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Title:
NUTRITIVE POLYPEPTIDES AND FORMULATIONS THEREOF, AND METHODS OF PRODUCTION AND USE THEREOF
Document Type and Number:
WIPO Patent Application WO/2015/048333
Kind Code:
A4
Abstract:
Nutritive polypeptides are provided herein. Also provided are various other embodiments including nucleic acids encoding the polypeptides, recombinant microorganisms that make the polypeptides, vectors for expressing the polypeptides, methods of making the polypeptides using recombinant microorganisms, compositions and formulations that comprise the polypeptides, and methods of using the polypeptides, compositions and formulations.

Inventors:
HAMILL MICHAEL J (US)
HEARD KATHRYN (US)
BERRY DAVID A (US)
VON MALTZAHN GEOFFREY (US)
SILVER NATHANIEL W (US)
SAMAYOA PHILLIP (US)
RAHMAN SHAILA (US)
KRAMARCZYK JOHN F (US)
BOGHIGIAN BRETT ADAM (US)
YOUNG DAVID M (US)
BASU SUBHAYU (US)
CHEN YING-JA (US)
DOHERTY MICHAEL (US)
Application Number:
PCT/US2014/057527
Publication Date:
October 15, 2015
Filing Date:
September 25, 2014
Export Citation:
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Assignee:
PRONUTRIA INC (US)
International Classes:
A23L1/305; A23J1/00; A23J1/08; A23L33/00; A61K35/54; A61K38/17; A61K38/38; C07K14/77
Attorney, Agent or Firm:
KABLER, Kevin et al. (Silicon Valley Center801 California Stree, Mountain View CA, US)
Download PDF:
Claims:
AMENDED CLAIMS

received by the International Bureau on 02 Sseptember 2015 (02.09.2015)

CLAIMS

1. A nutritive formulation comprising an isolated enzyme-class polypeptide having

substantially reduced or no substantial primary catalytic activity of a known enzyme, wherein the enzyme-class polypeptide comprises an amino acid sequence at least about 90% identical over at least about 50 amino acids to a polypeptide sequence selected from the group consisting of SEQlD-00001 to SEQID-03909; wherein the enzyme-class polypeptide is present in the formulation at least about 0.5g at a concentration of at least about 10g per kilogram of formulation; wherein the formulation is present as a liquid, semi-liquid or gel in a volume not greater than about 500ml or as a solid or semi-solid in a total mass not greater than about 200g; and wherein the formulation is substantially free of non-comestible products; optionally wherein the enzyme-class polypeptide is formulated in a pharmaceutically acceptable carrier.

2. The formulation of claim 1 , wherein the isolated enzyme-class polypeptide has an

aqueous solubility at pH 7 of at least 12.5 g/L.

3. The formulation of claim 1 or claim 2. wherein the isolated enzyme-class polypeptide has a simulated gastric digestion half-life of less than 30 minutes.

4. The formulation of any of claims 1 to 3, wherein the enzyme-class polypeptide is

substantially thermostable at a pH of at least about 2.

5. The formulation of any preceding claim, further comprising a component selected from a tastant, protein mixture, a polypeptide, a peptide, a free amino acid, a carbohydrate, a lipid, a mineral or mineral source, a vitamin, a supplement, an organism, a

pharmaceutical, and an excipient.

6. The formulation of any preceding claim, wherein the enzyme-class polypeptide is

produced in a genetically modified organism.

7. The formulation of any preceding claim, wherein the enzyme-class polypeptide is produced from a recombinant nucleic acid sequence.

8. The formulation of any preceding claim, substantially free of a surfactant, a polyvinyl alcohol, a propylene glycol, a polyvinyl acetate, a polyvinylpynolidonc, a non-comestible polyacid or polyol other than glycerol or propylene glycol a fatty alcohol, an alkylbenzyl sulfonate, an alkyl glucoside, or a methyl paraben.

9. The formulation of any preceding claim, comprising a plurality of enzyme-class

polypeptides.

10. The formulation of any preceding claim, wherein the enzyme-class polypeptide comprises an amylase, a cellobiohydrolase, a chloroperoxidase, an endoglucanase, a feruloyl- esterase, an alpha-galactosidase, a beta-galactosidase, a glucoamy!ase, a glucose oxidase, a laccase, a lignin-peroxidase, a lipase, a mannanase, a Mn-peroxidase, a phytasc, a methyl esterase, a xylanase or a lysozyme.

1 1. The formulation of claim any preceding claim, wherein the enzyme-class polypeptide is formulated in or as a beverage or a beverage ingredient, or as a food or a food ingredient.

12. A nutritional formulation comprising an isolated nutritive polypeptide comprising an amino acid sequence at least about 90% identical over at least about 50 amino acids to a polypeptide sequence selected from the group consisting of SEQID 00001-03909;

wherein the formulation comprises at least 1.0g of the nutritive polypeptide; wherein the formulation is present as a liquid, semi-liquid or gel in a volume not greater than about 500ml or as a solid or semi-solid in a total mass not greater than about 200g; and wherein the formulation is substantially free of non-comestible products.

13. A nutritional formulation according to any preceding claim or an isolated nutritive polypeptide as defined in any preceding claim for use in a method of preventing or reducing loss of muscle mass and/or muscle function in a human or nun-human mammalian subject, comprising the steps of: i) identifying a human subject at risk of protein malnourishment, and ii) administering to the human subject the nutritional formulation.

14. The nutritional formulation or isolated nutritive polypeptide for use according to claim 13, wherein the human subject is identified as in need of a pharmaceutical composition, wherein administration of the pharmaceutical composition increases a risk of loss of muscle mass and/or muscle function.

15. The nutritional formulation or isolated nutritive polypeptide for use according to claim 13 or 14, wherein the human subject is identified as suffering from a disease, disorder or condition and is in need of a pharmaceutical composition, wherein i) the disease, disorder or condition or ii) the administration of the pharmaceutical composition, or both i) and ii) increases a risk of loss of muscle mass and/or muscle function.

16. A recombinant microorganism comprising a recombinant nucleic acid sequence encoding an enzyme-class polypeptide, wherein the enzyme-class polypeptide is at least 90% identical to a polypeptide selected from the group consisting of SEQlD 00001 -03909.