# US 2023/0056445 A1 · Polypeptides

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- Number: US 2023/0056445 A1
- Document ID: US20230056445A1
- Status: Published application
- Kind: A1
- Application number: 17/620,030
- Filed: 2020-06-19
- Published: 2023-02-23
- Earliest claimed: 2019-06-21
- Assignees: Sorriso Pharmaceuticals, Inc.
- Applicants: Sorriso Pharmaceuticals, Inc.
- Inventors: Scott CROWE; Mike WEST; Kevin ROBERTS; Tim CARLTON; Luana MAGGIORE; Marion CUBITT; Lurdes DUARTE; Martyn SYMMONS; Keith RAY
- Web page: https://patentgrep.com/patent/US20230056445A1

## CPC

- A61P 37/02: Immunomodulators
- C07K 16/2866: {against receptors for cytokines, lymphokines, interferons}
- C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere}
- 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 2317/22: from camelids, e.g. camel, llama or dromedary
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/569: Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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)
- 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

There are provided inter alia polypeptides capable of inhibiting IL-7 and/or L-TSLP binding to IL-7R (IL-7R), as well as to constructs and pharmaceutical compositions comprising these polypeptides.

## Claims

### Claim 1

A method of treating an autoimmune or inflammatory disease, the method comprising administering to an individual a polypeptide capable of inhibiting IL-7 and/or L-TSLP binding to wherein the polypeptide comprises an immunoglobulin chain variable domain which binds to IL-7Rα comprising a CDR1 comprising the amino acid sequence of SEQ ID NO: 71, or 82 a CDR2 comprising the amino acid sequence of SEQ ID NO: 72, 73, 74, 75, 76, or 83 and a CDR3 comprising the amino acid sequence of SEQ ID NO: 77, 78, or 84, thereby treating the autoimmune or inflammatory disease.

### Claim 2

The polypeptide according to clause 1, wherein the polypeptide is capable of inhibiting IL-7 binding to IL-7R.

### Claim 3

The polypeptide according to clause 1, wherein the polypeptide is capable of inhibiting L-TSLP binding to IL-7R.

### Claim 4

(canceled)

### Claim 5

(canceled)

### Claim 6

(canceled)

### Claim 7 (depends on 1)

The polypeptide according to claim 1, wherein CDR1 comprises or consists of SEQ ID NO: 1 or SEQ ID NO: 71, CDR2 comprises or consists of SEQ ID NO: 2, SEQ ID NO: 72, SEQ ID NO: 73, SEQ ID NO: 74, SEQ ID NO: 75 or SEQ ID NO: 76 and CDR3 comprises or consists of SEQ ID NO: 3, SEQ ID NO: 77 or SEQ ID NO: 78.

### Claim 8 (depends on 1)

The polypeptide according to claim 1 wherein CDR1 comprises or consists of SEQ ID NO: 1, CDR2 comprises or consists of SEQ ID NO: 2 and CDR3 comprises or consists of SEQ ID NO: 3.

### Claim 9 (depends on 1)

The polypeptide according to claim 1 wherein the polypeptide comprises sharing 90% or greater sequence identity with SEQ ID NO: 8.

### Claim 10 (depends on 9)

The polypeptide according to claim 9, wherein the polypeptide comprises SEQ ID NO: 8.

### Claim 11

(canceled)

### Claim 12 (depends on 1)

The polypeptide according to claim 1 wherein the polypeptide binds to an amino acid of IL-7Rα selected from the list consisting of Glu27, Ser31, Leu57, Val58, Glu59, Lys77, Lys78, Phe79, Leu80, Leu81, Ile82, Thr104, Lys137, Lys138, Tyr139, Lys141, His191, Tyr192 and Phe193.

### Claim 13

(canceled)

### Claim 14

(canceled)

### Claim 15

(canceled)

### Claim 16 (depends on 1)

The polypeptide according to claim 1, wherein the polypeptide is a VHH.

### Claim 17

(canceled)

### Claim 18 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)

The polypeptide or construct according to any one of claims 1 to 17, wherein the polypeptide neutralizes IL-7R binding to IL-7 with an EC50 of 2.00 nM or less.

### Claim 19 (depends on 1)

The polypeptide or construct according to claim 1 wherein the polypeptide binds to IL-7Rα with an equilibrium dissociation constant (Kd) of 10−7 M or less.

### Claim 20 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)

The polypeptide according to any one of claims 1 to 19, which is substantially resistant to trypsin and chymotrypsin.

### Claim 21 (depends on 1)

A pharmaceutical composition comprising the polypeptide or construct according to claim 1 and one or more pharmaceutically acceptable diluents or carriers.

### Claim at position 22

-26. (canceled)

### Claim 27 (depends on 1)

The method according to claim 1, wherein the autoimmune and/or inflammatory disease is Crohn's disease or ulcerative colitis.

### Claim 28 (depends on 1)

The method according to claim 1, wherein the autoimmune and/or inflammatory disease is atopic dermatitis.

### Claim 29 (depends on 1)

The method according to claim 1, wherein the polypeptide is formulated for use in oral administration.

### Claim 30 (depends on 1)

The polypeptide for use, pharmaceutical composition for use, construct for use, method according to claim 1, wherein the polypeptide is formulated for use in topical administration.

### Claim 31 (depends on 1)

A polynucleotide encoding the polypeptide claim 1.

### Claim 32 (depends on 31)

The polynucleotide according to claim 31, wherein the polynucleotide comprises or consists of SEQ ID NO: 70.

### Claim 33 (depends on 1)

The method of claim 1, wherein the autoimmune and/or inflammatory disease is asthma.