048, FBI00050, FBI00051, FBI00057,FBI00059, FBI00060, FBI00070, FBI00071, FBI00076, FBI00079, FBI00087,FBI00093, FBI00102, FBI00109, FBI00117, FBI00120, FBI00125, FBI00127,FBI00128, FBI00145, FBI00162, FBI00174, FBI00184, FBI00190, FBI00191,FBI00194, FBI00198, FBI00199, FBI00200, FBI00201, FBI00205, FBI00206,FBI00211, FBI00220, FBI00221, FBI00236, FBI00245, FBI00248, FBI00251,FBI00254, FBI00267, FBI00278, FBI00288, FBI00290, FBI00004, FBI00012,FBI00015, FBI00018, FBI00019, FBI00021, FBI00038, FBI00040, FBI00046,FBI00061, FBI00066, FBI00075, FBI00077, FBI00080, FBI00081, FBI00085,FBI00092, FBI00097, FBI00099, FBI00112, FBI00132, FBI00137, FBI00140,FBI00149, FBI00151, FBI00176, FBI00189, FBI00197, FBI00208, FBI00212,FBI00224, FBI00226, FBI00229, FBI00233, FBI00235, FBI00237, FBI00243,FBI00244, FBI00258, FBI00260, FBI00263, FBI00270, FBI00273, FBI00277,FBI00292, FBI00009, FBI00011, FBI00016, FBI00020, FBI00025, FBI00027,FBI00030, FBI00047, FBI00052, FBI00053, FBI00056, FBI00062, FBI00078,FBI00096, FBI00104, FBI00110, FBI00111, FBI00113, FBI00115, FBI00116,FBI00123, FBI00124, FBI00126, FBI00135, FBI00147, FBI00159, FBI00167,FBI00170, FBI00232, FBI00255, FBI00271, FBI00022, FBI00049, FBI00068,FBI00069, FBI00152, FBI00165, FBI00171, FBI00175, FBI00177, FBI00180,FBI00182, FBI00238, FBI00269, FBI00274, and FBI00281, or a functional equivalent thereof; h) FBI00001, FBI00002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033,FBI00034, FBI00043, FBI00044, FBI00048, FBI00050, FBI00051, FBI00057,FBI00059, FBI00060, FBI00070, FBI00071, FBI00076, FBI00079, FBI00087,FBI00093, FBI00102, FBI00109, FBI00117, FBI00120, FBI00125, FBI00127,FBI00128, FBI00145, FBI00162, FBI00174, FBI00184, FBI00190, FBI00191,FBI00194, FBI00198, FBI00199, FBI00200, FBI00201, FBI00205, FBI00206,FBI00211, FBI00220, FBI00221, FBI00236, FBI00245, FBI00248, FBI00251,FBI00254, FBI00267, FBI00278, FBI00288, and FBI00290 or a functional equivalent thereof;ACTIVE 511662979.2 94PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT i) FBI00004, FBI00012, FBI00015, FBI00018, FBI00019, FBI00021, FBI00038,FBI00040, FBI00046, FBI00061, FBI00066, FBI00075, FBI00077, FBI00080,FBI00081, FBI00085, FBI00092, FBI00097, FBI00099, FBI00112, FBI00132,FBI00137, FBI00140, FBI00149, FBI00151, FBI00176, FBI00189, FBI00197,FBI00208, FBI00212, FBI00224, FBI00226, FBI00229, FBI00233, FBI00235,FBI00237, FBI00243, FBI00244, FBI00258, FBI00260, FBI00263, FBI00270,FBI00273, FB 100277, and FBI00292, or a functional equivalent thereof; j) FBI00009, FBI00011, FBI00016, FBI00020, FBI00025, FBI00027, FBI00030,FBI00047, FBI00052, FBI00053, FBI00056, FBI00062, FBI00078, FBI00096,FBI00104, FBI00110, FBI00111, FBI00113, FBI00115, FBI00116, FBI00123,FBI00124, FBI00126, FBI00135, FBI00147, FBI00159, FBI00167, FBI00170,FBI00232, FBI00255, and FBI00271, or a functional equivalent thereof; or k) FBI00022, FBI00049, FBI00068, FBI00069, FBI00152, FBI00165, FBI00171, FBI00175, FBI00177, FBI00180, FBI00182, FBI00238, FBI00269, FBI00274, and FBI00281, or a functional equivalent thereof.

26. The method of claim 25, wherein the microbial consortium comprises the plurality of microbes set forth in Figures 5A-5C.

