Claims for Patent: 10,064,901

Summary for Patent: 10,064,901

Title:	Compositions and methods
Abstract:	Disclosed herein are therapeutic compositions containing non-pathogenic, germination-competent bacterial spores, for the prevention, control, and treatment of gastrointestinal diseases, disorders and conditions and for general nutritional health.
Inventor(s):	McKenzie; Gregory (Arlington, MA), Lombardo McKenzie; Mary-Jane (Arlington, MA), Cook; David N. (Brooklyn, NY), Vulic; Marin (Boston, MA), von Maltzahn; Geoffrey (Boston, MA), Goodman; Brian (Boston, MA), Aunins; John Grant (Doylestown, PA), Henn; Matthew R. (Somerville, MA), Berry; David Arthur (Brookline, MA), Winkler; Jonathan (Boston, MA)
Assignee:	Seres Therapeutics, Inc. (Cambridge, MA)
Application Number:	15/847,623
Patent Claims:	1. A composition for treating or reducing a severity of at least one symptom of a gastrointestinal disease, disorder or condition associated with a dysbiosis in a subject, the composition comprising a purified population of Blautia wexlerae spores in an amount effective to populate a gastrointestinal tract in the subject and a capsule, wherein the Blautia wexlerae spores belong to clade 309 and comprise a 16S sequence that is at least 95% identical to SEQ ID NO: 383; and the composition is derived from a fecal material subjected to ethanol treatment or heat treatment; and the composition is substantially depleted of a residual habitat product of the fecal material; and the Blautia wexlerae spores are not detectable in the fecal material before the ethanol treatment or the heat treatment. 2. The composition of claim 1, wherein the Blautia wexlerae spores comprise a 16S sequence that is at least 97% identical to SEQ ID NO: 383. 3. The composition of claim 1, wherein the Blautia wexlerae spores comprise a 16S sequence that is 100% identical to SEQ ID NO: 383. 4. The composition of claim 1, wherein the composition comprises at least 1.times.10.sup.4 colony forming units of the purified population of Blautia wexlerae spores per dose of the composition. 5. The composition of claim 1, wherein the composition comprises an amount of the purified population of Blautia wexlerae spores effective to augment growth in the subject's gastrointestinal tract of at least one bacteria not detectable in the composition or to modulate microbiota diversity after administration of the composition compared to the microbiota diversity present in the subject's gastrointestinal tract prior to administration of the composition. 6. The composition of claim 1, wherein the subject is a human. 7. The composition of claim 1, wherein the gastrointestinal disease, disorder or condition is selected from the group consisting of Clostridium difficile-induced diarrhea, irritable bowel syndrome (IBS), infection or colonization with a pathogen or pathobiont including a drug resistant pathogen or pathobiont, colitis, a metabolic disorder, and Crohn's disease. 8. The composition of claim 1, wherein the gastrointestinal disease, disorder or condition is Clostridium difficile-induced diarrhea. 9. The composition of claim 1, wherein the fecal material is a 10 to 20% fecal suspension. 10. The composition of claim 1, wherein the fecal material is obtained from a validated mammalian donor subject not having a detectable level of a pathogen or a pathobiont prior to production of the fecal material. 11. The composition of claim 1, wherein the fecal material is obtained from a validated mammalian donor subject not having a detectable level of a blood-borne pathogen or a fecal bacterial pathogen prior to production of the fecal material. 12. The composition of claim 1, wherein the fecal material is obtained from a validated mammalian donor subject not having a detectable level of a pathogen or a pathobiont prior to production of the fecal material and the pathogen or the pathobiont is selected from the group consisting of HIV, HTLV, HCV, HBV, CMV, HAV, Treponema pallidum, Salmonella, Shigella, Yersinia, Campylobacter, E. coli 0157, Giardia, Cryptosporidium Cyclospora, and Isospora. 13. The composition of claim 1, wherein the composition is derived from fecal material subjected to ethanol treatment. 14. The composition of claim 1, wherein the composition is derived from fecal material subjected to treatment with 30-90% ethanol. 15. The composition of claim 1, wherein the composition is derived from fecal material subjected to treatment with 50-70% ethanol. 16. The composition of claim 1, wherein the composition is derived from fecal material subjected to treatment with 50% ethanol. 17. The composition of claim 1, wherein the composition is derived from fecal material subjected to ethanol treatment and the ethanol treatment comprises a. forming a 10% w/v suspension of human fecal material; b. mixing the suspension with absolute ethanol in a 1:1 ratio; c. incubating the suspension of (b); d. collecting the bacterial spores in the suspension; e. adding glycerol to the bacterial spores of (d); and f. storing the composition at -80 degrees Celsius. 18. The composition of claim 1, wherein the composition is derived from fecal material subjected to heat treatment and the heat treatment comprises a. forming a 10% w/v suspension of human fecal material in PBS; b. incubating the suspension of (a) at 80 degrees Celsius for 30 minutes, thereby forming a heat treated suspension; c. adding glycerol to the heat treated suspension; and d. storing the composition at -80 degrees Celsius. 19. The composition of claim 1, wherein the residual habitat product is an abiotic material, a human or animal cell, a virus, a fungus, or a mycoplasma. 20. The composition of claim 1, wherein, using genomic and/or microbiological assay methods, the Blautia wexlerae spores are not detectable in the fecal material before the ethanol treatment or the heat treatment. 21. The composition of claim 1, wherein, using qPCR, the Blautia wexlerae spores are not detectable in the fecal material before the ethanol treatment or the heat treatment. 22. The composition of claim 1, wherein the Blautia wexlerae spores are not detectable in the fecal material before the ethanol treatment or the heat treatment as assayed by full-length 16S sequencing of bacterial colonies grown and isolated from the fecal material before the ethanol or heat treatment. 23. The composition of claim 1, wherein the Blautia wexlerae spores are not detectable in the fecal material before the ethanol treatment or the heat treatment using an assay with a detectable limit of 20 cfu/ml. 24. The composition of claim 1, comprising a delayed release capsule. 25. The composition of claim 1, formulated for oral administration. 26. The composition of claim 1, further comprising an antibiotic. 27. The composition of claim 1, further comprising at least one species of germinable bacterial spores selected from the group consisting of Bacillus licheniformis, Bacillus pumilus, Clostridium hylemonae, Clostridium methypentosum, Clostridium sp YIT 12069, Anaerofustis stercorihominis, Bacillus anthracis, Bacillus horti, Bacillus nealsonii, Bacillus sp. BT1B_CT2, Bacillus thuringiensis, Bacteroides galacturonicus, Bacteroides pectinophilus, Brachyspira pilosicoli, Clostridium aldenense, Clostridium beijerinckii, Clostridium carnis, Clostridium celatum, Clostridium favososporum, Clostridium irregulare, Clostridium sp. L2-50, Clostridium sp. MT4 E, Clostridium sp. NML 04A032, Clostridium sp. SS2/1, Clostridium stercorarium, Clostridium xylanolyticum, Coprococcus sp. ART55/1, Deferribacteres sp. oral clone JV006, Desulfitobacterium frappieri, Eubacterium callanderi, Eubacterium siraeum, Exiguobacterium acetylicum, Gemmiger formicilis, Lachnospira multipara, Lachnospira pectinoschiza, Roseburia faecalis, and Ruminococcus albus.

Details for Patent 10,064,901

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	11/12/1998		2033-02-04