# US 2019/0375797 A1 · METHODS AND THERAPEUTICS COMPRISING LIGAND-TARGETED ELPs

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2019/0375797 A1
- Document ID: US20190375797A1
- Status: Published application
- Kind: A1
- Application number: 16/230,698
- Filed: 2018-12-21
- Published: 2019-12-12
- Earliest claimed: 2012-02-13
- Assignees: University of Southern California
- Inventors: Sarah Hamm-Alvarez; John Andrew MacKay; Guoyong Sun; Pang-Yu Hsueh
- Web page: https://patentgrep.com/patent/US20190375797A1

## CPC

- A61K 47/6435: {the peptide or protein in the drug conjugate being a connective tissue peptide, e.g. collagen, fibronectin or gelatin}
- C07K 14/005: from viruses
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- 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)
- A61K 49/0043: {Fluorescein, used in vivo}
- A61K 49/0056: {Peptides, proteins, polyamino acids}
- C07K 14/001: {by chemical synthesis}
- C07K 16/283: {against Fc-receptors, e.g. CD16, CD32, CD64 (CD23 C07K16/2851)}
- C07K 2319/33: fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
- C07K 2319/74: containing a fusion for binding to a cell surface receptor
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12N 2710/10033: Use of viral protein as therapeutic agent other than vaccine, e.g. apoptosis inducing or anti-inflammatory
- 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)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Disclosed herein are novel methods and compositions for targeting drug delivery systems to specific cells. One aspect relates to a drug delivery system comprising an elastin-like peptide (ELP) component and a ligand selected from the group consisting of mIgA and knob capable of either drug encapsulation or drug attachment. Further aspects relate to drug delivery systems comprising an elastin-like peptide (ELP) component and a ligand; wherein the ligand specifically binds to a receptor selected from the group consisting of CAR and pIgR. Further aspects include the novel transcytosing properties of the elastin-like peptide and the ligand, knob. Also provided are methods and pharmaceutical compositions comprising the disclosed therapeutics.

## Claims

### Claim 1

A drug delivery agent comprising an elastin-like peptide (ELP) component and a ligand component, wherein:
(a) the ligand component specifically binds to a CAR and/or pIgR receptor; and/or
(b) the ligand component is mIgA and/or knob ligand, or a biological equivalent thereof of the mIgA or knob ligand.

### Claim 2 (depends on 1)

The drug delivery agent of claim 1, further comprising an anticancer drug.

### Claim 3 (depends on 1)

The drug delivery agent of claim 1, wherein the ELP component comprises a diblock.

### Claim 4 (depends on 3)

The drug delivery agent of claim 3, wherein the ELP component comprises a polypeptide with a sequence selected from: (VPGSG)48(VPGIG)48 (SEQ ID NO: 12), (VPGSG)96 (SEQ ID. NO: 13), or (VPGIG)96 (SEQ ID. NO: 14).

### Claim 5 (depends on 1)

The drug delivery agent of claim 1, wherein the ligand component is a mIgA ligand.

### Claim 6 (depends on 5)

The drug delivery agent of claim 5, wherein the mIgA ligand comprises a polypeptide having the sequence of SEQ ID. NO: 5 or a biological equivalent thereof.

### Claim 7 (depends on 1)

The drug delivery agent of claim 1, wherein the ligand component is a knob ligand.

### Claim 8 (depends on 7)

The drug delivery agent of claim 7, wherein the knob ligand comprises a polypeptide having the sequence of SEQ ID. NO: 4 or a biological equivalent thereof.

### Claim 9 (depends on 1)

A polynucleotide encoding the drug delivery agent of claim 1.

### Claim 10 (depends on 9)

A method for preparing a drug delivery agent, comprising expressing the polynucleotide of claim 9.

### Claim 11 (depends on 1)

A method for delivering a drug comprising an elastin-like peptide (ELP) to a cell, comprising contacting the cell with the drug delivery agent of claim 1, wherein:
(a) the ligand component specifically binds to a CAR and/or pIgR receptor; and/or
(b) the ligand component is mIgA and/or knob ligand, or a biological equivalent thereof of the mIgA or knob ligand.

### Claim 12 (depends on 1)

A method for delivering a drug to the luminal area of LGACs by transcytosis, comprising contacting the LGAC with the drug delivery agent of claim 1, wherein:
(a) the ligand component specifically binds to a CAR and/or pIgR receptor; and/or
(b) the ligand component is mIgA and/or knob ligand, or a biological equivalent thereof of the mIgA or knob ligand.

### Claim 13 (depends on 12)

The method of claim 12, wherein the drug is in contact with the ocular surface of the eye.

### Claim 14 (depends on 12)

The method of claim 12, wherein the drug is released from interstitial to luminal surfaces on a mucosal epithelial cell.

### Claim 15 (depends on 11)

The method of claim 11, wherein the cell is one or more of a mucosal cell, an epithelial cell or a hepatocyte and/or contained within a lacrimal gland or tissue.

### Claim 16 (depends on 1)

A method for treating a disease of the lacrimal gland, comprising administering to a patient in need of such treatment the drug delivery agent of claim 1 wherein:
(a) the ligand component specifically binds to a CAR and/or pIgR receptor; and/or
(b) the ligand component is mIgA and/or knob ligand, or a biological equivalent thereof of the mIgA or knob ligand, thereby treating the patient.

### Claim 17 (depends on 16)

The method of claim 16, wherein the disease is cancer or Sjorgren's Syndrome.