27. The method of claim 25, wherein the microbial consortium consists of the plurality of microbes set forth in Figures 5A-5C.

28. The method of claim 25, wherein the microbial consortium comprises the plurality of microbes comprising strains of the microbes set forth in Figure 11.

29. The method of claim 25, wherein the microbial consortium consists of the plurality of microbes consisting of strains of the microbes set forth in Figure 11.

30. The method of any one of claims 25-29, wherein the immune-related adverse event is a gastrointestinal toxicity, a dermatologic toxicity, a hepatotoxicity, an endocrinopathy, pneumonitis, arthralgia, arthritis, nephritis, a cardiotoxicity, neurological toxicity, or a hematologic toxicity, or combinations thereof.

31. The method of any one of claims 25-29, wherein the phenotype associated with the immune- related adverse event is impaired intestinal barrier integrity.

32. The method of any one of claims 25-29, wherein the phenotype associated with the immune- related adverse event is due to altered absolute abundance levels of short chain fatty acids (SCFAs) or altered relative abundance levels of SCFAs.

33. The method of any one of claims 25-29, wherein the phenotype associated with the immune- related adverse event is due to altered absolute abundance levels of conjugated bile acids,ACTIVE 511662979.2 95PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENT primary bile acids, secondary bile acids or altered relative abundance levels of the bile acid pool.

34. The method of any one of claims 25-29, wherein the immune-related adverse event is colitis.

35. The method of claim 34, wherein the phenotype associated with colitis is abdominal pain, bloated stomach, diarrhea, blood in the stool, loss of appetite, weight loss, vomiting, or fever.

36. The method of any one of claims 25-29, wherein: a) the phenotype associated with the dermatologic toxicity is a rash, pruritus, or vitiligo; b) the phenotype associated with the hepatotoxicity is hepatitis; c) the phenotype associated with the endocrinopathy is an inflammation of an endocrine gland; d) the phenotype associated with the pneumonitis is cough, shortness of breath or chest pain; e) the phenotype associated with the arthralgia or arthritis is joint pain or inflammation mimicking autoimmune arthritis; f) the phenotype associated with the cardiotoxicity is inflammation of the heart muscle, inflammation of the lining around the heart, myocarditis, or pericarditis; g) the phenotype associated with the neurological toxicity is peripheral neuropathy, nerve damage, myasthenia gravis, or neuromuscular disorder; and h) the phenotype associated with the hematologic toxicity is immune thrombocytopenia or hemolytic anemia.

37. The method of any one of claims 25-36, wherein the immunotherapy comprises an immune checkpoint inhibitor (ICI).

38. The method of claim 37, wherein the ICI comprises an anti-PDl antibody, an anti-PD-Ll antibody, an anti-CTLA-4 antibody, an anti-BTLA antibody, an anti-TIM3 antibody, an anti- LAG-3 antibody, or a combination thereof.

39. The method of claim 38, wherein the ICI comprises an anti-PDl antibody and an anti-CTLA- 4 antibody.

40. The method of claim 38, wherein the anti-PDl antibody comprises pembrolizumab, nivolumab, cemiplimab, dostarlimab, retifanlimab-dlwr, tislelizumab, or combinations thereof.

41. The method of claim 38, wherein the anti-PD-Ll antibody comprises atezolizumab, avelumab, durvalumab, or a combination thereof.

42. The method of claim 38, wherein the anti-CTLA4 antibody comprises ipilimumab or tremelimumab, or a combination thereof.ACTIVE 511662979.2 96PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT43. The method of any one of claims 25-42, wherein the microbial consortium or a pharmaceutical composition thereof comprises between about 1 x 107and about 1 x 1013viable cells, between about 1 x io8and about 1 x 1013viable cells, between about 1 x io9and about 1 x io13viable cells, between about 1 x 1O10and about 1 x 1013viable cells, between about 1 x 1011and about 1 x io13viable cells, between about 1 x io12and about 1 x io13viable cells, between about 1 x 107and about 1 x io12viable cells, between about 1 x io7and about 1 x io11viable cells, between about 1 x io7and about 1 x io10viable cells, between about 1 x io7and about 1 x 109viable cells, between about 1 x io7and about 1 x io8viable cells, between about 1 x io8and about 1 x io9viable cells, between about 1 x io9and about 1 x io10viable cells, between about 1 x io11and about 1 x io12viable cells, between about 1 x io12and about 1 x io13viable cells, between about 5 x io9and about 5 x io10viable cells, between about 5 x io10and about 5 x io11viable cells, or between about 5 x io11and about 5 x io12viable cells.

