Compositions comprising bacterial strains

• US 9,839,655 B2
• Filed: 11/21/2016
• Issued: 12/12/2017
• Est. Priority Date: 11/20/2015
• Status: Active Grant

• Current Assignee: CJ Bioscience Incorporated
• Original Assignee: 4D Pharma Research Limited (4D Pharma PLC)
• Inventors: Mulder, Imke Elisabeth, Holt, Amy Beth, Panzica, Domenico, McCluskey, Seanin Marie
• Primary Examiner(s): Baskar, Padmavathi
• Application Number:
  US15/357,850
• Publication Number:
  US 20170143772A1
• Time in Patent Office: 386 Days
• CPC Class Codes: A23C 9/1585 Antibiotics; Bacteriocins; Fungicides from microorganisms
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A61K 2035/11 Medicinal preparations comprising living procariotic cells
• CPC Class Codes: A61K 2039/585 wherein the target is cancer
• CPC Class Codes: A61K 31/739 Lipopolysaccharides
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• CPC Class Codes: A61K 39/09 Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/19 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 Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: C12N 1/20 Bacteria; Culture media therefor
• CPC Class Codes: C12N 1/205 Bacterial isolates
• CPC Class Codes: C12R 2001/46 Streptococcus ; Enterococcus; Lactococcus

Abstract

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

Claims

1. A pharmaceutical composition that comprises:

a therapeutically effective amount of a bacteria strain of the species Enterococcus gallinarum deposited under accession number NCIMB 42488; and

a pharmaceutically acceptable excipient, diluent, or carrier;

wherein said therapeutically effective amount of said bacteria strain is an amount sufficient for treating cancer in a subject, and

wherein said bacteria strain is lyophilized.

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

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

4. 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 said pharmaceutical composition is stored in a closed container at 25°

C. at 95% relative humidity.

5. The pharmaceutical composition of claim 1, wherein said therapeutically effective amount of said bacteria strain comprises from about 1×

10⁶ to about 1×

10¹¹ CFU/g of said bacteria strain with respect to a total weight of said pharmaceutical composition.

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

7. The pharmaceutical composition of claim 1, wherein said 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

.

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

9. The pharmaceutical composition of claim 1, wherein said pharmaceutical composition further comprises 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.

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