Compositions comprising bacterial strains

Patent metadata

Field	Value
Publication number	US-10357520-B2
Application number	US-201715803721-A
Country	US
Kind code	B2
Filing date	Nov 3, 2017
Priority date	Nov 20, 2015
Publication date	Jul 23, 2019
Grant date	Jul 23, 2019

Abstract

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

First claim

What is claimed is:

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.

Assignees

• 4D Pharma Res Ltd

Inventors

• MULDER Imke Elisabeth
• HOLT Amy Beth
• Panzica Domenico
• Mccluskey Seanin Marie

Classifications

• C12N1/20 Primary

  Bacteria; Culture media therefor · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61K2039/585

  wherein the target is cancer · CPC title

• A61K2035/11

  Medicinal preparations comprising living procariotic cells · CPC title

• A61K39/09

  {Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus}, streptococcus · CPC title