44. The method of any one of claims 25-42, wherein the microbial consortium or a pharmaceutical composition thereof comprises up to about 1011viable cells or up to about 1012viable cells.

45. The method of any one of claims 25-44, wherein the method comprises administering a loading dose and one or more maintenance doses of the microbial consortium or a pharmaceutical composition thereof.

46. The method of claim 45, wherein the loading dose is administered for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days after the immunotherapy.

47. The method of claim 45, wherein the loading dose is administered 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10, hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 2 months, 3 months, 4 months, 5 months, 6 months or longer after the onset of one or more phenotypes associated with an immune-related adverse event.

48. The method of claim 45, wherein the loading dose is administered daily for the duration of the ICI therapy administered to the patient.

49. The method of any one of claims 45-48, wherein the maintenance doses are administered for at least 21 days, at least 1 month, at least 2 months, at least 4 months, at least 6 months, at least 8 months, at least 10 months, at least 12 months, at least 18 months, or at least 24 months following the last loading dose.

50. The method of claim 45, wherein the loading dose comprises about 1012viable cells.

51. The method of claim 50, wherein the loading dose comprises one or more coated enteric capsules.ACTIVE 511662979.2 97PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT52. The method of claim 51, wherein the one or more coated enteric capsules comprise about 1011viable cells.

53. The method of claim 51 or 52, wherein the loading dose comprises 10 coated enteric capsules.

54. The method of any one of claims 50-53, wherein the loading dose is administered for 1 day.

55. The method of any one of claims 50-54, wherein the loading dose is administered twice a day.

56. The method of any one of claims 50-55, wherein the maintenance dose comprises about 2 x 1011viable cells.

57. The method of claim 56, wherein each maintenance dose comprises one or more coated enteric capsules.

58. The method of claim 57, wherein the one or more coated enteric capsules comprise about 1011viable cells.

59. The method of claim 57 or 58, wherein each maintenance dose comprises 2 coated enteric capsules.

60. The method of any one of claims 50-59, wherein the maintenance doses are administered for 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 10 weeks, or 12 weeks following the last loading dose.

61. The method of any one of claims 25-60, wherein the microbial consortium or pharmaceutical composition thereof is present in a food product, a probiotic, a prebiotic, or a combination thereof.

62. The method of any one of claims 25-61, wherein the microbial consortium or pharmaceutical composition is administered orally or rectally.

63. The method of claim 62, wherein the microbial consortium or pharmaceutical composition is administered via colonoscope.

