# US 11,028,129 B2 · Compositions for expanding regulatory T cells (Treg) populations, and treating and ameliorating autoimmune diseases and conditions

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- Number: US 11,028,129 B2
- Document ID: US11028129B2
- Status: Granted
- Kind: B2
- Application number: 16/542,168
- Filed: 2019-08-15
- Published: 2020-04-09
- Granted: 2021-06-08
- Earliest claimed: 2014-09-29
- Assignees: The Regents of the University of California
- Applicants: The Regents of the University of California
- Inventors: Alessandra Franco
- Web page: https://patentgrep.com/patent/US11028129B2

## CPC

- C07K 7/08: having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68)
- A61K 9/127: Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 39/0005: {Vertebrate antigens (from snakes A61K39/38)}
- A61K 39/0008: {Antigens related to auto-immune diseases; Preparations to induce self-tolerance}
- 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 2039/545: {characterised by the dose, timing or administration schedule}
- 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

In alternative embodiments, provided are compositions, including e.g., isolated, synthetic or recombinant peptides or polypeptides, for: expanding regulatory T cells (Treg) populations; or, for treating, ameliorating, preventing or reversing a vascular inflammation, and Kawasaki disease (KD) or a pediatric acute vasculitis of the coronary arteries, including vascular coronary abnormalities and the same or similar types of acute or chronic vascular inflammatory abnormalities, and methods for making and using them. In one embodiment, provided are immunotherapies for promoting expansion of natural, regulatory T cells to establish, or re-establish, vascular homeostasis; or, for treating, reversing, preventing or ameliorating: a disease or condition associated with an autoimmune disease or condition; an immune-mediated vascular disorder; a disease or condition that is currently treated with intravenous immunoglobulin (WIG) therapy; a vascular coronary abnormality; an acute or a chronic vasculitis; an autoimmune inflammatory vasculitis; a T cell mediated pediatric vasculitis; Kawasaki disease (KD) or a pediatric acute vasculitis of the coronary arteries; atherosclerosis; rheumatoid arthritis or Juvenile Idiopathic Arthritis; an autoimmune disease or condition; or, a neoplastic hematological disorder such as a lymphoma (e.g., a T cell lymphoma) or a leukemia.

## Claims

### Claim 1

A pharmaceutical composition or a formulation comprising a plurality of isolated, synthetic or recombinant peptides or polypeptides comprising:
(SEQ ID NO: 1)
TAALGCLVKDYFPEP,
(SEQ ID NO: 2)
CLVKDYFPEPVTVSW,
(SEQ ID NO: 3)
SVFLFPPKPKDTLMI,
(SEQ ID NO: 9)
TFPAVLQSSGLYSLS,
(SEQ ID NO: 14)
TYRVVSVLTVLHQDW,
(SEQ ID NO: 16)
QGNVFSCSVMHEALH,
(SEQ ID NO: 22)
YFPEPVTVSWNSGAL,
(SEQ ID NO: 23)
VTVSWNSGALTSGVH,
(SEQ ID NO: 10)
LQSSGLYSLSSVVTV,
(SEQ ID NO: 11)
LYSLSSVVTVPSSSL,
(SEQ ID NO: 17)
SCSVMHEALHNHYTQ,
and
(SEQ ID NO: 45)
SVLTVLHQDWLNGKE,
and a pharmaceutically acceptable excipient.

### Claim 2 (depends on 1)

The pharmaceutical composition or formulation of claim 1, comprising a plurality of isolated, synthetic or recombinant peptides consisting essentially of:
(SEQ ID NO: 1)
TAALGCLVKDYFPEP,
(SEQ ID NO: 2)
CLVKDYFPEPVTVSW,
(SEQ ID NO: 3)
SVFLFPPKPKDTLMI,
(SEQ ID NO: 9)
TFPAVLQSSGLYSLS,
(SEQ ID NO: 14)
TYRVVSVLTVLHQDW,
(SEQ ID NO: 16)
QGNVFSCSVMHEALH,
(SEQ ID NO: 22)
YFPEPVTVSWNSGAL,
(SEQ ID NO: 23)
VTVSWNSGALTSGVH,
(SEQ ID NO: 10)
LQSSGLYSLSSVVTV,
(SEQ ID NO: 11)
LYSLSSVVTVPSSSL,
(SEQ ID NO: 17)
SCSVMHEALHNHYTQ,
and
(SEQ ID NO: 45)
SVLTVLHQDWLNGKE,
and a pharmaceutically acceptable excipient.

