IP Library Granted Patent US 11,419,931
Granted Patent B2
US 11,419,931 · App. 17/024,628 · Granted Aug 23, 2022

Compositions comprising bacterial strains

Inventors: Domenico Panzica (Aberdeen, GB); Amy Beth Holt (Aberdeen, GB); Suaad Ahmed (Aberdeen, GB); Anna Ettorre (Aberdeen, GB); Imke Elisabeth Mulder (Aberdeen, GB); Philip Cowie (Aberdeen, GB); Emma Raftis (Aberdeen, GB); Emma Elizabeth Clare Hennessy (Aberdeen, GB); Delphine Louise Claudette Laute-Caly (Aberdeen, GB); Aurélie Pascale Patricia Couturier-Maillard (Aberdeen, GB); Margaret Inkster Delday (Kemnay, GB); Marsilio Adriani (Aberdeen, GB); Maria Christofi (Aberdeen, GB)
Assignee: 4D Pharma Research Limited
A61K39/09A61K35/744A61K2039/585A61P37/04
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Quick Facts
Patent No.
US 11,419,931
App. No.
17/024,628
Granted
Aug 23, 2022
Kind
B2
Abstract

The invention provides compositions comprising bacterial strains for stimulating the immune system and treating and preventing diseases.

Claims (23)

1. A method of increasing differentiation of cytotoxic T cells in a subject in need thereof, comprising

administering to the subject a pharmaceutical composition that comprises a bacteria strain of the genus Enterococcus , wherein the bacteria strain comprises a 16S rRNA gene sequence that has at least 95% sequence identity to the polynucleotide sequence of SEQ ID NO: 2, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12 and a gap extension penalty of 2,

wherein the subject has been diagnosed with deficient immune activity, and

wherein the administering is sufficient to increase differentiation of cytotoxic T cells in the subject, relative to a level of differentiation of cytotoxic T cells in the subject prior to the administering.

2. The method of claim 1 , wherein the cytotoxic T cells are CD8 cells, and wherein the administering is sufficient to increase a level of CD8 cells in a serum of the subject, relative to a level of CD8 cells in the serum of the subject prior to the administering.

3. The method of claim 1 , wherein the administering increases differentiation of T helper cells, relative to a level of differentiation of T helper cells in the subject prior to the administering.

4. The method of claim 1 , wherein the administering activates a toll-like receptor (TLR) signaling pathway in the subject.

5. The method of claim 4 , wherein the TLR is TLR5 or TLR9.

6. The method of claim 1 , wherein the administering increases a level of a cytokine in a serum of the subject, relative to a level of the cytokine in the serum of the subject prior to the administering.

7. The method of claim 6 , wherein the cytokine is IL-6 or IL-23.

8. The method of claim 1 , wherein the administering increases a level of NFκBIA in the subject, relative to a level of NFκBIA in the subject prior to the administering.

9. The method of claim 1 , wherein the administering comprises oral, rectal, nasal, buccal, sublingual, or subcutaneous administration.

10. The method of claim 1 , wherein the bacterial strain is dried.

11. The method of claim 1 , wherein the pharmaceutical composition comprises from about 1×10 3 to about 1×10 11 colony forming units (CFU)/g of the bacteria strain with respect to the total weight of the pharmaceutical composition.

12. The method of claim 1 , wherein the bacteria strain at least partially colonizes an intestine of the subject.

13. The method of claim 1 , wherein the pharmaceutical composition is formulated for delivery to an intestine of the subject.

14. The method of claim 1 , wherein the bacteria strain comprises a 16S rRNA gene sequence that has at least 99% sequence identity to the polynucleotide sequence of SEQ ID NO: 2, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12 and a gap extension penalty of 2.

15. The method of claim 1 , wherein the bacteria strain comprises a 16S rRNA gene sequence that is the polynucleotide sequence of SEQ ID NO: 2 or SEQ ID NO: 3.

16. The method of claim 1 , wherein the bacterial strain is of the species Enterococcus gallinarum.

17. The method of claim 1 , wherein the bacterial strain is the strain deposited under accession number NCIMB 42488 or the strain deposited under accession number NCIMB 42761.

18. The method of claim 1 , wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients, carriers, or diluents.

19. The method of claim 1 , further comprising administering a cell therapy to the subject.

20. The method of claim 19 , the cell therapy is chimeric antigen receptor T cell (CAR-T) therapy, mesenchymal stem cell (MSC) therapy, stem cell transplantation therapy, or hematopoietic stem cell transplantation.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2022
From: OXFORD FINANCE LUXEMBOURG S.A R.L.
To: ARMISTICE CAPITAL MASTER FUND LTD.
Reel/Frame 061806/0371 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 18, 2022
From: PANZICA, DOMENIC; ADRIANI, MARSILIO; LAUTE-CALY, DELPHINE LOUISE CLAUDETTE; CHRISTOFI, MARIA; COWIE, PHILIP; DELDAY, MARGARET INKSTER; ETTORRE, ANNA; CLARE-HENNESSY, EMMA ELIZABETH; HOLT, AMY BETH; COUTURIER-MAILLARD, AURELIE PASCALE PATRICIA; MULDER, IMKE ELISABETH; RAFTIS, EMMA; AHMED, SUAAD
To: 4D PHARMA RESEARCH LIMITED
Reel/Frame 059724/0087 →
INTELECTUAL PROPERTY SECURITY AGREEMENT Recorded Jul 30, 2021
From: 4D PHARMA PLC; 4D PHARMA RESEARCH LIMITED; 4D PHARMA CORK LIMITED; 4D PHARMA DELAWARE INC.
To: OXFORD FINANCE LUXEMBOURG S.A R.L.
Reel/Frame 057042/0715 →
Priority Claims (13)
GB 1804384 · Mar 19, 2018 · national
EP 18178350 · Jun 18, 2018 · regional
GB 1809953 · Jun 18, 2018 · national
GB 1811900 · Jul 20, 2018 · national
GB 1812378 · Jul 30, 2018 · national
GB 1813423 · Aug 17, 2018 · national
GB 1813444 · Aug 17, 2018 · national
GB 1816834 · Oct 16, 2018 · national
GB 1817641 · Oct 29, 2018 · national
GB 1901199 · Jan 29, 2019 · national
GB 1901218 · Jan 29, 2019 · national
GB 1901992 · Feb 13, 2019 · national
GB 1901993 · Feb 13, 2019 · national
Continuity (2)
Continuation PCTEP2019056894 · Mar 19, 2019
Related Publication 20210169950A1 · Jun 10, 2021