# US 2021/0277085 A1 · Targeted immunotolerance

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- Number: US 2021/0277085 A1
- Document ID: US20210277085A1
- Status: Published application
- Kind: A1
- Application number: 17/053,979
- Filed: 2018-11-20
- Published: 2021-09-09
- Earliest claimed: 2017-05-24
- Assignees: Pandion Therapeutics, 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/US20210277085A1

## CPC

- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- C07K 14/70532: {B7 molecules, e.g. CD80, CD86}
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/12: Antivirals
- C07K 14/55: IL-2
- C07K 16/2803: {against the immunoglobulin superfamily}
- C07K 16/2818: {against CD28 or CD152}
- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- C07K 16/2833: {against MHC-molecules, e.g. HLA-molecules}
- 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}
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- C07K 2317/21: from primates, e.g. man
- C07K 2317/31: multispecific
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/524: CH2 domain
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/64: comprising a combination of variable region and constant region components
- C07K 2317/70: characterized by effect upon binding to a cell or to an antigen
- C07K 2317/71: Decreased effector function due to an Fc-modification
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/75: Agonist effect on antigen
- C07K 2319/00: Fusion polypeptide
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C07K 2319/31: fusions, other than Fc, for prolonged plasma life, e.g. albumin
- C07K 2319/33: fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
- C07K 2319/75: containing a fusion for activation of a cell surface receptor, e.g. thrombopoeitin, NPY and other peptide hormones
- 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

Methods and compounds for conferring site-specific or local immune privilege.

## Claims

### Claim 1

A polypeptide comprising a targeting moiety that binds to a target cell and an effector binding/modulating moiety, wherein the effector binding/modulating moiety is a IL-2 mutein polypeptide (IL-2 mutein), wherein the IL-2 mutein comprises the sequence of SEQ ID NO: 60, wherein at least one of X1, X2, X3, and X4 is I and the remainder are L or I.

### Claim 2 (depends on 1)

The polypeptide of claim 1, wherein the targeting moiety comprises an antibody that binds to a target protein on the surface of a target cell.

### Claim 3 (depends on 1)

The polypeptide of claim 1, wherein the antibody is an antibody that binds to MAdCAM, OAT1, OCT2, FXYD2, TSPAN7, DPP6, HEPACAM2, TMEM27, or GPR119.

### Claim at position 4

4-7. (canceled)

### Claim 8 (depends on 1)

The polypeptide of claim 1, wherein the compound has the formula from N-terminus to C-terminus:
R1-Linker Region A-R2 or R3-Linker Region B-R4,
wherein,
R1, R2, R3, and R4, each independently comprises the effector binding/modulating moiety, the targeting moiety, or is absent.

### Claim 9 (depends on 8)

The polypeptide of claim 8, wherein each of Linker Region A and Linker Region B comprises an Fc region.

### Claim 10 (depends on 9)

The polypeptide of claim 9, wherein one of R1 and R2 is the IL-mutein antibody and one of R1 and R2 is an anti-MAdCAM antibody.

### Claim 11 (depends on 8)

The polypeptide of claim 8, wherein R1 is the IL-mutein and R2 is an anti-MAdCAM antibody.

### Claim 12 (depends on 8)

The polypeptide of claim 8, wherein one of R1 is anti-MAdCAM antibody and one R2 is an anti-PD-1 antibody.

### Claim 13 (depends on 8)

The polypeptide of claim 8, wherein one of R3 and R4 is the IL-2 mutein and one of R3 and R4 is an anti-MAdCAM antibody.

### Claim 14 (depends on 8)

The polypeptide of claim 8, wherein R3 is the IL-2 mutein and R4 is an anti-MAdCAM antibody.

### Claim 15 (depends on 8)

The polypeptide of claim 8, wherein R3 is an anti-MAdCAM antibody and one R4 is the IL-2 mutein.

### Claim 16 (depends on 8)

The polypeptide of claim 8, wherein the linker is absent.

### Claim 17 (depends on 8)

The polypeptide of claim 8, wherein the linker is a Fc region.

### Claim 18 (depends on 8)

The polypeptide of claim 8, wherein the linker is a glycine/serine linker.

### Claim 19

(canceled)

### Claim 20 (depends on 1)

The polypeptide of claim 1, wherein the IL-2 mutein comprises a IL-2 sequence of SEQ ID NO: 6, wherein peptide comprises a mutation at a position that corresponds to position 53, 56, 80, or 118 of SEQ ID NO: 6.

### Claim at position 18

21-41. (canceled)

### Claim 42 (depends on 1)

The polypeptide of claim 1, wherein the polypeptide comprises a first chain and a second chain that form the polypeptide, wherein
the first chain comprises:
VH-Hc-Linker-C1, wherein VH is a variable heavy domain that binds to the target cell with a VL domain of the second chain; He is a heavy chain of antibody comprising CH1-CH2-CH3 domain, the Linker is a glycine/serine linker, and C1 is a IL-2 mutein fused to a Fc protein in either the N-terminal or C-terminal orientation; and
the second chain comprises:
VL-Lc, wherein VL is a variable light chain domain that binds to the target cell with the VH domain of the first chain, and the Lc domain is a light chain CK domain.

### Claim at position 20

43-55. (canceled)

### Claim 56 (depends on 1)

A method of treating a subject with inflammatory bowel disease, the method comprising administering a polypeptide of claim 1 to the subject to treat the inflammatory bowel disease.

### Claim at position 22

57-58. (canceled)

### Claim 59 (depends on 1)

A method of treating a subject with auto-immune hepatitis, the method comprising administering a therapeutic compound of claim 1 to the subject to treat the auto-immune hepatitis.

### Claim at position 24

60-63. (canceled)

### Claim 64 (depends on 1)

A method of treating a subject having, or at risk, or elevated risk, for having, an autoimmune disorder, comprising administering a therapeutically effective amount of a therapeutic compound of claim 1, thereby treating the subject.

### Claim at position 26

65-70. (canceled)

### Claim 71 (depends on 1)

A cell comprising a nucleic acid molecule encoding a therapeutic compound of claim 1.