# US 10,869,909 B2 · Compositions and methods of use for treating metabolic disorders

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- Number: US 10,869,909 B2
- Document ID: US10869909B2
- Status: Granted
- Kind: B2
- Application number: 16/221,139
- Filed: 2018-12-14
- Published: 2019-06-20
- Granted: 2020-12-22
- Earliest claimed: 2012-03-27
- Assignees: NGM Biopharmaceuticals, Inc.
- Applicants: NGM Biopharmaceuticals, Inc.
- Inventors: Darrin Anthony Lindhout; Peng Zhang; Thomas Frederick Parsons
- Web page: https://patentgrep.com/patent/US10869909B2

## CPC

- A61K 38/18: Growth factors; Growth regulators
- A61K 38/1841: {Transforming growth factor [TGF]}
- A61K 38/38: Albumins
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/60: the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/08: for glucose homeostasis (pancreatic hormones A61P5/48)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- C07K 14/475: Growth factors; Growth regulators
- C07K 14/495: Transforming growth factor [TGF]
- 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 2039/505: {comprising antibodies}
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- 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
- 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)

## Abstract

Methods of treating individuals with a glucose metabolism disorder and/or a body weight disorder, and compositions associated therewith, are provided.

## Claims

### Claim 1

A GDF15 mutein comprising:
a polypeptide comprising the amino acid sequence set forth in:
(i) SEQ ID NO: 5;
(ii) SEQ ID NO: 9; or
(iii) SEQ ID NO: 11.

### Claim 2 (depends on 1)

The GDF15 mutein of claim 1, wherein the polypeptide comprises an albumin fusion, Fc-fusion, or fusion with a PEG mimetic.

### Claim 3 (depends on 1)

The GDF15 mutein of claim 1, wherein the polypeptide is pegylated.

### Claim 4 (depends on 3)

The GDF15 mutein of claim 3, wherein the pegylation increases the solubility of the peptide.

### Claim 5 (depends on 1)

The GDF15 mutein of claim 1, wherein the polypeptide is produced recombinantly.

### Claim 6 (depends on 1)

A nucleic acid molecule encoding the polypeptide of claim 1.

### Claim 7 (depends on 6)

The nucleic acid molecule of claim 6, wherein the nucleic acid molecule is operably linked to an expression control element that confers expression of the nucleic acid molecule encoding the polypeptide in vitro, in a cell, or in vivo.

### Claim 8 (depends on 6)

A vector comprising the nucleic acid molecule of claim 6.

### Claim 9 (depends on 8)

The vector of claim 8, wherein the vector comprises a viral vector.

### Claim 10 (depends on 1)

A transformed host cell that expresses the polypeptide of claim 1.

### Claim 11 (depends on 1)

A pharmaceutical composition, comprising the GDF15 mutein of claim 1, and a pharmaceutically acceptable diluent, carrier or excipient.

### Claim 12 (depends on 11)

The pharmaceutical composition of claim 11, further comprising at least one additional prophylactic or therapeutic agent.

### Claim 13 (depends on 11)

A sterile container comprising the pharmaceutical composition of claim 11.

### Claim 14 (depends on 13)

The sterile container of claim 13, wherein the sterile container is a syringe.

### Claim 15 (depends on 13)

A kit comprising the sterile container of claim 13.

### Claim 16 (depends on 15)

The kit of claim 15, further comprising a second sterile container comprising at least one additional prophylactic or therapeutic agent.

### Claim 17 (depends on 1)

A method of treating obesity or hyperglycemia in a mammalian subject, comprising administering to the mammalian subject a therapeutically effective amount of the GDF15 mutein of claim 1.

### Claim 18 (depends on 17)

The method of claim 17, wherein the polypeptide comprises an albumin fusion, Fc-fusion, or fusion with a PEG mimetic.

### Claim 19 (depends on 17)

The method of claim 17, wherein the polypeptide is pegylated.

### Claim 20 (depends on 19)

The method of claim 19, wherein the pegylation increases solubility.

### Claim 21 (depends on 17)

The method of claim 17, wherein the method comprises treating hyperglycemia in the mammalian subject and wherein the administering results in a reduction in blood glucose in the mammalian subject.

### Claim 22 (depends on 17)

The method of claim 17, wherein the method comprises treating obesity in the mammalian subject and wherein the administering results in a reduction in body weight in the mammalian subject.

### Claim 23 (depends on 17)

The method of claim 17, wherein the method comprises treating obesity in the mammalian subject and wherein the administering results in a reduction in food intake by the mammalian subject.

### Claim 24 (depends on 17)

The method of claim 17, wherein the mammalian subject has diabetes mellitus.

### Claim 25 (depends on 17)

The method of claim 17, wherein the mammalian subject is human.

### Claim 26 (depends on 25)

The method of claim 25, wherein the human is obese.

### Claim 27 (depends on 25)

The method of claim 25, wherein the human has diabetes mellitus.

### Claim 28 (depends on 17)

The method of claim 17, wherein the administering is by parenteral injection.

### Claim 29 (depends on 28)

The method of claim 28, wherein the parenteral injection is subcutaneous.

### Claim 30 (depends on 21)

The method of claim 21, wherein the polypeptide is pegylated.

### Claim 31 (depends on 22)

The method of claim 22, wherein the polypeptide is pegylated.

### Claim 32 (depends on 23)

The method of claim 23, wherein the polypeptide is pegylated.

### Claim 33 (depends on 24)

The method of claim 24, wherein the polypeptide is pegylated.

### Claim 34 (depends on 25)

The method of claim 25, wherein the polypeptide is pegylated.