Compositions comprising bacterial strains

Patent metadata

Field	Value
Publication number	US-10610550-B2
Application number	US-201916251462-A
Country	US
Kind code	B2
Filing date	Jan 18, 2019
Priority date	Nov 20, 2015
Publication date	Apr 7, 2020
Grant date	Apr 7, 2020

Abstract

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

First claim

What is claimed is:

1. A pharmaceutical composition comprising:
a therapeutically effective amount of a bacteria strain that comprises a 16s rRNA sequence with at least 95% sequence identity to the polynucleotide of SEQ ID NO: 2;
wherein said therapeutically effective amount of said bacteria strain is an amount sufficient for treating or preventing cancer in a subject, 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
wherein said bacteria strain is lyophilized and/or the pharmaceutical composition further comprises a pharmaceutically acceptable excipient, diluent, or carrier.

2. A pharmaceutical composition comprising:
a therapeutically effective amount of a bacteria strain of the species Enterococcus gallinarum;
wherein said therapeutically effective amount of said bacteria strain is an amount sufficient for treating or preventing cancer in a subject; and
wherein said bacteria strain is lyophilized and/or the pharmaceutical composition further comprises a pharmaceutically acceptable excipient, diluent, or carrier.

3. The pharmaceutical composition of claim 1 , further comprising a lyoprotectant which is a pharmaceutically acceptable excipient, diluent, or carrier.

4. The pharmaceutical composition of claim 1 , comprising a bacteria strain that comprises the 16s rRNA sequence of SEQ ID NO:2.

5. The pharmaceutical composition of claim 1 , comprising a bacteria strain of the species Enterococcus gallinarum.

6. The pharmaceutical composition of claim 1 , said bacteria strain consisting essentially of the species Enterococcus gallinarum.

7. The pharmaceutical composition of claim 1 , further comprising at least one additional bacteria strain.

8. The pharmaceutical composition of claim 1 , wherein at least 50% of the 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.

9. The pharmaceutical composition of claim 1 , wherein the therapeutically effective amount of the bacteria strain 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.

10. The pharmaceutical composition of claim 1 , wherein the composition is a lyophilized composition.

11. The pharmaceutical composition of claim 1 , further comprising a lipopolysaccharide.

12. The pharmaceutical composition of claim 1 , wherein the therapeutically effective amount is an amount 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 the pharmaceutical composition is formulated for oral delivery; and wherein the pharmaceutical composition comprises an enteric coating.

14. The pharmaceutical composition of claim 1 , further comprising a prebiotic compound selected from the group consisting of: a fructo-oligosaccharide, a short-chain fructo-oligosaccharide, inulin, an isomalt-oligosaccharide, a transgalacto-oligosaccharide, a pectin, a xylo-oligosaccharide, a chitosan-oligosaccharide, a beta-glucan, an arable gum modified starch, a polydextrose, a D-tagatose, an acacia fiber, carob, an oat, and a citrus fiber.

15. A vaccine comprising the pharmaceutical composition of claim 1 .

16. A food product that comprises: a therapeutically effective amount of a bacteria strain that comprises a polynucleotide sequence with at least 95% 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 nutritious product.

17. The food product of claim 16 , wherein the nutritious product is a milk-food product, or a milk-based product selected from the group consisting of: a cow's milk, a goat's milk, a sheep's milk, skimmed milk, whole milk, milk recombined from powdered milk, yogurt, curdled milk, curd, sour milk, sour whole milk, butter milk, a whey beverage, a fermented milk, a condensed milk, an infant milk, a flavored milk, and an ice cream.

Assignees

• 4D Pharma Res Ltd

Inventors

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

Classifications

• A61K9/19

  lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)} · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• C12N1/20 Primary

  Bacteria; Culture media therefor · CPC title

• A61K2035/11

  Medicinal preparations comprising living procariotic cells · CPC title

• A61K35/74 Primary

  Bacteria (therapeutic use of a bacterial protein A61K38/00) · CPC title