Pirin polypeptide and immune modulation

• US 10,456,444 B2
• Filed: 06/23/2017
• Issued: 10/29/2019
• Est. Priority Date: 12/23/2014
• Status: Active Grant

• Current Assignee: CJ Bioscience Incorporated
• Original Assignee: 4D Pharma Research Limited (4D Pharma PLC)
• Inventors: Kelly, Denise
• Primary Examiner(s): Devi, Sarvamangala
• Application Number:
  US15/631,952
• Publication Number:
  US 20170326202A1
• Time in Patent Office: 858 Days
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23L 33/17 Amino acids, peptides or proteins
• CPC Class Codes: A23L 33/18 Peptides; Protein hydrolysates
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A61K 2035/115 Probiotics
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 38/164 from bacteria
• CPC Class Codes: A61K 39/0216 Bacteriodetes, e.g. Bacteroides, Ornithobacter, Porphyromonas
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 11/08 Bronchodilators
• CPC Class Codes: A61P 11/14 Antitussive agents
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/04 Antipruritics
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system

Abstract

The present invention relates to polypeptide HP, or a polynucleotide sequence encoding polypeptide HP, or a host cell comprising said polynucleotide sequence, or a host cell comprising an expression vector comprising said polynucleotide sequence, for use in the treatment and/or prevention of a disorder in a subject; wherein said disorder is an inflammatory disorder and/or an autoimmune disorder; wherein said polypeptide has at least 75% identity to SEQ ID NO 2, SEQ ID NO 4 or SEQ ID NO 6 or variants, homologues, fragments or derivatives thereof; and wherein said polynucleotide sequence encodes a polypeptide which has at least 75% identity to SEQ ID NO 2, SEQ ID NO 4 or SEQ ID NO 6 or variants, homologues, fragments or derivatives thereof and/or wherein said polynucleotide sequence has at least 75% identity to SEQ ID NO 1, SEQ ID NO 3 or SEQ ID NO 5 or variants, homologues, fragments or derivatives thereof.

Claims

1. A composition comprising an effective unit dose of an isolated pirin-related polypeptide of Bacteroides thetaiotaomicron, wherein said isolated polypeptide comprises an amino acid sequence having at least 95% sequence identity to the polypeptide sequence of SEQ ID NO:

2 as determined by a sequence alignment performed using a Basic Local Alignment Search Tool algorithm with a gap open penalty of 0, a gap extension penalty of 0, and a Blocks Substitution Matrix of 62, wherein the isolated pirin-related polypeptide is encapsulated as an enterically resistant capsule for delivery to the intestine.

2. The composition of claim 1, wherein said isolated pirin-related polypeptide is SEQ ID NO:

2.

3. The composition of claim 2, wherein said isolated pirin-related polypeptide is Hypothetical Protein (HP).

4. The composition of claim 1, further comprising a preservative or a stabilizer, wherein said preservative or said stabilizer is an antioxidant.

5. The composition of claim 1, further comprising a pharmaceutically acceptable excipient, carrier or diluent.

6. The composition of claim 1, wherein said composition is a solid composition.

7. A composition comprising an effective unit dose of an isolated pirin-related polypeptide of Bacteroides thetaiotaomicron that comprises the amino acid sequence of SEQ ID NO:

2, wherein the isolated pirin-related polypeptide is encapsulated as an enterically resistant capsule for delivery to the intestine.

8. A method of making a composition comprising admixing an effective unit dose of an isolated pirin-related polypeptide of Bacteroides thetaiotaomicron with a preservative or a stabilizer, wherein said isolated polypeptide comprises an amino acid sequence having at least 95% sequence identity to the polypeptide sequence of SEQ ID NO:

2 as determined by a sequence alignment performed using a Basic Local Alignment Search Tool algorithm with a gap open penalty of 0, a gap extension penalty of 0, and a Blocks Substitution Matrix of 62, wherein the isolated pirin-related polypeptide is encapsulated as an enterically resistant capsule for delivery to the intestine.

9. The method of claim 8, wherein said isolated pirin-related polypeptide is SEQ ID NO:

2.