# US 2013/0156694 A1 · Hsp70 fusion protein conjugates and uses thereof

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- Number: US 2013/0156694 A1
- Document ID: US20130156694A1
- Status: Published application
- Kind: A1
- Application number: 13/716,087
- Filed: 2012-12-15
- Published: 2013-06-20
- Earliest claimed: 2011-12-15
- Assignees: Alternative Innovative Technologies LLC
- Inventors: Sergei B. Onikienko; Alex Nivorozhkin; Alexander V. Zemlyanoi; Mikhail Viktorovich Shorokhov; Vladimir Ivanovich Pereguda; Valery Aleksandrovich Chereshnev
- Web page: https://patentgrep.com/patent/US20130156694A1

## CPC

- C07K 14/47: from mammals
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/435: from animals; from humans
- C07K 16/46: Hybrid immunoglobulins (hybrids of an immunoglobulin with a peptide not being an immunoglobulin C07K19/00)
- A61K 38/1709: {from mammals}
- C07K 2319/00: Fusion polypeptide
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C07K 2319/50: containing protease site
- 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)
- 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 invention relates to novel therapies that utilize HSP70 fusion proteins for the treatment of disorders or conditions regulated by HSP70.

## Claims

### Claim 1

An HSP70 fusion protein comprising (i) a first HSP70 domain fused to (ii) a second Fc domain, wherein the first and second domains are optionally linked by a third linker domain.

### Claim 2 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the HSP70 domain is human heat shock protein 70.

### Claim 3 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the HSP70 domain is a recombinant human heat shock protein 70 (rhHSP70).

### Claim 4 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the HSP70 domain is pegylated HSP70.

### Claim 5 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the Fc domain is a constant Fc fragment of human immunoglobulin G (IgG).

### Claim 6 (depends on 5)

The HSP70 fusion protein of claim 5, wherein the IgG is IgG1, IgG2, IgG3, or IgG4.

### Claim 7 (depends on 5)

The HSP70 fusion protein of claim 5, wherein the IgG is IgG1.

### Claim 8 (depends on 5)

The HSP70 fusion protein of claim 5, wherein the IgG is IgG3.

### Claim 9 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the linker domain is present, and comprises a spacer moiety.

### Claim 10 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the linker domain is present, and comprises a cleavable moiety.

### Claim 11 (depends on 10)

The HSP70 fusion protein of claim 10, wherein the cleavable moiety is cleavable by the action of a protease.

### Claim 12 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the linker domain is absent.

### Claim 13 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the Fc domain is fused to the C-terminus of the HSP70 domain.

### Claim 14 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the Fc domain is fused to the N-terminus of the HSP70 domain.

### Claim 15 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the HSP70 fusion protein is an amino acid sequence represented by SEQ ID NO: 1.

### Claim 16 (depends on 1)

The HSP70 fusion protein of claim 1, wherein the HSP70 fusion protein is labeled with one or more radioactive isotopes.

### Claim 17 (depends on 16)

The HSP70 fusion protein of claim 16, wherein the radioactive isotope is selected from the group consisting of I-123, I-124, I-125 and I-131.

### Claim 18

A pharmaceutical composition comprising an HSP70 fusion protein, wherein the HSP70 fusion protein comprises (i) a first HSP70 domain fused to (ii) a second Fc domain, wherein the first and second domains are optionally linked by a third linker domain, and pharmaceutically acceptable carrier.

### Claim 19 (depends on 18)

The pharmaceutical composition of claim 18, wherein the HSP70 fusion protein is an amino acid sequence represented by SEQ ID NO: 1.

### Claim 20 (depends on 18)

The pharmaceutical composition of claim 18, wherein the HSP70 fusion protein is labeled with one or more radioactive isotopes.

### Claim 21 (depends on 20)

The pharmaceutical composition of claim 20, wherein the radioactive isotope is selected from the group consisting of I-123, I-124, I-125 and I-131.

### Claim 22 (depends on 18)

The pharmaceutical composition of claim 18 formulated for intravenous, intrapulmonary, subcutaneous, intranasal, oral, or inhalation administration.

### Claim 23

A method of treatment of an HSP70 related disorder or condition, wherein the method comprises administering to a subject a therapeutically effective amount of HSP70 fusion protein, and wherein the HSP70 fusion protein comprises (i) a first HSP70 domain fused to (ii) a second Fc domain, wherein the first and second domains are optionally linked by a third linker domain,
such that the HSP70 related disorder or condition is treated in the subject.

### Claim 24 (depends on 23)

The method of claim 23, wherein the HSP70 related disorder or condition is selected from the group consisting of cancer; sepsis; cardiac injury; muscular injury and degeneration; fibrosis, including liver, pulmonary and cystic fibrosis; recovery from physical and exercise stress; neuro-degeneration including Parkinson disease, Alzheimer disease, Huntington disease, and amyotrophic lateral sclerosis; spinal cord injury; traumatic brain injury; stroke; acute lung injury; eye neurodegenerative diseases including glaucoma and macular degeneration; and epilepsy.

### Claim 25

A method to increase performance, alleviate fatigue syndrome, or treat muscle damage or muscle degeneration comprising administering to a mammal a therapeutically effective amount of HSP70 fusion protein, and wherein the HSP70 fusion protein comprises (i) a first HSP70 domain fused to (ii) a second Fc domain, wherein the first and second domains are optionally linked by a third linker domain,
such that performance is increased, the fatigue syndrome is alleviated, or the muscle damage or muscle degeneration is treated in the mammal.

### Claim 26

A method of radioimmunotherapy comprising administering to a subject a therapeutically effective amount of HSP70 fusion protein, wherein the HSP70 fusion protein comprises (i) a first HSP70 domain fused to (ii) a second Fc domain, wherein the first and second domains are optionally linked by a third linker domain, and wherein the HSP70 fusion protein is labeled with one or more radioactive isotopes,
such that cancer is treated in the subject.

### Claim 27 (depends on 26)

The method of claim 26, wherein the radioactive isotope is selected from the group consisting of I-123, I-124, I-125 and I-131.

### Claim 28 (depends on 26)

The method of claim 26, wherein the cancer is melanoma.

### Claim 29 (depends on 26)

The method of claim 26, wherein the method further comprises the step of using the radioactive isotopes to image the cancer.

### Claim 30 (depends on 23)

The method of claim 23, wherein the HSP70 fusion protein is an amino acid sequence represented by SEQ ID NO: 1.