IP Library Granted Patent US 10,610,550
Granted Patent B2
US 10,610,550 · App. 16/251,462 · Granted Apr 7, 2020

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 10,610,550
App. No.
16/251,462
Granted
Apr 7, 2020
Kind
B2
Abstract

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

Claims (23)

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.

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 May 20, 2019
From: MULDER, IMKE ELISABETH; HOLT, AMY BETH; PANZICA, DOMENICO; MCCLUSKEY, SEANIN MARIE
To: 4D PHARMA RESEARCH LIMITED
Reel/Frame 049230/0324 →
Priority Claims (2)
GB 1520502.4 · Nov 20, 2015 · national
GB 1604924.9 · Mar 23, 2016 · national
Continuity (3)
Continuation 15803721 · Nov 3, 2017
Continuation 15357850 · Nov 21, 2016
Related Publication 20190134109A1 · May 9, 2019