64. A method for preventing one or more phenotypes associated with an immune-related adverse event, the method comprising administering an effective amount of a microbial consortium or a pharmaceutical composition thereof comprising: a) Clostridium citroniae, Bacteroides salyersiae, Blautia obeum, Parabacteroides merdae, Parabacteroides distasonis, Anaerostipes hadrus, Lachnospiraceae sp. FBI00033 (also known as Lacrimispora amygdalina , Eubacterium eligens, Bifidobacterium dentium, Blautia wexlerae, Fusicatenibacter saccharivorans, Bacteroides nordii, Dorea formicigenerans, Dorea longicatena, Bacteroides stercorirosoris (also known as Bacteroides oleiciplenus), Bifidobacterium longum, Bacteroides kribbi (also known as Bacteroides koreensis), Lachnospiraceae sp. FBI00071 (also known as Roseburia faecis), Bacteroides thetaiotaomicron,ACTIVE 511662979.2 98PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also known as Clostridium symbiosum), Coprococcus comes, Blautia faecis, Hungatella hathewayi, Bacteroides stercoris, Collinsella aerofaciens, Hungatella effluvii, Bifidobacterium adolescentis, Bifidobacterium catenulatum, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Bacteroides faecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as Clostridium prolinivorans), Ruminococcus faecis, Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, Butyricimonas faecihominis, Eisenbergiella tayi, Acidaminococcus intestini, Emergencia timonensis, Bifidobacterium pseudocatenulatum, Eubacterium hallii (also known as Anaerobutyricum hallii), Anaerofustis stercorihominis, Eubacterium ventriosum, Blautia hydrogenotrophica, Lachnospiraceae sp. FBI00290 (also known as Eubacterium ruminantium), Acutalibacter timonensis (also known as Neglecta timonensis), Alistipes onderdonkii, Bacteroides uniformis, Eubacterium rectale (also known as Agathobacter rectalis), Alistipes timonensis, Bacteroides kribbi, Coprococcus eutactus, Bilophila wadsworthia, Bacteroides caccae, Alistipes shahii, Parasutterella excrementihominis, Paraprevotella clara, Sutterella wadsworthensis, Sutterella massiliensis, Porphyromonas asaccharolytica, Ruminococcus bromii, Monoglobus pectinilyticus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter pamelaeae, Bacteroides uniformis, Gordonibacter pamelaeae, Bacteroides fragilis, Phascolarctobacterium faecium, Monoglobus pectinilyticus, Clostridium aldenense, Ruthenibacterium lactatiformans, Bacteroides ovatus (also known as Bacteroides koreensis), Bifidobacterium bifidum, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutterella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis), Alistipes senegalensis, Ruminococcaceae sp. FBI00233 (also known as Anaerotruncus colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum, Faecalibacterium prausnitzii, Turicibacter sanguinis, Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, Methanobrevibacter smithii, Bifidobacterium adolescentis (also known as Bifidobacterium faecale), Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes,Fusicatenibacter saccharivorans, Eggerthella lenta, Eubacterium eligens,ACTIVE 511662979.2 99PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Bacteroides xylanisolvens, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Clostridium citroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenta, Blautia wexlerae (also known as Blautia luti), Lachnoclostridium pacaense, Bacteroides vulgatus, Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis, Anaerostipes hadrus, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolteae, Eisenbergiella tayi, Dorea longicatena, Eggerthella lenta, Bacteroides stercoris, Hungatella hathewayi, Bacteroides xylanisolvens, Alistipes putredinis, Dialister succinatiphilus, Akkermansia muciniphila, Ruminococcus bromii, Dialister invisus, Bacteroides massiliensis, Bilophila wadsworthia, Holdemanella biformis, Parasutterella excrementihominis, Alistipes sp. FBI00180 (also known as Alistipes senegalensis), Bacteroides coprocola, Alistipes sp. FBI00238 (also known as Alistipes finegoldii), Alistipes putredinis, Eubacterium xylanophilum, and Senegalimassilia anaerobia, or a functional equivalent thereof; b) Clostridium citroniae, Bacteroides salyersiae, Blautia obeum, Parabacteroides merdae, Parabacteroides distasonis, Anaerostipes hadrus, Lachnospiraceae sp. FBI00033 (also known as Lacrimispora amygdalina), Eubacterium eligens, Bifidobacterium dentium, Blautia wexlerae, Fusicatenibacter saccharivorans, Bacteroides nordii, Dorea formicigenerans, Dorea longicatena, Bacteroides stercorirosoris (also known as Bacteroides oleiciplenus), Bifidobacterium longum, Bacteroides kribbi (also known as Bacteroides koreensis), Lachnospiraceae sp. FBI00071 (also known as Roseburia faecis), Bacteroides thetaiotaomicron, Clostridium clostridioforme, Clostridium