### Claim 3 (depends on 2)

The pharmaceutical composition or formulation of claim 2, comprising a plurality of isolated, synthetic or recombinant peptides consisting of:
(SEQ ID NO: 1)
TAALGCLVKDYFPEP,
(SEQ ID NO: 2)
CLVKDYFPEPVTVSW,
(SEQ ID NO: 3)
SVFLFPPKPKDTLMI,
(SEQ ID NO: 9)
TFPAVLQSSGLYSLS,
(SEQ ID NO: 14)
TYRVVSVLTVLHQDW,
(SEQ ID NO: 16)
QGNVFSCSVMHEALH,
(SEQ ID NO: 22)
YFPEPVTVSWNSGAL,
(SEQ ID NO: 23)
VTVSWNSGALTSGVH,
(SEQ ID NO: 10)
LQSSGLYSLSSVVTV,
(SEQ ID NO: 11)
LYSLSSVVTVPSSSL,
(SEQ ID NO: 17)
SCSVMHEALHNHYTQ,
and
(SEQ ID NO: 45)
SVLTVLHQDWLNGKE,
and a pharmaceutically acceptable excipient.

### Claim 4 (depends on 1)

The pharmaceutical composition or formulation of claim 1, wherein the pharmaceutical composition or formulation is a parenteral formulation; or the pharmaceutical composition or formulation is an oral or topical formulation.

### Claim 5 (depends on 1)

The pharmaceutical composition or formulation of claim 1, formulated as a sterile solution for injection.

### Claim 6 (depends on 1)

The pharmaceutical composition or formulation of claim 1, formulated as a liquid, an emulsion, a lyophilized powder, a spray, a cream, a lotion, a controlled release formulation, a tablet, a pill, a gel, a patch, in an implant or in a spray.

### Claim 7 (depends on 1)

The pharmaceutical composition or formulation of claim 1, wherein the pharmaceutical composition or formulation is a subcutaneous, an intravenous (IV), an intradermal, an intramuscular, an intraperitoneal, an intranasal, a transdermal or a buccal route formulation.

### Claim 8 (depends on 1)

The pharmaceutical composition or formulation of claim 1, wherein the pharmaceutical composition or formulation is an inhaled powder.

### Claim 9 (depends on 1)

The pharmaceutical composition or formulation of claim 1, wherein the pharmaceutical composition or formulation is a controlled release formulation.

### Claim 10 (depends on 1)

The pharmaceutical composition or formulation of claim 1, wherein the pharmaceutical composition or formulation is a tablet, a pill, a gel, a patch, in an implant or a spray formulation.

### Claim 11 (depends on 1)

The pharmaceutical composition or formulation of claim 1, formulated as a sterile solution for injection.

### Claim 12 (depends on 1)

The pharmaceutical composition or formulation of claim 1, formulated as a powder.

### Claim 13 (depends on 1)

The pharmaceutical composition or formulation of claim 1, formulated as a lyophilized or freeze-dried composition.

### Claim 14 (depends on 1)

The pharmaceutical composition or formulation of claim 1, formulated as an aqueous or a non-aqueous isotonic sterile injection solution or formulated an aqueous or a non-aqueous sterile suspension.

### Claim 15 (depends on 1)

The pharmaceutical composition or formulation of claim 1, wherein the plurality of peptides or polypeptides are synthetic peptides or polypeptides.

### Claim 16 (depends on 1)

The pharmaceutical composition or formulation of claim 1, wherein the plurality of peptides or polypeptides are recombinant peptides or polypeptides.

### Claim 17 (depends on 1)

A liposome comprising: a pharmaceutical or formulation of claim 1.

### Claim 18 (depends on 1)

A nanoparticle comprising: a pharmaceutical or formulation of claim 1.

### Claim 19 (depends on 1)

A vaccine comprising a pharmaceutical or formulation of claim 1.

### Claim 20 (depends on 19)

The vaccine of claim 19, further comprises an adjuvant.

### Claim 21 (depends on 20)

The vaccine of claim 20, wherein the adjuvant comprises an incomplete adjuvant.