IP Library Granted Patent US 11,701,396
Granted Patent B2
US 11,701,396 · App. 16/702,659 · Granted Jul 18, 2023

Treatment of

Inventors: Jessica Schneider (Cambridge, MA); Yun-Gi Kim (Watertown, MA); Bernat Olle (Cambridge, MA); Shilpa Reddy (Watertown, MA); Jason Norman (North Weymouth, MA); Juan Patarroyo (Lexington, MA)
Assignee: Vedanta Biosciences, Inc.
A61K35/747A23L5/00A23L33/135A61K9/0053A61K9/48A61K35/74A61K35/742A61K38/14C12N1/20A23K10/18A23K50/30A61K9/0031
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Quick Facts
Patent No.
US 11,701,396
App. No.
16/702,659
Granted
Jul 18, 2023
Kind
B2
Abstract

Provided herein are compositions and methods for the treatment or prevention of pathogenic infections.

Claims (30)

1. A pharmaceutical composition comprising a purified bacterial mixture consisting of 7 to 10 bacterial strains, wherein at least 7 of the bacterial strains comprise 16S rDNA sequences of at least 97% sequence identity to sequences independently selected from the group consisting of SEQ ID NO:10, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, SEQ ID NO:19, SEQ ID NO:20, and SEQ ID NO:21; wherein the bacterial strains are lyophilized.

2. The pharmaceutical composition of claim 1 , further comprising a pharmaceutically acceptable excipient.

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

4. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is in the form of a capsule.

5. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for delivery to the colon.

6. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises one or more enteric polymers.

7. A method of treating a Clostridium difficile infection in a subject, the method comprising administering the pharmaceutical composition of claim 1 to the subject in an amount sufficient to treat the Clostridium difficile infection.

8. The method of claim 7 , wherein the Clostridium difficile infection is a first occurrence of the Clostridium difficile infection.

9. The method of claim 7 , wherein the Clostridium difficile infection is a recurrent Clostridium difficile infection.

10. The method of claim 7 , wherein the subject has been treated with an antibiotic prior to recurrence of the Clostridium difficile infection.

11. The method of claim 7 , further comprising administering an antibiotic to the subject.

12. A method to suppress an abnormal or excessive immune response in a subject comprising administering the pharmaceutical composition of claim 1 to the subject in an amount sufficient to suppress the abnormal or excessive immune response.

13. The method of claim 12 , wherein the abnormal or excessive immune response is suppressed by inducing proliferation and/or accumulation of regulatory T cells.

14. The method of claim 12 , wherein the subject is administered one or more doses of an antibiotic prior to the pharmaceutical composition.

15. The method of claim 14 , wherein the antibiotic is vancomycin, kanamycin, gentamicin, colistin, metronidazole, clindamycin, fidaxomicin, or cefoperazone.

16. The method of claim 14 , wherein the antibiotic is vancomycin.

17. A pharmaceutical composition comprising a purified bacterial mixture consisting of 7 to 10 bacterial strains, wherein at least 7 of the bacterial strains comprise 16S rDNA sequences of at least 97% sequence identity to sequences independently selected from the group consisting of SEQ ID NO: 10, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 19, SEQ ID NO:20, and SEQ ID NO:21; and one or more enteric polymers; wherein the pharmaceutical composition comprises between 1×10 7 and 1×10 10 colony forming units (CFUs) per bacterial strain; and wherein the pharmaceutical composition is in the form of a capsule.

18. The pharmaceutical composition of claim 17 , further comprising a pharmaceutically acceptable excipient.

19. The pharmaceutical composition of claim 17 , wherein the pharmaceutical composition is formulated for oral administration.

20. The pharmaceutical composition of claim 17 , wherein the pharmaceutical composition is formulated for delivery to the colon.

21. A method of treating a Clostridium difficile infection in a subject, the method comprising administering the pharmaceutical composition of claim 17 to the subject in an amount sufficient to treat the Clostridium difficile infection.

22. The method of claim 21 , wherein the Clostridium difficile infection is a first occurrence of the Clostridium difficile infection.

23. The method of claim 21 , wherein the Clostridium difficile infection is a recurrent Clostridium difficile infection.

24. The method of claim 21 , wherein the subject has been treated with an antibiotic prior to recurrence of the Clostridium difficile infection.

25. The method of claim 21 , further comprising administering an antibiotic to the subject.

26. A method to suppress an abnormal or excessive immune response in a subject comprising administering the pharmaceutical composition of claim 17 to the subject in an amount sufficient to suppress the abnormal or excessive immune response.

27. The method of claim 26 , wherein the abnormal or excessive immune response is suppressed by inducing proliferation and/or accumulation of regulatory T cells.

28. The method of claim 26 , wherein the subject is administered one or more doses of an antibiotic prior to the pharmaceutical composition.

29. The method of claim 28 , wherein the antibiotic is vancomycin, kanamycin, gentamicin, colistin, metronidazole, clindamycin, fidaxomicin, or cefoperazone.

30. The method of claim 28 , wherein the antibiotic is vancomycin.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Apr 24, 2023
From: OXFORD FINANCE LLC
To: VEDANTA BIOSCIENCES, INC.
Reel/Frame 063440/0569 →
SECURITY INTEREST Recorded Apr 21, 2023
From: VEDANTA BIOSCIENCES, INC.
To: ANKURA TRUST COMPANY, LLC, AS COLLATERAL TRUSTEE
Reel/Frame 063406/0052 →
SECURITY INTEREST Recorded Dec 12, 2022
From: VEDANTA BIOSCIENCES, INC.
To: OXFORD FINANCE LLC
Reel/Frame 062115/0411 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 4, 2020
From: SCHNEIDER, JESSICA; KIM, YUN-GI; OLLE, BERNAT; REDDY, SHILPA; NORMAN, JASON; PATARROYO, JUAN
To: VEDANTA BIOSCIENCES, INC.
Reel/Frame 051798/0123 →
Continuity (7)
Continuation 16423487 · May 28, 2019
Continuation 16157640 · Oct 11, 2018
Continuation 15993037 · May 30, 2018
Continuation 15630088 · Jun 22, 2017
Continuation PCTUS2017037498 · Jun 14, 2017
Provisional Application 62349914 · Jun 14, 2016
Related Publication 20200206284A1 · Jul 2, 2020
Cited By (1)
US 12,390,498