scindens, Roseburia hominis, Clostridium fessum (also known as Clostridium symbiosum), Coprococcus comes, Blautia faecis, Hungatella hathewayi, Bacteroides stercoris, Collinsella aerofaciens, Hungatella effluvia (also known as Hungatella effiuvii), Bifidobacterium adolescentis, Bifidobacterium catenulatum, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Bacteroides faecis, Bacteroides finegoldii, Clostridiaceae sp. FBI00191 (also known as Clostridium prolinivorans), Ruminococcus faecis, Lachnoclostridium pacaense, Clostridium bolteae, Longicatena caecimuris, Eggerthella lenta, Blautia massiliensis (also known as Blautia luti), Bacteroides xylanisolvens, Bacteroides vulgatus, Megasphaera massiliensis, Butyricimonas faecihominis, Eisenbergiella tayi, Acidaminococcus intestini, Emergencia timonensis, Bifidobacterium pseudocatenulatum, Eubacterium hallii (also known as Anaerobutyricum hallii), Anaerofustis stercorihominis, Eubacterium ventriosum,ACTIVE 511662979.2 100PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT Blautia hydrogenotrophica, and Lachnospiraceae sp. FBI00290 (also known asEubacterium ruminantium), or a functional equivalent thereof; c) Acutalibacter timonensis (also known as Neglecta timonensis), Alistipes onderdonkii, Bacteroides uniformis, Eubacterium rectale (also known as Agathobacter reclalis). Alistipes timonensis, Bacteroides kribbi, Coprococcus eulaclus. Bilophila wadsworthia, Bacteroides caccae, Alistipes shahii, Parasutterella excremenlihominis, Paraprevotella clara, Sutterella wadsworthensis, Sutterella massiliensis, Porphyromonas asaccharolylica, Ruminococcus bromii, Monoglobus pectinilyticus, Ruminococcaceae sp. FBI00097 (also known as Merdimmobilis hominis), Gordonibacter pamelaeae, Bacteroides iiniformis, Gordonibacter pamelaeae, Bacteroides fragilis, Phascolarctobacterium faecium. Monoglobus pectinilyticus, Clostridium aldenense, Ruthenibacterium lactatif ormans, Bacteroides ovatus (also known as Bacteroides koreensis), Bifidobacterium bifidiim, Anaerotruncus massiliensis (also known as Anaerotruncus colihominis), Clostridium aldenense, Sutterella wadsworthensis, Catabacter hongkongensis (also known as Christensenella hongkongensis), Alistipes senegalensis, Ruminococcaceae sp. FBI00233 (also known as Anaerotruncus colihominis), Alistipes shahii, Dielma fastidiosa, Eubacterium siraeum, Faecalibacterium prausnitzii, Turicibacter sanguinis, Eubacterium rectale (also known as Agathobacter rectalis), Bacteroides caccae, Methanobrevibacter smithii, Barnesiella intestinihominis, Alistipes onderdonkii, and Methanobrevibacter smithii or a functional equivalent thereof; d) Bifidobacterium adolescentis (also known as Bifidobacterium faecale), Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bacteroides thetaiotaomicron, Coprococcus comes, Fusicatenibacter saccharivorans, Eggerthella lenta, Eubacterium eligens, Bacteroides xylanisolvens, Lactobacillus rogosae (also known as Lachnospira pectinoschiza), Clostridium citroniae, Collinsella aerofaciens, Blautia obeum, Eggerthella lenta, Blautia wexlerae (also known as Blautia luti), Lachnoclostridium pacaense, Bacteroides vulgatus, Parabacteroides merdae, Dorea formicigenerans, Ruminococcus faecis, Roseburia hominis, Anaerostipes hadrus, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Clostridium bolteae, Eisenbergiella tayi, Dorea longicatena, Eggerthella lenta, Bacteroides stercoris, Hungatella hathewayi, and Bacteroides xylanisolvens or a functional equivalent thereof; e) Alistipes putredinis, Dialister succinatiphilus, Akkermansia muciniphila, Ruminococcus bromii, Dialister invisus, Bacteroides massiliensis, BilophilaACTIVE 511662979.2 101PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT wadsworthia, Holdemanella biformis, Parasutterella excremenlihominis. Alistipes sp. FBI00180 (also known as Alistipes senegalensis). Bacteroides coprocola, Alistipes sp. FBI00238 (also known as Alistipes finegoldii), Alistipes pulredinis, Eubacterium xylanophiliim. and Senegalimassilia anaerobia or a functional equivalent thereof; f) Bifidobacterium adolescentis, Bifidobacterium bifidum, Bifidobacterium calenulalum. Bifidobacterium denlium. Bifidobacterium faecale. Bifidobacterium longum. Bifidobacterium pseudocatenulatum, Collinsella aerofaciens. Eggerthella lenla, Gordonibacter pamelaeae, Senegalimassilia anaerobia, Alistipes finegoldii, Alistipes onderdonkii, Alistipes pulredinis, Alistipes senegalensis, Alistipes shahii, Alistipes timonensis, Bacteroides caccae, Bacteroides coprocola, Bacteroides faecis, Bacteroides finegoldii, Bacteroides fragilis, Bacteroides koreensis, Bacteroides kribbi, Bacteroides massiliensis, Bacteroides nordii, Bacteroides oleiciplenus, Bacteroides salyersiae, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides xylanisolvens, Barnesiella