IP Library Granted Patent US 11,357,824
Granted Patent B2
US 11,357,824 · App. 16/819,817 · Granted Jun 14, 2022

Nutritive polypeptides and formulations thereof, and methods of production and use thereof

Inventors: Michael Hamill (Wellesley, MA); Brett Boghigian (Boston, MA); Caitlyn Harvey (Wilmington, MA); David Berry (Brookline, MA); David Young (Portsmouth, NH); Geoffrey Von Maltzahn (Boston, MA); John Kramarczyk (Somerville, MA); Jameson Rogers (Cambridge, MA); Kathryn Heard (Watertown, MA); Michael Doherty (Somerville, MA); Nathaniel Silver (Cambridge, MA); Phillip Samayoa (Cambridge, MA); Subhayu Basu (Chestnut Hill, MA); Shaila Rahman (Cambridge, MA); Vimal Vaidya (Watertown, MA); Ying-Ja Chen (Cambridge, MA)
Assignee: Axcella Health Inc.
A61K38/1709A23L2/66A23L33/17A23L33/175A23L33/18A23L33/195A23L33/30A23L33/40A61K9/0053A61K9/0075A61K9/0095A61K9/146A61K9/2054A61K9/2866A61K38/00A61K38/10A61K38/16A61K38/164A61K38/168A61K38/17A61K38/1703A61K38/1767A61K38/38A61K38/45A61K45/06C12Y207/04003G01N33/6803G01N33/6806G01N33/6848G16B20/00G16B20/50A23V2002/00G01N2500/00
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Quick Facts
Patent No.
US 11,357,824
App. No.
16/819,817
Granted
Jun 14, 2022
Kind
B2
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.

Claims (17)

1. A method of formulating a nutritional product, comprising the steps of providing a nutritive composition comprising an isolated nutritive polypeptide comprising an amino acid sequence corresponding to the polypeptide sequence set forth in SEQ ID NO: 3484; and combining the nutritive composition with an excipient, wherein the excipient is selected from the group consisting of a tastant, a flavorant, a preservative, a stabilizer, a binder, a compaction agent, a lubricant, a dispersion enhancer, a disintegration agent, a flavoring agent, a sweetener, and a coloring agent wherein the excipient is not naturally occurring, thereby formulating a nutritional product, wherein the product comprises at least 0.1 g of the nutritive polypeptide; and wherein the product is present as a liquid, semi-liquid or gel in a volume not greater than about 500 ml or as a solid or semi-solid in a total mass not greater than about 200 g.

2. The method of claim 1 , wherein the product is substantially free of non-comestible products.

3. A nutritive formulation comprising:

(a) an isolated nutritive polypeptide comprising an amino acid sequence corresponding to the polypeptide sequence set forth in SEQ ID NO: 3484;

wherein the formulation comprises at least 1.0 g of the nutritive polypeptide;

wherein the formulation is present as i) a liquid, semi-liquid or gel in a volume not greater than about 500 ml or ii) a solid or semi-solid in a total mass not greater than about 200 g; wherein the formulation is substantially free of non-comestible products; and

(b) an excipient; wherein the excipient is selected from the group consisting of a tastant, a flavorant, a preservative, a stabilizer, a binder, a compaction agent, a lubricant, a dispersion enhancer, a disintegration agent, a flavoring agent, a sweetener, and a coloring agent; wherein the excipient is not naturally occurring;

wherein the nutritive polypeptide is present in an amount sufficient to provide a nutritional benefit to a human subject suffering from protein malnutrition or a disease, disorder or condition characterized by protein malnutrition.

4. The formulation of claim 3 , wherein the nutritive polypeptide is formulated in a pharmaceutically acceptable carrier.

5. The formulation of claim 3 , wherein the nutritive polypeptide is formulated in or as a food or a food ingredient, or as a medical food or as a medical food ingredient.

6. The formulation of claim 3 , wherein the nutritive polypeptide is formulated in or as a beverage or a beverage ingredient.

7. The formulation of claim 3 , wherein the isolated nutritive polypeptide has an aqueous solubility at pH 7 of at least 12.5 g/L.

8. The formulation of claim 3 , wherein the isolated nutritive polypeptide has a simulated gastric digestion half-life of less than 30 minutes.

9. The formulation of claim 3 , further comprising a component selected from a 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, and a pharmaceutical.

10. The formulation of claim 3 , wherein the amino acid sequence contains a density of branched chain amino acids about equal to or greater than the density of branched chain amino acids present in full-length bovine beta lactoglobulin or bovine type I collagen.

11. The formulation of claim 3 , wherein the amino acid sequence contains a density of essential amino acids about equal to or greater than the density of essential chain amino acids present in full-length bovine beta lactoglobulin or bovine type I collagen.

12. The formulation of claim 3 , wherein the amino acid sequence contains a density of at least one amino acid selected from the group consisting of leucine, arginine and glutamine about equal to or greater than the density of the selected amino acid present in full-length bovine beta lactoglobulin or bovine type I collagen.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 20, 2023
From: AXCELLA HEALTH INC.
To: AXCELLA (ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC
Reel/Frame 066125/0228 →
RELEASE OF SECURITY INTEREST Recorded Dec 15, 2022
From: SLR INVESTMENT CORP.
To: AXCELLA HEALTH INC.
Reel/Frame 062137/0569 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 2, 2021
From: AXCELLA HEALTH INC.
To: SLR INVESTMENT CORP., AS AGENT
Reel/Frame 057435/0136 →
CORRECTIVE ASSIGNMENT TO CORRECT THE 11TH ASSIGNOR'S NAME PREVIOUSLY RECORDED AT REEL: 052211 FRAME: 0526. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 20, 2021
From: HAMILL, MICHAEL; BOGHIGIAN, BRETT; HARVEY, CAITLYN; KRAMARCZYK, JOHN; HEARD, KATHRYN; DOHERTY, MICHAEL; SILVER, NATHANIEL; VON MALTZAHN, GEOFFREY; YOUNG, DAVID; ROGERS, JAMESON; SAMAYOA, PHILLIP; BASU, SUBHAYU; VAIDYA, VIMAL; CHEN, YING-JA; RAHMAN, SHAILA; BERRY, DAVID
To: PRONUTRIA BIOSCIENCES, INC.
Reel/Frame 057249/0607 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 24, 2020
From: HAMILL, MICHAEL; BOGHIGIAN, BRETT; HARVEY, CAITLYN; KRAMARCZYK, JOHN; HEARD, KATHRYN; DOHERTY, MICHAEL; SILVER, NATHANIEL; VON MALTZAHN, GEOFFREY; YOUNG, DAVID; ROGERS, JAMESON; SAMOYOA, PHILLIP; BASU, SUBHAYU; VAIDYA, VIMAL; CHEN, YING-JA; RAHMAN, SHAILA; BERRY, DAVID
To: PRONUTRIA BIOSCIENCES, INC.
Reel/Frame 052211/0526 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 24, 2020
From: PRONUTRIA BIOSCIENCES, INC.
To: AXCELLA HEALTH INC.
Reel/Frame 052216/0318 →
Continuity (35)
Continuation 16585357 · Sep 27, 2019
Continuation 15081004 · Mar 25, 2016
Continuation In Part PCTUS2014057527 · Sep 25, 2014
Continuation In Part PCTUS2014057528 · Sep 25, 2014
Continuation PCTUS2014057526 · Sep 25, 2014
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