IP Library Granted Patent US 10,245,287
Granted Patent B2
US 10,245,287 · App. 15/803,721 · Granted Apr 2, 2019

Compositions comprising bacterial strains

Inventors: Imke Elisabeth Mulder (Aberdeen, GB); Amy Beth Holt (Aberdeen, GB); Domenico Panzica (Aberdeen, GB); Seanin Marie McCluskey (Aberdeen, GB)
Assignee: 4D Pharma Research Limited
A61K35/74A23C9/1585A23L33/135A61K9/19A61K31/739A61K35/744A61K39/09A61K45/06C12N1/20C12R1/46A23V2002/00A61K2035/11A61K2039/585
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Quick Facts
Patent No.
US 10,245,287
App. No.
15/803,721
Granted
Apr 2, 2019
Kind
B2
Abstract

The invention provides compositions comprising bacterial strains for treating and preventing cancer.

Claims (26)

1. A pharmaceutical composition that comprises:

a bacteria strain that comprises a 16s rRNA gene sequence with at least 99.5% sequence identity to the polynucleotide of SEQ ID NO:2, wherein the sequence identity is determined by the Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12 and a gap extension penalty of 2, and a BLOSUM matrix of 62; and

a pharmaceutically acceptable excipient, diluent, or carrier;

wherein said bacteria strain has a carbohydrate fermentation profile that comprises:

(i) a positive fermentation of at least one of: L-arabinose and D-xylose; and

(ii) an intermediate fermentation of Methyl-αD-glycopyranoside;

and wherein said bacteria strain is lyophilized.

2. The pharmaceutical composition of claim 1 , wherein said carbohydrate profile further comprises a positive fermentation of at least one of: D-tagatose, D-ribose, potassium gluconate, D-galactose, D-glucose, D-fructose, D-mannose, N-acetylglucosamine, amygdalin, arbutin, salicin, D-cellobiose, D-maltose, sucrose, D-trehalose, and gentiobiose.

3. The pharmaceutical composition of claim 1 , wherein said carbohydrate profile further comprises an intermediate fermentation of at least one of: D-mannitol, D-lactose, and starch.

4. The pharmaceutical composition of claim 1 , wherein said carbohydrate profile further comprises:

i. a positive fermentation of at least one of: D-tagatose, D-ribose, potassium gluconate, D-galactose, D-glucose, D-fructose, D-mannose, N-acetylglucosamine, amygdalin, arbutin, salicin, D-cellobiose, D-maltose, sucrose, D-trehalose, and gentiobiose; and

ii. an intermediate fermentation of at least one of: D-mannitol, D-lactose, and starch.

5. The pharmaceutical composition of claim 4 , wherein said carbohydrate profile comprises a positive fermentation of L-arabinose, D-xylose, and gentiobiose.

6. The pharmaceutical composition of claim 4 , wherein said carbohydrate profile comprises a positive fermentation of L-arabinose and D-xylose and an intermediate fermentation of Methyl-αD-glycopyranoside.

7. The pharmaceutical composition of claim 1 , wherein said acceptable excipient, diluent, or carrier further comprises a lyoprotectant.

8. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition further comprises at least one additional bacteria strain.

9. The pharmaceutical composition of claim 1 , wherein at least 50% of said bacteria strain, as measured by an amount of colony forming units (CFU), remains viable after about 1 year of storage when the pharmaceutical composition is stored in a closed container at 25° C. at 95% relative humidity.

10. The pharmaceutical composition of claim 1 , wherein said bacteria strain is present in an amount that comprises from about 1×10 6 to about 1×10 11 CFU/g of said bacteria strain with respect to a total weight of the pharmaceutical composition.

11. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition further comprises a lipopolysaccharide.

12. The pharmaceutical composition of claim 1 , wherein said bacteria strain is effective to increase production of at least one cytokine selected from the group consisting of IL-6, TNF-α, and IL-1β.

13. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition is formulated for oral delivery.

14. The pharmaceutical composition of claim 13 , wherein said pharmaceutical composition comprises an enteric coating.

15. The pharmaceutical composition of claim 1 , wherein said pharmaceutical composition further comprises an adjuvant.

16. The pharmaceutical composition of claim 1 , wherein said bacteria strain comprises a 16s rRNA gene sequence with at least 99.9% sequence identity to the polynucleotide of SEQ ID NO:2, wherein the sequence identity is determined by the Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12 and a gap extension penalty of 2, and a BLOSUM matrix of 62.

17. The pharmaceutical composition of claim 1 , wherein said bacteria strain comprises the 16s rRNA gene sequence of SEQ ID NO: 2.

18. The pharmaceutical composition of claim 1 , wherein said bacteria strain is of the species Enterococcus gallinarum.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 14, 2023
From: 4D PHARMA PLC; 4D PHARMA RESEARCH LIMITED
To: CJ BIOSCIENCE, INC.
Reel/Frame 063992/0427 →
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 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 8, 2018
From: MULDER, IMKE; HOLT, AMY BETH; PANZICA, DOMENICO; MCCLUSKEY, SEANIN
To: 4D PHARMA RESEARCH LIMITED
Reel/Frame 044861/0721 →
Priority Claims (2)
GB 1520502.4 · Nov 20, 2015 · national
GB 1604924.9 · Mar 23, 2016 · national
Continuity (2)
Continuation 15357850 · Nov 21, 2016
Related Publication 20180078585A1 · Mar 22, 2018