intestinihominis, Butyricimonas faecihominis, Parabacteroides distasonis, Parabacteroides merdae, Paraprevotella clara, Phocaeicola vulgatus, Porphyromonas asaccharolytica, Methanobrevibacter smithii, Acidaminococcus intestini, Agathobacter rectalis, Anaerobutyricum hallii, Anaerofustis stercorihominis, Anaerostipes hadrus, Anaerotruncus colihominis, Blautia faecis, Blautia hydrogenotrophica, Blautia luti, Blautia obeum, Blautia wexlerae, Christensenella hongkongensis, Clostridium aldenense, Clostridium bolteae, Clostridium citroniae, Clostridium clostridioforme, Clostridium prolinivorans, Clostridium scindens, Clostridium symbiosum, Coprococcus comes, Coprococcus eutactus, Dialister invisus, Dialister succinatiphilus, Dielma fastidiosa, Dorea formicigenerans, Dorea longicatena, Eisenbergiella tayi, Emergencia timonensis, Eubacterium eligens, Eubacterium ruminantium, Eubacterium siraeum, Eubacterium ventriosum, Eubacterium xylanophilum, Faecalibacterium prausnitzii, Fusicatenibacter saccharivorans, Holdemanella biformis, Hungatella effluvii, Hungatella hathewayi, Lachnoclostridium pacaense, Lachnospira pectinoschiza, Lacrimispora amygdalina, Longicatena caecimuris, Megasphaera massiliensis, Merdimmobilis hominis, Monoglobus pectinilyticus, Neglecta timonensis, Phascolarctobacterium faecium, Roseburia faecis, Roseburia hominis, Ruminococcus bromii, Ruminococcus faecis, Ruthenibacterium lactatif ormans, Turicibacter sanguinis, Parasutterella excrementihominis, Sutterella massiliensis, Sutterella wadsworthensis, Bilophila wadsworthia, Akkermansia muciniphila, or a functional equivalent thereof;ACTIVE 511662979.2 102PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT g) FBI00001, FBI00002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033,FBI00034, FBI00043, FBI00044, FBI00048, FBI00050, FBI00051, FBI00057,FBI00059, FBI00060, FBI00070, FBI00071, FBI00076, FBI00079, FBI00087,FBI00093, FBI00102, FBI00109, FBI00117, FBI00120, FBI00125, FBI00127,FBI00128, FBI00145, FBI00162, FBI00174, FBI00184, FBI00190, FBI00191,FBI00194, FBI00198, FBI00199, FBI00200, FBI00201, FBI00205, FBI00206,FBI00211, FBI00220, FBI00221, FBI00236, FBI00245, FBI00248, FBI00251,FBI00254, FBI00267, FBI00278, FBI00288, FBI00290, FBI00004, FBI00012,FBI00015, FBI00018, FBI00019, FBI00021, FBI00038, FBI00040, FBI00046,FBI00061, FBI00066, FBI00075, FBI00077, FBI00080, FBI00081, FBI00085,FBI00092, FBI00097, FBI00099, FBI00112, FBI00132, FBI00137, FBI00140,FBI00149, FBI00151, FBI00176, FBI00189, FBI00197, FBI00208, FBI00212,FBI00224, FBI00226, FBI00229, FBI00233, FBI00235, FBI00237, FBI00243,FBI00244, FBI00258, FBI00260, FBI00263, FBI00270, FBI00273, FBI00277,FBI00292, FBI00009, FBI00011, FBI00016, FBI00020, FBI00025, FBI00027,FBI00030, FBI00047, FBI00052, FBI00053, FBI00056, FBI00062, FBI00078,FBI00096, FBI00104, FBI00110, FBI00111, FBI00113, FBI00115, FBI00116,FBI00123, FBI00124, FBI00126, FBI00135, FBI00147, FBI00159, FBI00167,FBI00170, FBI00232, FBI00255, FBI00271, FBI00022, FBI00049, FBI00068,FBI00069, FBI00152, FBI00165, FBI00171, FBI00175, FBI00177, FBI00180,FBI00182, FBI00238, FBI00269, FBI00274, and FBI00281, or a functional equivalent thereof; h) FBI00001, FBI00002, FBI00010, FBI00013, FBI00029, FBI00032, FBI00033,FBI00034, FBI00043, FBI00044, FBI00048, FBI00050, FBI00051, FBI00057,FBI00059, FBI00060, FBI00070, FBI00071, FBI00076, FBI00079, FBI00087,FBI00093, FBI00102, FBI00109, FBI00117, FBI00120, FBI00125, FBI00127,FBI00128, FBI00145, FBI00162, FBI00174, FBI00184, FBI00190, FBI00191,FBI00194, FBI00198, FBI00199, FBI00200, FBI00201, FBI00205, FBI00206,FBI00211, FBI00220, FBI00221, FBI00236, FBI00245, FBI00248, FBI00251,FBI00254, FBI00267, FBI00278, FBI00288, and FBI00290 or a functional equivalent thereof; i) FBI00004, FBI00012, FBI00015, FBI00018, FBI00019, FBI00021, FBI00038,FBI00040, FBI00046, FBI00061, FBI00066, FBI00075, FBI00077, FBI00080,FBI00081, FBI00085, FBI00092, FBI00097, FBI00099, FBI00112, FBI00132,FBI00137, FBI00140, FBI00149, FBI00151, FBI00176, FBI00189, FBI00197,ACTIVE 511662979.2 103PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENTFBI00208, FBI00212, FBI00224, FBI00226, FBI00229, FBI00233, FBI00235,FBI00237, FBI00243, FBI00244, FBI00258, FBI00260, FBI00263, FBI00270,FBI00273, FB 100277, and FBI00292, or a functional equivalent thereof; j) FBI00009, FBI00011, FBI00016, FBI00020, FBI00025, FBI00027, FBI00030,FBI00047, FBI00052, FBI00053, FBI00056, FBI00062, FBI00078, FBI00096,FBI00104, FBI00110, FBI00111, FBI00113, FBI00115, FBI00116, FBI00123,FBI00124, FBI00126, FBI00135, FBI00147, FBI00159, FBI00167, FBI00170,FBI00232, FBI00255, and FBI00271, or a functional equivalent thereof; or k) FBI00022, FBI00049, FBI00068, FBI00069, FBI00152, FBI00165, FBI00171, FBI00175, FBI00177, FBI00180, FBI00182, FBI00238, FBI00269, FBI00274, and FBI00281, or a functional equivalent thereof.

