# US 2020/0399628 A1 · Formulations and doses of pegylated uricase

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- Number: US 2020/0399628 A1
- Document ID: US20200399628A1
- Status: Published application
- Kind: A1
- Application number: 16/893,153
- Filed: 2020-06-04
- Published: 2020-12-24
- Earliest claimed: 2019-06-04
- Assignees: Selecta Biosciences, Inc.
- Applicants: Selecta Biosciences, Inc.
- Inventors: Lloyd Johnston; Takashi Kei Kishimoto; Earl Sands; Werner Cautreets
- Web page: https://patentgrep.com/patent/US20200399628A1

## CPC

- C12N 9/96: Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
- A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
- A61K 38/44: Oxidoreductases (1)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/60: the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 19/06: Antigout agents, e.g. antihyperuricemic or uricosuric agents
- C12Y 107/03003: Factor-independent urate hydroxylase (1.7.3.3), i.e. uricase
- G01N 33/62: involving urea
- G01N 33/6854: {Immunoglobulins}
- 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 9/5153: {Polyesters, e.g. poly(lactide-co-glycolide)}
- G01N 2800/107: Crystal induced conditions; Gout
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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
- C12Y: ENZYMES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Provided herein are methods and compositions and kits related to identification and/or treatment of subjects, including subjects with hyperuricemia, gout or a condition associated with gout, and for preventing gout flare.

## Claims

### Claim 1

A method, comprising:
obtaining an anti-uricase antibody level (e.g., a titer) in any one of the subjects provided herein, such as in a sample from the subject, and
assessing the subject for treatment of any one of the conditions provided herein.

### Claim 2 (depends on 1)

The method of claim 1, wherein the method further comprises comparing the anti-uricase antibody level in the subject with a threshold.

### Claim 3 (depends on 1)

The method of claim 1, wherein the method further comprises any one of the treatment methods provided herein.

### Claim 4

(canceled)

### Claim 5

A method, comprising:
concomitantly administering to a subject having an anti-uricase antibody level (e.g., a titer) below a threshold, 1) a composition comprising synthetic nanocarriers comprising an immunosuppressant and 2) a composition comprising uricase.

### Claim 6

(canceled)

### Claim 7 (depends on 5)

The method of claim 5, wherein the administration of the treatment doses and/or frequency is adjusted based on the identification or monitoring.

### Claim 8

(canceled)

### Claim 9

A method, comprising,
identifying a subject as having an anti-uricase antibody level (e.g., titer) below a threshold and treating the subject.

### Claim at position 10

10-13. (canceled)

### Claim 14

A method of preventing gout flare, comprising:
concomitantly administering to a subject having an anti-uricase antibody level (e.g., titer) below a threshold, 1) a composition comprising synthetic nanocarriers comprising an immunosuppressant and 2) a composition comprising uricase, wherein the subject is not administered an additional therapeutic to prevent gout flare concomitantly with the concomitant administration.

### Claim at position 12

15-17. (canceled)

### Claim 18 (depends on 14)

The method of claim 14, wherein the subject is identified as having had or as being expected to have gout flare from treatment with a gout therapy without concomitant administration of an additional therapeutic to prevent gout flare.

### Claim at position 14

19-21. (canceled)

### Claim 22 (depends on 1)

The method of claim 1, wherein the subject has gout or a condition associated with gout.

### Claim 23 (depends on 5)

The method of claim 5, wherein the concomitant administration occurs once or more than once in the subject.

### Claim at position 17

24-27. (canceled)

### Claim 28 (depends on 5)

The method of claim 5, wherein the subject is not administered an additional therapeutic to prevent gout flare concomitantly with each concomitant administration.

### Claim at position 19

29-31. (canceled)

### Claim 32 (depends on 5)

The method of claim 5, wherein the composition comprising synthetic nanocarriers comprising an immunosuppressant is administered at a dose of 0.05-0.5 mg/kg immunosuppressant with each administration.

### Claim 33

(canceled)

### Claim 34 (depends on 5)

The method of claim 5, wherein the composition comprising synthetic nanocarriers comprising an immunosuppressant is administered at a dose of 0.55-6.5 mg/kg with each administration, wherein the dose is given as the mg of the synthetic nanocarriers comprising the immunosuppressant.

### Claim 35

(canceled)

### Claim 36 (depends on 5)

The method of claim 5, wherein the composition comprising uricase is administered at a dose of 0.1-1.2 mg/kg uricase with each administration.

### Claim 37

(canceled)

### Claim 38 (depends on 5)

The method of claim 5, wherein a composition comprising uricase is administered to the subject at least once after the one or more concomitant administrations without an immunosuppressant.

### Claim at position 27

39-48. (canceled)

### Claim 49 (depends on 5)

The method of claim 5, wherein the uricase is pegylated uricase.

### Claim at position 29

50-82. (canceled)

### Claim 83

A method, comprising:
administering to any one of the subjects described herein having an anti-uricase antibody level (e.g., titer) below a threshold, a composition comprising uricase at any one of the doses provided herein and a pharmaceutically acceptable carrier one or more times.

### Claim at position 31

84-96. (canceled)

### Claim 97

A method, comprising
concomitantly administering to a subject having an anti-uricase antibody level (e.g., titer) below a threshold, 1) a composition comprising polymeric synthetic nanocarriers comprising PLA, PLA-PEG, and rapamycin; and 2) a composition comprising uricase, wherein the composition comprising polymeric synthetic nanocarriers comprising PLA, PLA-PEG, and rapamycin is administered at a dose of 0.05 mg/kg-0.3 mg/kg rapamcyin and the dose of the composition comprising uricase is.0.1 mg/kg-0.5 mg/kg.

### Claim at position 33

98-112. (canceled)

### Claim 113

A method, comprising:
concomitantly administering to a subject having an anti-uricase antibody level (e.g., titer) below a threshold, 1) a composition comprising polymeric synthetic nanocarriers comprising rapamycin; and 2) a composition comprising pegsiticase, wherein the composition comprising polymeric synthetic nanocarriers is administered at a dose of 0.05 mg/kg-0.3 mg/kg rapamycin and the dose of the composition comprising pegsiticase is 0.1 mg/kg-0.5 mg/kg pegsiticase.

### Claim at position 35

114-132. (canceled)

### Claim 133 (depends on 5)

The method of claim 5, wherein the threshold is an anti-uricase titer of 1080 or less.

### Claim 134

(canceled)