# US 12,760,071 B2 · Supramolecular polypeptide compositions and methods of making and using the same

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- Number: US 12,760,071 B2
- Document ID: US12760071B2
- Status: Granted
- Kind: B2
- Application number: 17/608,443
- Filed: 2020-05-04
- Published: 2022-06-23
- Granted: 2026-10-13
- Earliest claimed: 2019-05-02
- Assignees: Duke University
- Applicants: Duke University
- Inventors: Joel Collier; Nicole Votaw
- Web page: https://patentgrep.com/patent/US12760071B2

## CPC

- C07K 14/001: {by chemical synthesis}
- A61K 38/16: Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof {(enzyme inhibitors A61K38/005)}
- 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)
- 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 a supramolecular (self-assembling) polypeptide complex that comprises a plurality of randomized polyamino acids that self-assemble into nanofibers and methods of making and using same.

## Claims

### Claim 1

A polypeptide molecule consisting of a self-assembling polypeptide consisting of SEQ ID NO:1 (Q11) linked to a random polypeptide at least ten amino acids in length, wherein each amino acid in the random polypeptide is independently selected from lysine, glutamic acid, tyrosine, and alanine; and optionally wherein the self-assembling polypeptide is linked to the random polypeptide via a spacer, wherein the spacer is a polypeptide and is at least three amino acids in length and less than 10 amino acids in length.

### Claim 2 (depends on 1)

The polypeptide molecule of claim 1, wherein the self-assembling polypeptide is capable of forming nanofibers in solution.

### Claim 3 (depends on 1)

The polypeptide molecule of claim 1, wherein the self-assembling polypeptide assembles to form a β-sheet or an α-helix.

### Claim 4 (depends on 1)

The polypeptide molecule of claim 1, wherein the random polypeptide is at least 20 amino acids in length.

### Claim 5 (depends on 1)

The polypeptide molecule of claim 1, wherein the self-assembling polypeptide is linked to the random polypeptide via a spacer, wherein the spacer is a polypeptide and is at least three amino acids in length and less than 10 amino acids in length.

### Claim 6 (depends on 5)

The polypeptide molecule of claim 5, wherein the spacer is a polypeptide is selected from the group consisting of SGSG (SEQ ID NO:68), GGGG (SEQ ID NO: 69), GSGS (SEQ ID NO:70), EAAK (SEQ ID NO:71), EAAAK (SEQ ID NO:72), a poly serine sequence, a poly glycine sequence, a poly alanine sequence, and combinations thereof.

### Claim 7 (depends on 1)

The polypeptide molecule of claim 1, wherein at least one of the at least ten amino acids in the random polypeptide is tyrosine.

### Claim 8 (depends on 1)

The polypeptide molecule of claim 1, wherein in the random polypeptide at least one of the at least ten amino acids is lysine, at least one of the at least ten amino acids is glutamic acid, at least one of the at least ten amino acids is tyrosine, and at least one of the at least ten amino acids is alanine.

### Claim 9 (depends on 1)

A pharmaceutical composition, comprising the polypeptide molecule of claim 1 and a pharmaceutically acceptable carrier or excipient.

### Claim 10 (depends on 9)

The pharmaceutical composition of claim 9, further comprising a second polypeptide molecule consisting of a self-assembling peptide consisting of SEQ ID NO: 1 linked to a peptide epitope or antigen.

### Claim 11 (depends on 1)

A kit comprising the polypeptide molecule of claim 1 and instructions for use.

### Claim 12 (depends on 9)

The pharmaceutical composition of claim 9, wherein the pharmaceutically acceptable carrier or excipient is an isotonic solution, and wherein the self-assembling polypeptide linked to a random polypeptide forms nanofibers in solution.

### Claim 13 (depends on 1)

A method of making the polypeptide molecule of claim 1, the method comprising:
(a) creating a self-assembling polypeptide through solid phase peptide synthesis;
(b) optionally linking a spacer onto the self-assembling polypeptide;
(c) creating a random polypeptide by reacting at least three amino acids in equal parts to attach one of the at least three amino acids to the self-assembling polypeptide and optional spacer randomly; and
(d) repeating step (c) to add at least 10 amino acids independently selected from lysine, glutamic acid, tyrosine, and alanine to form the polypeptide molecule comprising the random polypeptide linked to the self-assembling polypeptide.
