# US 11,111,283 B2 · Peptides and compositions for treatment of joint damage

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- Number: US 11,111,283 B2
- Document ID: US11111283B2
- Status: Granted
- Kind: B2
- Application number: 16/270,371
- Filed: 2019-02-07
- Published: 2019-05-30
- Granted: 2021-09-07
- Earliest claimed: 2013-03-08
- Assignees: Novartis AG
- Applicants: Novartis AG
- Inventors: Kristen Johnson; Jian Shi
- Web page: https://patentgrep.com/patent/US11111283B2

## CPC

- C07K 14/515: Angiogenesic factors; Angiogenin
- A61K 31/728: Hyaluronic acid
- A61K 35/32: Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
- A61K 38/1709: {from mammals}
- A61K 38/1891: {Angiogenesic factors; Angiogenin}
- A61K 38/385: {Serum albumin}
- A61K 38/45: Transferases (2)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- C07K 14/47: from mammals
- C12N 5/0655: {Chondrocytes; Cartilage}
- C12N 15/00: Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor (mutants or genetically engineered microorganisms, per se C12N1/00, C12N5/00, C12N7/00; new plants per se A01H; plant reproduction by tissue culture techniques A01H4/00; new animals per se A01K67/00; use of medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases, gene therapy A61K48/00)
- C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- C12Q 1/6883: for diseases caused by alterations of genetic material
- G01N 33/6887: {from muscle, cartilage or connective tissue}
- 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 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C12N 15/11: DNA or RNA fragments; Modified forms thereof (DNA or RNA not used in recombinant technology, C07H21/00); {Non-coding nucleic acids having a biological activity}
- C12N 2501/17: Angiopoietin
- C12N 2506/1346: from mesenchymal stem cells
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- G01N 2333/78: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- G01N 2800/105: Osteoarthritis, e.g. cartilage alteration, hypertrophy of bone
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention provides new protease resistant polypeptides, as well as compositions and methods for treating, ameliorating or preventing conditions related to joint damage, including acute joint injury and arthritis.

## Claims

### Claim 1

An isolated polynucleotide encoding a polypeptide having at least 95% amino acid sequence identity to a polypeptide consisting of the amino acid sequence set forth as SEQ ID NO: 28, wherein the polypeptide comprises an amino acid that is a polar amino acid other than K or R at position 423 as determined with reference to SEQ ID NO:1, and wherein the polypeptide has chondrogenic activity.

### Claim 2 (depends on 1)

The isolated polynucleotide according to claim 1, which is complementary DNA (cDNA) or messenger RNA (mRNA).

### Claim 3 (depends on 1)

The isolated polynucleotide according to claim 1, wherein the encoded polypeptide further comprises a secretion signal sequence.

### Claim 4 (depends on 1)

The isolated polynucleotide according to claim 1, wherein the encoded polypeptide further comprises a fusion domain selected from the group consisting of a polyhistidine, Glu-Glu, glutathione S transferase (GST), thioredoxin, protein A, protein G, an immunoglobulin heavy chain constant region (Fc), maltose binding protein (MBP), a human serum albumin (HSA), a FLAG tag, influenza virus haemagglutinin (HA), and a c-myc tag.

### Claim 5 (depends on 1)

The isolated polynucleotide according to claim 1, which is codon-optimized for expression in a host cell.

### Claim 6 (depends on 1)

The isolated polynucleotide according to claim 1, which is operably linked to a promoter or other regulatory sequence.

### Claim 7 (depends on 1)

A cloning or expression vector comprising one or more polynucleotides according to claim 1, wherein the vector is suitable for the recombinant production of the encoded polypeptide.

### Claim 8 (depends on 7)

A host cell, comprising one or more cloning or expression vectors according to claim 7.

### Claim 9 (depends on 8)

The host cell of claim 8, which is a mammalian host cell, a bacterial host cell, a yeast host cell, or an insect host cell.

### Claim 10 (depends on 9)

A process for the production of a polypeptide, comprising culturing a host cell according to claim 9 under conditions sufficient to express the polypeptide, and thereafter purifying and recovering the polypeptide from the host cell culture.

### Claim 11 (depends on 1)

A kit comprising the polynucleotide according to claim 1, wherein the kit comprises: a first container comprising the polynucleotide; and a second container having an aqueous reconstitution formula.

### Claim 12 (depends on 11)

The kit according to claim 11, wherein one container comprises a single chambered pre-filled syringe.

### Claim 13 (depends on 11)

The kit according to claim 11, wherein the containers are encompassed as a multi-chambered pre-filled syringe.