# US 10,946,068 B2 · IL-2 muteins and uses thereof

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- Number: US 10,946,068 B2
- Document ID: US10946068B2
- Status: Granted
- Kind: B2
- Application number: 16/203,018
- Filed: 2018-11-28
- Published: 2019-10-24
- Granted: 2021-03-16
- Earliest claimed: 2017-12-06
- Assignees: Pandion Operations, Inc.
- Applicants: Pandion Therapeutics, Inc.
- Inventors: Nathan Higginson-Scott; Joanne L. Viney; Jyothsna Visweswaraiah; Erik Robert Sampson; Kevin Lewis Otipoby
- Web page: https://patentgrep.com/patent/US10946068B2

## CPC

- A61K 38/2013: {IL-2}
- A61K 39/39533: {against materials from animals}
- A61K 47/6813: {the drug being a peptidic cytokine, e.g. an interleukin or interferon}
- C07K 14/55: IL-2
- 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)
- 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

The present application provides for IL-2 muteins, compositions comprising the same, and methods of using the same.

## Claims

### Claim 1

A method of increasing I regulatory cell proliferation in a subject, the method comprising administering to the subject an effective amount of a pharmaceutical composition comprising a peptide comprising the amino acid sequence of SEQ ID NO: 26 wherein the I regulatory cell proliferation is increased in the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the peptide further comprises a N-terminal leader peptide having the amino acid sequence of SEQ. ID. No: 7.

### Claim 3 (depends on 1)

The method of claim 1, wherein the peptide further comprises a linker peptide at the C-terminus.

### Claim 4 (depends on 3)

The method of claim 3, wherein the linker peptide comprises the sequence of (GGGGS)n, wherein n is 1, 2, 3, or 4.

### Claim 5 (depends on 1)

The method of claim 1, wherein the peptide further comprises a Fc peptide.

### Claim 6 (depends on 5)

The method of claim 5, wherein the Fc peptide comprises the amino acid sequence of SEQ ID NO: 8 or SEQ ID NO: 15.

### Claim 7 (depends on 5)

The method of claim 5, wherein the peptide further comprises a leader peptide having the sequence of SEQ. ID. No: 7 at the N-terminus of the peptide.

### Claim 8 (depends on 5)

The method of claim 5, wherein the Fc peptide is at the C-terminus of the peptide.

### Claim 9 (depends on 5)

The method of claim 5, wherein the Fc peptide is at the N-terminus of the peptide.

### Claim 10 (depends on 5)

The method of claim 5, wherein the peptide further comprises a linker peptide that links the peptide of SEQ ID NO: 26 and the Fc peptide.

### Claim 11 (depends on 10)

The method of claim 10, wherein the peptide further comprises a N-terminal leader peptide having the amino acid sequence of SEQ. ID. No: 7 at the N terminus.

### Claim 12 (depends on 10)

The method of claim 10, wherein the linker peptide comprises the sequence of is (GGGGS)n, wherein n is 1, 2, 3, or 4.

### Claim 13 (depends on 10)

The method of claim 10, wherein the Fc peptide comprises the amino acid sequence of SEQ ID NO: 8 or SEQ ID NO: 15.

### Claim 14 (depends on 10)

The method of claim 10, wherein the Fc peptide is at the C-terminus of the peptide.

### Claim 15 (depends on 10)

The method of claim 10, wherein the Fc peptide is at the N-terminus of the peptide.

### Claim 16 (depends on 10)

The method of claim 10, wherein the peptide comprises the amino acid sequence of SEQ ID NO: 40.

### Claim 17 (depends on 1)

The method of claim 1 wherein the method further comprises activating the T regulatory cells.

### Claim 18

A method of activating T regulatory cells in a subject, the method comprising administering to the subject an effective amount of a pharmaceutical composition comprising a peptide comprising the amino acid sequence of SEQ ID NO: 26, wherein the I regulatory cells are activated in the subject.

### Claim 19 (depends on 2)

The method of claim 2, wherein the peptide further comprises a Fc peptide.

### Claim 20 (depends on 19)

The method of claim 19, wherein the Fc peptide is at the C-terminus or the N-terminus of the peptide.

### Claim 21 (depends on 19)

The method of claim 19, wherein the peptide comprises the amino acid sequence of SEQ ID NO: 40.

### Claim 22 (depends on 1)

The method of claim 1, wherein the peptide further comprises a linker peptide at the N-terminus.

### Claim 23 (depends on 14)

The method of claim 14, wherein the peptide linker links the N-terminus of the Fc peptide to the C-terminus of the peptide.

### Claim 24 (depends on 15)

The method of claim 15, wherein the peptide linker links the C-terminus of the Fc peptide to the N-terminus of the peptide.

### Claim 25 (depends on 22)

The method of claim 22, wherein the linker peptide comprises the sequence of (GGGGS)n, wherein n is 1, 2, 3, or 4.

### Claim 26 (depends on 23)

The method of claim 23, wherein the linker peptide comprises the sequence of (GGGGS)n, wherein n is 1, 2, 3, or 4.

### Claim 27 (depends on 24)

The method of claim 24, wherein the linker peptide comprises the sequence of (GGGGS)n, wherein n is 1, 2, 3, or 4.