# US 11,999,771 B2 · IL-7Rαγc ligand immunoglobulin fusion proteins

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- Number: US 11,999,771 B2
- Document ID: US11999771B2
- Status: Granted
- Kind: B2
- Application number: 18/061,567
- Filed: 2022-12-05
- Published: 2023-10-12
- Granted: 2024-06-04
- Earliest claimed: 2022-04-07
- Assignees: Medikine, Inc.
- Applicants: Medikine, Inc.
- Inventors: William J. Dower; Ronald W. Barrett; Michael C. Needels; Steven E. Cwirla; Alice V. Bakker; Inkyung Park
- Web page: https://patentgrep.com/patent/US11999771B2

## CPC

- C07K 14/5418: {IL-7}
- A61K 38/2046: {IL-7}
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- 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 7/08: having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68)
- C07K 14/7155: {for interleukins [IL]}
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- 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

## Abstract

IL-7Rαγc ligands and IL-7Rαγc IgG-Fc fusion proteins are disclosed. The IL-7Rαγc ligands and IL-7Rαγc IgG-Fc fusion proteins are IL-7R agonists.

## Claims

### Claim 1

An IL-7Rαγc ligand comprising:
an IL-7Rα ligand comprising an amino acid sequence of SEQ ID NO: 1 or an amino acid sequence having greater than 70% sequence similarity to SEQ ID NO: 1; and
an Rγc ligand comprising an amino acid sequence of SEQ ID NO: 11 or an amino acid sequence having greater than 70% sequence similarity to SEQ ID NO: 11.

### Claim 2 (depends on 1)

The IL-7Rαγc ligand of claim 1, wherein the IL-7Rαγc ligand comprises:
an IL-7Rα ligand comprising an amino acid sequence of SEQ ID NO: 1 and
an Rγc ligand comprising an amino acid sequence of SEQ ID NO: 11.

### Claim 3 (depends on 1)

The IL-7Rαγc ligand of claim 1, wherein the IL-7Rαγc ligand comprises:
an IL-7Rα ligand comprising an amino acid sequence having greater than 70% sequence similarity to SEQ ID NO: 1; and
an Rγc ligand comprising an amino acid sequence having greater than 70% sequence similarity to SEQ ID NO: 11.

### Claim 4 (depends on 1)

The IL-7Rαγc ligand of claim 1, wherein the IL-7Rαγc ligand comprises:
an IL-7Rα ligand comprising an amino acid sequence based on SEQ ID NO: 1 and having from 1 to 5 amino acid substitutions; and
an Rγc ligand comprising an amino acid sequence based on SEQ ID NO: 11 and having from 1 to 5 amino acid substitutions.

### Claim 5 (depends on 1)

The IL-7Rαγc ligand of claim 1, wherein each of the IL-7Rα ligand and the Rγc ligand independently comprises from 1 to 6 glycines (G) on the N-terminus, on the C-terminus, or on both the N-terminus and the C-terminus.

### Claim 6 (depends on 1)

The IL-7Rαγc ligand of claim 1, wherein the IL-7Rα ligand and the Rγc ligand are bound together through a ligand linker.

### Claim 7 (depends on 6)

The IL-7Rαγc ligand of claim 6, wherein the ligand linker comprises an amino acid sequence selected from any one of SEQ ID NO: 113-136.

### Claim 8 (depends on 1)

The IL-7Rαγc ligand of claim 1, wherein the IL-7Rαγc ligand comprises:
an amino acid sequence of any one of SEQ ID NO: 21-26 or an amino acid sequence having greater than 70% sequence similarity to any one of SEQ ID NO: 21-26:
WGIPWCTLDPGSLQCAWLGKH-X1-VVCQDWEGVELCWQ (SEQ ID NO: 21)
GWGIPWCTLDPGSLQCAWLGKH-X1-VVCQDWEGVELCWQ (SEQ ID NO: 22)
WGIPWCTLDPGSLQCAWLGKH-X1-VVCQDWEGVELCWQGG (SEQ ID NO: 23)
GWGIPWCTLDPGSLQCAWLGKH-X1-VVCQDWEGVELCWQGG (SEQ ID NO: 24)
GGWGIPWCTLDPGSLQCAWLGKH-X1-VVCQDWEGVELCWQGG (SEQ ID NO: 25)
GGGWGIPWCTLDPGSLQCAWLGKH-X1-VVCQDWEGVELCWQGG (SEQ ID NO: 26);
and wherein X1 is selected from an amino acid sequence of any one of SEQ ID NO: 101-143.

### Claim 9 (depends on 8)

The IL-7Rαγc ligand of claim 8, wherein X1 is selected from of any one of SEQ ID NO: 137-143.

### Claim 10 (depends on 8)

The IL-7Rαγc ligand of claim 8, wherein X1 has an amino acid sequence of SEQ ID NO: 139.