65. The method of claim 64, wherein the microbial consortium comprises the plurality of microbes set forth in Figures 5A-5C.

66. The method of claim 64, wherein the microbial consortium consists of the plurality of microbes set forth in Figures 5A-5C.

67. The method of claim 64, wherein the microbial consortium comprises the plurality of microbes comprising strains of the microbes set forth in Figure 11.

68. The method of claim 64, wherein the microbial consortium consists of the plurality of microbes consisting of strains of the microbes set forth in Figure 11.

69. The method of any one of claims 64-68, wherein the immune-related adverse event is a gastrointestinal toxicity, a dermatologic toxicity, a hepatotoxicity, an endocrinopathy, pneumonitis, arthralgia, arthritis, nephritis, a cardiotoxicity, neurological toxicity, or a hematologic toxicity, or combinations thereof.

70. The method of any one of claims 64-68, wherein the phenotype associated with the immune- related adverse event is impaired intestinal barrier integrity.

71. The method of any one of claims 64-68, wherein the phenotype associated with the immune- related adverse event is due to altered absolute abundance levels of short chain fatty acids (SCFAs) or altered relative abundance levels of SCFAs.

72. The method of any one of claims 64-68, wherein the phenotype associated with the immune- related adverse event is due to altered absolute abundance levels of conjugated bile acids, primary bile acids, secondary bile acids or altered relative abundance levels of the bile acid pool.

73. The method of any of claims 64-68, wherein the immune-related adverse event is colitis.

74. The method of claim 73, wherein the phenotype associated with colitis is abdominal pain, bloated stomach, diarrhea, blood in the stool, loss of appetite, weight loss, vomiting, or fever.ACTIVE 511662979.2 104PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123PATENT75. The method of any of claims 64-68, wherein a) the phenotype associated with the dermatologic toxicity is a rash, pruritus, or vitiligo; b) the phenotype associated with the hepatotoxicity is hepatitis; c) the phenotype associated with the endocrinopathy is an inflammation of an endocrine gland; d) the phenotype associated with the pneumonitis is cough, shortness of breath or chest pain; e) the phenotype associated with the arthralgia or arthritis is joint pain or inflammation mimicking autoimmune arthritis; f) the phenotype associated with the cardiotoxicity is inflammation of the heart muscle (e.g., myocarditis) or the lining around the heart (e.g., pericarditis); g) the phenotype associated with the neurological toxicity is peripheral neuropathy, nerve damage, myasthenia gravis, or neuromuscular disorder; and h) the phenotype associated with the hematologic toxicity is immune thrombocytopenia or hemolytic anemia.

76. The method of any of claims 64-75, wherein the immunotherapy comprises an immune checkpoint inhibitor (ICI).

77. The method of claim 76, wherein the ICI comprises an anti-PDl antibody, an anti-PD-Ll antibody, an anti-CTLA-4 antibody, an anti-BTLA antibody, an anti-TIM3 antibody, an anti- LAG-3 antibody, or a combination thereof.

