# US 2020/0399310 A1 · Self-assembling peptide compositions

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- Number: US 2020/0399310 A1
- Document ID: US20200399310A1
- Status: Published application
- Kind: A1
- Application number: 15/931,073
- Filed: 2020-05-13
- Published: 2020-12-24
- Earliest claimed: 2014-03-10
- Assignees: 3-D Matrix, Ltd.
- Applicants: 3-D Matrix, Ltd.
- Inventors: Eun Seok Gil; Karl Gilbert; Manav Mehta
- Web page: https://patentgrep.com/patent/US20200399310A1

## CPC

- C07K 7/08: having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68)
- A61L 24/108: {Specific proteins or polypeptides not covered by groups A61L24/102 - A61L24/106}
- A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24}
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 19/04: for non-specific disorders of the connective tissue
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 25/00: Drugs for disorders of the nervous system
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- 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
- 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)

## Abstract

The present disclosure provides peptide compositions (e.g., of self-assembling peptides) with particular attributes (e.g., peptide identity, peptide concentration, pH, ionic strength [including salt identity and/or concentration), etc that show particularly useful material properties. The present disclosure also provides technologies for selecting and/or formulating particular peptide compositions useful in specific contexts. In some embodiments, provided peptide compositions have an elevated pH within the range of about 2.5 to about 3.5 and/or an ionic strength that is above that of a corresponding composition of the same peptide, at the same concentration, in water, but is below a critical salt point for the peptide (e.g., so that the composition is not cloudy).

## Claims

### Claim 1

An IEIK13 composition comprising:
an IEIK13 peptide at a concentration of at least 0.25%;
which composition has a pH within the range of about 2.5 to about 4.0.

### Claim 2 (depends on 1)

The composition of claim 1, which composition is a solution.

### Claim 3 (depends on 1)

The composition of claim 1, which composition is a gel.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the composition has ionic strength within the range of about 0.0001 M to about 0.1 M.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the ionic strength is adjusted/given by common salts, wherein the common salts are selected from the group consisting of NaCl, KCl, MgCl2, CaCl2, and CaSO4.

### Claim 6 (depends on 4)

The composition of claim 4, wherein the ionic strength is given by common salts, wherein the common salts are composed of one or more salt forming cations and one or more salt forming anions, wherein the salt forming cations are selected from the group consisting of ammonium, calcium, iron, magnesium, potassium, pyridinium, quaternary ammonium, and sodium, wherein the salt forming anions are selected from the group consisting of acetate, carbonate, chloride, citrate, cyanide, fluoride, nitrate, nitrite, and phosphate.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the composition has storage modulus within the range of about 100 to about 10000 Pa at 1 rad/sec of frequency and 1 Pa of oscillation stress.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the composition is buffered with sodium hydroxide, potassium hydroxide, calcium hydroxide, sodium carbonate, sodium acetate, sodium sulfide, or DMEM.

### Claim 9 (depends on 1)

The composition of claim 1, wherein:
the IEIK13 peptide is present at a concentration of less than 3% and/or
the composition has a pH within the range of about 3.0 to about 4.0.

### Claim 10 (depends on 9)

The composition of claim 9, which composition is a gel that exhibits a storage modulus of more than 500 Pa at 1 rad/sec of frequency and 1 Pa of oscillation stress.

### Claim 11 (depends on 1)

The composition of claim 1, wherein the composition is buffered with a sodium hydroxide, potassium hydroxide, calcium hydroxide, sodium carbonate, sodium acetate, or sodium sulfide, so that the pH of the composition is regulated.

### Claim 12

A liquid peptide composition comprising:
a peptide having a length within the range of about 6 to about 20 amino acids and an amino acid sequence of alternating hydrophobic amino acid and hydrophilic amino acids, which composition is characterized in that:
it has a viscosity within the range of about 1 Pa-s to about 500,000 Pa-s at room temperature
it has a storage modulus at 1 rad/sec of frequency and 1 Pa of oscillation stress within the range of about 1 to about 5000 Pa
it forms a gel within a time period about 0 to about 30 s when exposed to/maintained under pH within the range of about 2.5 to about 4.0 or and/or ionic strength within the range of about 0.0001 M to about 1.5 M.

### Claim at position 13 (depends on 12)

12A. The composition of claim 12, which is an aqueous composition.

### Claim 13 (depends on 12)

The composition of claim 12, wherein the peptide comprises RADA16.

### Claim 14 (depends on 12)

The composition of claim 12, wherein the peptide comprises IEIK13

### Claim 15 (depends on 12)

The composition of claim 12, wherein the peptide comprises KLD12.

### Claim 16 (depends on 12)

The composition of claim 12, wherein the ionic strength is given by common salts, wherein the common salts are selected from the group consisting of NaCl, KCl, MgCl2, CaCl2, and CaSO4.

### Claim 17 (depends on 12)

The composition of claim 12, wherein the ionic strength is given by common salts, wherein the common salts are composed of one or more salt forming cations and one or more salt forming anions, wherein the salt forming cations are selected from the group consisting of ammonium, calcium, iron, magnesium, potassium, pyridinium, quaternary ammonium, and sodium, wherein the salt forming anions are selected from the group consisting of acetate, carbonate, chloride, citrate, cyanide, fluoride, nitrate, nitrite, and phosphate.

### Claim 18 (depends on 12)

The composition of claim 12, wherein the composition is buffered with a sodium hydroxide, potassium hydroxide, calcium hydroxide, sodium carbonate, sodium acetate, or sodium sulfide, so that the pH of the composition is regulated.

### Claim 19

A method comprising steps of:
selecting a peptide composition for application to a particular in vivo site, the method comprising steps of:
determining one or more parameters selected from the group consisting of storage modulus, viscosity, gelation time, shear-thinning property, and peptide nano-fiber re-assembly time for the peptide composition; and
comparing the determined one or more parameters to a set of characteristics determined to be appropriate for application to the particular in vivo site; and
choosing the peptide composition in light of the comparison; and
administering the chosen peptide composition to the site.
