# US 11,110,168 B2 · Nanoparticles, controlled-release dosage forms, and methods for delivering an immunotherapeutic agent

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- Number: US 11,110,168 B2
- Document ID: US11110168B2
- Status: Granted
- Kind: B2
- Application number: 16/085,015
- Filed: 2017-03-15
- Published: 2019-02-21
- Granted: 2021-09-07
- Earliest claimed: 2016-03-15
- Assignees: North Carolina State University
- Applicants: North Carolina State University
- Inventors: Zhen Gu; Chao Wang; Yanqi Ye
- Web page: https://patentgrep.com/patent/US11110168B2

## CPC

- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 9/513: {Organic macromolecular compounds; Dendrimers}
- A61K 39/39541: {against normal tissues, cells}
- A61K 47/55: the modifying agent being also a pharmacologically or therapeutically active agent, i.e. the entire conjugate being a codrug
- A61K 47/6949: {inclusion complexes, e.g. clathrates, cavitates or fullerenes}
- A61P 35/00: Antineoplastic agents
- C07K 16/2818: {against CD28 or CD152}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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
- 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)

## Abstract

The present disclosure relates to nanoparticles, controlled-release dosage forms, and methods for the administration of an immunotherapeutic agent.

## Claims

### Claim 1

A controlled-release pharmaceutical dosage form comprising:
a CpG oligodeoxynucleotide nano-cocoon, wherein the nano-cocoon comprises an immunotherapeutic agent and inflammation-responsive nanoparticles, wherein the nanoparticles encapsulate a restriction enzyme, wherein the inflammation-responsive nanoparticles comprise triglycerol monostearate (TGMS), and wherein the restriction enzyme is HhaI, and wherein the immunotherapeutic agent is selected from an anti-PD1 antibody, an anti-PDL1 antibody, an anti-CTLA4 antibody, or a combination thereof.

### Claim 2 (depends on 1)

The dosage form of claim 1, wherein the immunotherapeutic agent is an anti-PD1 antibody.

### Claim 3 (depends on 2)

The dosage form of claim 2, wherein the anti-PD1 antibody is nivolumab.

### Claim 4 (depends on 2)

The dosage form of claim 2, wherein the anti-PD1 antibody is pembrolizumab.

### Claim 5 (depends on 1)

The dosage form of claim 1, wherein the immunotherapeutic agent is an anti-CTLA4 antibody.

### Claim 6 (depends on 5)

The dosage form of claim 5, wherein the anti-CTLA4 antibody is ipilimumab.

### Claim 7 (depends on 1)

The dosage form of claim 1, wherein the immunotherapeutic agent is an anti-PD1 antibody in combination with an anti-CTLA4 antibody.