78. The method of claim 77, wherein the ICI comprises an anti-PDl antibody and an anti-CTLA- 4 antibody.

79. The method of claim 77, wherein the anti-PDl antibody comprises pembrolizumab, nivolumab, cemiplimab, dostarlimab, retifanlimab-dlwr, and tislelizumab, or combinations thereof.

80. The method of claim 77, wherein the anti-PD-Ll antibody comprises atezolizumab, avelumab, durvalumab, or a combination thereof.

81. The method of claim 77, wherein the anti-CTL4 antibody comprises ipilimumab or tremelimumab, or a combination thereof.

82. The method of any one of claims 64-81, wherein the microbial consortium or a pharmaceutical composition thereof comprises between about 1 x 107and about 1 x 1013viable cells, between about 1 x 108and about 1 x 1013viable cells, between about 1 x io9and about 1 x io13viable cells, between about 1 x 1O10and about 1 x 1013viable cells, between about 1 x 1011and about 1 x io13viable cells, between about 1 x io12and about 1 x io13viable cells, between about 1 x 107and about 1 x 1Q12viable cells, between about 1 x 1Q7and about 1 x 1Q11viable cells,ACTIVE 511662979.2 105PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT between about 1 x 107and about 1 x IO10viable cells, between about 1 x io7and about 1 x 109viable cells, between about 1 x io7and about 1 x 108viable cells, between about 1 x io8and about 1 x io9viable cells, between about 1 x io9and about 1 x io10viable cells, between about 1 x io11and about 1 x io12viable cells, between about 1 x io12and about 1 x io13viable cells, between about 5 x io9and about 5 x io10viable cells, between about 5 x io10and about 5 x io11viable cells, or between about 5 x io11and about 5 x io12viable cells.

83. The method of any one of claims 64-81, wherein the microbial consortium or a pharmaceutical composition thereof comprises up to about 1011viable cells or up to about 1012viable cells.

84. The method of any one of claims 64-83, wherein the method comprises administering a loading dose and one or more maintenance doses of the microbial consortium or a pharmaceutical composition thereof.

85. The method of claim 84, wherein the loading dose is administered before, after, or at the same time as the immunotherapy.

86. The method of claim 84, wherein the loading dose is administered 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days before the immunotherapy.

87. The method of claim 84, wherein the loading dose is administered 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days after the immunotherapy.

88. The method of claim 84, wherein the loading dose is administered at the same time as the immunotherapy.

89. The method of claim 84, wherein the loading dose is administered for 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, or 10 days.

90. The method of claim 84, wherein the loading dose is administered for 2-3 days, 3-5 days, 4-6 days, or 5-7 days.

91. The method of any one of claims 84-90, wherein the one or more maintenance doses are administered for at least 21 days, at least 1 month, at least 2 months, at least 4 months, at least 6 months, at least 8 months, at least 10 months, at least 12 months, at least 18 months, or at least 24 months following the last loading dose.

92. The method of claim 84, wherein the loading dose comprises about 1012viable cells.

93. The method of claim 92, wherein the loading dose comprises one or more coated enteric capsules.

94. The method of claim 93, wherein the one or more coated enteric capsules comprise about 1011viable cells.

95. The method of claim 93 or 94, wherein the loading dose comprises 10 coated enteric capsules.

96. The method of any one of claims 92-95, wherein the loading dose is administered for 1 day.

97. The method of any one of claims 92-96, wherein the loading dose is administered twice a day.ACTIVE 511662979.2 106PCT / US25 / 41609 12 August 2025 (12.08.2025)091592.0123 PATENT98. The method of any one of claims 92-97, wherein the maintenance dose comprises about 2 x 1011viable cells.

99. The method of claim 98, wherein each maintenance dose comprises one or more coated enteric capsules.

100. The method of claim 99, wherein the one or more coated enteric capsules comprise about 1011viable cells.

101. The method of claim 99-100, wherein each maintenance dose comprises 2 coated enteric capsules.

102. The method of any one of claims 92-101, wherein the maintenance doses are administered for 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 10 weeks, or 12 weeks following the last loading dose.

103. The method of any one of claims 84-102, wherein the microbial consortium or pharmaceutical composition thereof is present in a food product, a probiotic, a prebiotic, or a combination thereof.

104. The method of any one of claims 84-103, wherein the microbial consortium or pharmaceutical composition is administered orally or rectally.

105. The method of claim 104, wherein the microbial consortium or pharmaceutical composition is administered via colonoscope.ACTIVE 511662979.2 107

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