### Claim 11 (depends on 1)

The IL-7Rαγc ligand of claim 1, wherein the IL-7Rαγc ligand comprises an amino acid sequence of any one of SEQ ID NO: 27-32, or an amino acid sequence having greater than 70% sequence similarity to any one of SEQ ID NO: 27-32.

### Claim 12 (depends on 1)

The IL-7Rαγc ligand of claim 1, wherein the IL-7Rαγc ligand comprises an amino acid sequence of SEQ ID NO: 32 or an amino acid sequence having greater than 70% sequence similarity to SEQ ID NO: 32.

### Claim 13 (depends on 1)

An IL-7Rαγc IgG-Fc fusion fragment comprising the IL-7Rαγc ligand of claim 1 bound to an IgG-Fc fragment.

### Claim 14 (depends on 13)

The IL-7Rαγc IgG-Fc fusion fragment of claim 13, wherein the IgG-Fc fragment is selected from an IgG1-Fc fragment, an IgG2-Fc fragment, and an IgG4-Fc fragment.

### Claim 15 (depends on 13)

The IL-7Rαγc IgG-Fc fusion fragment of claim 13, wherein the IgG-Fc fragment is an IgG2-Fc fragment.

### Claim 16 (depends on 13)

The IL-7Rαγc IgG-Fc fusion fragment of claim 13, wherein the IL-7Rαγc ligand is bound to the IgG-Fc fragment through an IgG-Fc linker.

### Claim 17 (depends on 16)

The IL-7Rαγc IgG-Fc fusion fragment of claim 16, wherein the IgG-Fc linker comprises an amino acid sequence of any one of SEQ ID NO: 150-179.

### Claim 18 (depends on 16)

The IL-7Rαγc IgG-Fc fusion fragment of claim 16, wherein the IgG-Fc linker comprises an amino acid sequence of SEQ ID NO: 163.

### Claim 19 (depends on 13)

The IL-7Rαγc IgG-Fc fusion fragment of claim 13, wherein the IL-7Rαγc IgG-Fc fusion fragment comprises an amino acid sequence having greater than 70% sequence similarity to any one of SEQ ID NO: 44-55.

### Claim 20 (depends on 13)

The IL-7Rαγc IgG-Fc fusion fragment of claim 13, wherein the IL-7Rαγc IgG-Fc fusion fragment comprises an amino acid sequence of any one of SEQ ID NO: 44-55.

### Claim 21 (depends on 13)

The IL-7Rαγc IgG-Fc fusion fragment of claim 13, wherein the IL-7Rαγc IgG-Fc fusion fragment comprises an amino acid sequence having greater than 70% sequence similarity to SEQ ID NO: 45.

### Claim 22 (depends on 13)

The IL-7Rαγc IgG-Fc fusion fragment of claim 13, wherein the IL-7Rαγc IgG-Fc fusion fragment comprises an amino acid sequence having SEQ ID NO: 45.

### Claim 23 (depends on 13)

An IL-7Rαγc IgG-Fc fusion protein comprising:
a first IL-7Rαγc IgG-Fc fusion fragment of claim 13; and
a second IL-7Rαγc IgG-Fc fusion fragment of claim 13,
wherein the IgG-Fc of the first IL-7Rαγc IgG-Fc fusion fragment comprises a first hinge region; wherein the IgG-Fc of the second IL-7Rαγc IgG-Fc fusion fragment comprises a second hinge region; and
wherein the first IL-7Rαγc IgG-Fc fusion fragment and the second first IL-7Rαγc IgG-Fc fusion fragment are bound to each other at the first hinge region and the second hinge region through disulfide bonds.

### Claim 24 (depends on 23)

The IL-7Rαγc IgG-Fc fusion protein of claim 23, wherein the first IL-7Rαγc IgG-Fc fusion fragment and the second IL-7Rαγc IgG-Fc fusion fragment have the same amino acid sequence.

### Claim 25 (depends on 23)

The IL-7Rαγc IgG-Fc fusion protein of claim 23, wherein the first IL-7Rαγc IgG-Fc fusion fragment and the second IL-7Rαγc IgG-Fc fusion fragment comprise different amino acid sequences.

### Claim 26 (depends on 23)

The IL-7Rαγc IgG-Fc fusion protein of claim 23, wherein the first IL-7Rαγc IgG-Fc fusion fragment and the second IL-7Rαγc IgG-Fc fusion fragment comprise a different IL-7Rα ligand.

### Claim 27 (depends on 23)

The IL-7Rαγc IgG-Fc fusion protein of claim 23, wherein the first IL-7Rαγc IgG-Fc fusion fragment and the second IL-7Rαγc IgG-Fc fusion fragment comprise a different Rγc ligand.

### Claim 28 (depends on 1)

A pharmaceutical composition comprising the IL-7Rαγc ligand of claim 1.

### Claim 29 (depends on 13)

A pharmaceutical composition comprising the IL-7Rαγc IgG-Fc fusion protein of claim 13.