# US 11,077,169 B2 · Soy-derived bioactive peptides for use in compositions and methods for wound healing, tissue engineering, and regenerative medicine

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- Number: US 11,077,169 B2
- Document ID: US11077169B2
- Status: Granted
- Kind: B2
- Application number: 15/746,508
- Filed: 2016-07-21
- Published: 2018-07-26
- Granted: 2021-08-03
- Earliest claimed: 2015-07-22
- Assignees: Temple University of the Commonwealth System of Higher Education
- Applicants: Temple University-Of The Commonwealth System of Higher Education
- Inventors: Peter I. Lelkes; Yah-El H. Har-el; Cezary Marcinkiewicz; Philip Lazarovici; Sogol Moaiyed Baharlou; Jonathan A. Gerstenhaber
- Web page: https://patentgrep.com/patent/US11077169B2

## CPC

- A61K 38/168: {from plants}
- A61L 15/26: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof {(A61L15/225 takes precedence)}
- A61L 15/32: Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin {(A61L15/225 takes precedence)}
- A61L 15/44: Medicaments
- A61L 26/0019: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds}
- A61L 26/0047: {Specific proteins or polypeptides not covered by groups A61L26/0033 - A61L26/0042}
- A61L 26/0066: {Medicaments; Biocides}
- A61L 26/008: {Hydrogels or hydrocolloids}
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/222: {Gelatin}
- A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24}
- A61L 27/52: Hydrogels or hydrocolloids
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61L 2300/252: Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Compositions and methods for the promotion of wound healing and tissue regeneration are described. The compositions and methods make use of water-soluble soy protein isolates (WSsoy), Fraction 5, Fraction 9, and/or bioactive peptide components of soy protein isolates. The invention also relates to the unexpected discovery that purified WSsoy forms gel-like matrices when suspended within certain concentration ranges in an aqueous environment. The compositions of the invention comprising WSsoy promote natural healing and have a low risk profile.

## Claims

### Claim 1

A composition for inducing wound healing and tissue regeneration, wherein the composition comprises a bioactive peptide component of a soy protein isolate (SPI), wherein the SPI comprises a water soluble soy protein isolate (WSsoy), and wherein the composition comprises a protein Fraction 5 eluted during separation of WSsoy using reverse phase-high pressure liquid chromatography (RP-HPLC) using C18 with a linear gradient of elution (0-80% acetonitrile (ACN)) over 45 minutes, wherein Fraction 5 has a retention time of about 25-35 minutes and a zeta potential of about 17.9 mV.

### Claim 2 (depends on 1)

A method for promoting wound healing and tissue regeneration in a subject in need thereof, the method comprising administering the composition of claim 1 to a treatment site on the subject.

### Claim 3 (depends on 1)

A scaffold for inducing wound healing and tissue regeneration, wherein the scaffold comprises the composition of claim 1.

### Claim 4 (depends on 3)

The scaffold of claim 3, wherein the scaffold comprises at least one selected from the group consisting of: electroprocessed fibers comprising the bioactive peptide component of SPI, electroprocessed fibers comprising a synthetic polymer, electroprocessed fibers comprising Fraction 9 acting as ligand for α9β1 integrin, Fraction 5 in soluble form, Fraction 5 loaded within a drug delivery vehicle, a hydrogel comprising the bioactive peptide component of SPI, and a hydrogel comprising gelatin crosslinked with genipin.

### Claim 5 (depends on 4)

The scaffold of claim 4, wherein the synthetic polymer is selected from the group consisting of poly (epsilon-caprolactone) (PCL), poly (lactic acid) (PLA), poly (glycolic acid) (PGA), copolymers poly (lactide-co-glycolide) (PLGA), polyaniline, poly(ethylene oxide) (PEO), and any combination thereof.

### Claim 6 (depends on 3)

A method of promoting wound healing and tissue regeneration in a subject in need thereof, the method comprising administering the scaffold of claim 3 to a treatment site on the subject.

### Claim 7

A composition for inducing wound healing and tissue regeneration, wherein the composition comprises a bioactive peptide component of a soy protein isolate (SPI), wherein the SPI comprises a water soluble soy protein isolate (WSsoy), and wherein the composition comprises a protein Fraction 9 eluted during separation of WSsoy using reverse phase-high pressure liquid chromatography (RP-HPLC) using C18 with a linear gradient of elution (0-80% acetonitrile (ACN)) over 45 minutes, wherein Fraction 9 has a retention time of about 35-40 minutes and a zeta potential of about 34.2 mV, and contains β-conglycinin or fragments thereof having an Leu-Asp-Val (LDV) motif.

### Claim 8 (depends on 7)

A scaffold for inducing wound healing and tissue regeneration, wherein the scaffold comprises the composition of claim 7.

### Claim 9 (depends on 8)

The scaffold of claim 8, wherein the scaffold comprises at least one selected from the group consisting of: electroprocessed fibers comprising the bioactive peptide component of SPI, electroprocessed fibers comprising a synthetic polymer, electroprocessed fibers comprising Fraction 9 acting as ligand for α9β1 integrin, Fraction 5 in soluble form, Fraction 5 loaded within a drug delivery vehicle, a hydrogel comprising the bioactive peptide component of SPI, and a hydrogel comprising gelatin crosslinked with genipin.

### Claim 10 (depends on 8)

The scaffold of claim 8, wherein the synthetic polymer is selected from the group consisting of poly (epsilon-caprolactone) (PCL), poly (lactic acid) (PLA), poly (glycolic acid) (PGA), copolymers poly (lactide-co-glycolide) (PLGA), polyaniline, poly(ethylene oxide) (PEO), and any combination thereof.