# US 2020/0390718 A1 · Methods and compositions for attenuated anti-viral transfer vector immune response

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- Number: US 2020/0390718 A1
- Document ID: US20200390718A1
- Status: Published application
- Kind: A1
- Application number: 16/885,758
- Filed: 2020-05-28
- Published: 2020-12-17
- Earliest claimed: 2019-05-28
- Assignees: Selecta Biosciences, Inc.
- Applicants: Selecta Biosciences, Inc.
- Inventors: Takashi Kei Kishimoto; Petr Ilyinskii
- Web page: https://patentgrep.com/patent/US20200390718A1

## CPC

- A61K 9/5153: {Polyesters, e.g. poly(lactide-co-glycolide)}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/1271: Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers (liposomes as conjugates {A61K47/6911})
- A61K 9/5146: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyamines, polyanhydrides}
- A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 48/0083: {characterised by an aspect of the administration regime}
- C12N 15/86: Viral vectors
- C12N 2710/14143: viral genome or elements thereof as genetic vector
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Provided herein are methods and related compositions or kits for administering viral transfer vectors in combination with synthetic nanocarriers comprising an immunosuppressant and a corticosteroid.

## Claims

### Claim 1

A composition comprising:
a viral transfer vector, synthetic nanocarriers comprising an immunosuppressant, and a corticosteroid that is not coupled to a nanocarrier.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the corticosteroid is selected from the group consisting of: bethamethasone, cortisone, dexamethasone, ethamethasoneb, hydrocortisone, methylprednisolone, prednisone, predinisolone, and triamcinolone.

### Claim 3 (depends on 2)

The composition of claim 2, wherein the corticosteroid is dexamethasone.

### Claim at position 4

4-37. (canceled)

### Claim 38 (depends on 1)

The composition of claim 1, wherein the immunosuppressant is an mTOR inhibitor.

### Claim 39 (depends on 1)

The composition of claim 1, wherein the immunosuppressant is a rapalog.

### Claim 40 (depends on 39)

The composition of claim 39, wherein the immunosuppressant is rapamycin.

### Claim 41

(canceled)

### Claim 42

A method comprising:
establishing an anti-viral vector attenuated response in a subject by concomitant administration of synthetic nanocarriers comprising an immunosuppressant, a viral transfer transfer vector, and a corticosteroid that is not coupled to a nanocarrier to the subject.

### Claim 43 (depends on 42)

The method of claim 42, wherein the anti-viral transfer vector attenuated response is an IgG or IgM response against the viral transfer vector.

### Claim 44 (depends on 42)

The method of claim 42, wherein the method further comprises at least one repeat dose of the synthetic nanocarriers comprising an immunosuppressant, the viral transfer vector, and the corticosteroid.

### Claim 45 (depends on 42)

The method of claim 42, wherein the method further comprises at least two repeat doses of the synthetic nanocarriers comprising an immunosuppressant, the viral transfer vector, and the corticosteroid.

### Claim 46 (depends on 42)

The method of claim 42, wherein the anti-viral vector attenuated response is maintained for at least repeat doses of the synthetic nanocarriers comprising an immunosuppressant, the viral transfer vector, and the corticosteroid.

### Claim 47

A method comprising:
escalating transgene expression of a viral transfer vector in a subject by repeatedly, concomitantly administering to the subject synthetic nanocarriers comprising an immunosuppressant, a viral transfer vector, and a corticosteroid that is not coupled to a nanocarrier to the subject.

### Claim 48 (depends on 47)

The method of claim 47, wherein the method comprises at least one, two or three concomitant administrations of the synthetic nanocarriers comprising an immunosuppressant, the viral transfer vector, and the corticosteroid.

### Claim 49 (depends on 47)

The method of claim 47, wherein the escalated transgene expression of the viral transfer vector maintained for at least one, two or three concomitant administrations of the synthetic nanocarriers comprising an immunosuppressant, the viral transfer vector, and the corticosteroid.

### Claim 50 (depends on 42)

The method of claim 42, wherein the corticosteroid is dexamethasone.

### Claim 51 (depends on 42)

The method of claim 42, wherein the viral transfer vector is as defined in any one of the preceding claims.

### Claim 52 (depends on 42)

The method of claim 42, wherein the synthetic nanocarriers are as defined in any one of the preceding claims.

### Claim 53 (depends on 42)

The method of claim 42, wherein the concomitant administration is simultaneous administration.

### Claim at position 21

54-55. (canceled)

### Claim 56 (depends on 1)

A kit comprising the compositions of claim 1 and instructions for use.

### Claim 57 (depends on 1)

A kit comprising a viral transfer vector, synthetic nanocarriers, and a corticosteroid, as defined in claim 1, respectively, and instructions for use.

### Claim 58

(canceled)