# US 10,478,491 B2 · Methods for enhancing the efficacy of a tumor-directed immune response

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- Number: US 10,478,491 B2
- Document ID: US10478491B2
- Status: Granted
- Kind: B2
- Application number: 15/300,614
- Filed: 2015-04-02
- Published: 2017-06-29
- Granted: 2019-11-19
- Earliest claimed: 2014-04-03
- Assignees: Augusta University Research Institute, Inc.
- Applicants: Augusta University Research Institute, Inc.
- Inventors: Samir Khleif
- Web page: https://patentgrep.com/patent/US10478491B2

## CPC

- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- 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 39/0011: {Cancer antigens}
- A61K 39/001106: {Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ErbB4}
- A61K 39/001156: {Tyrosinase and tyrosinase related proteinases [TRP-1 or TRP-2]}
- A61K 39/001161: {Caspases}
- A61K 39/001162: {Kinases, e.g. Raf or Src}
- A61K 39/00117: {Mucins, e.g. MUC-1}
- A61K 39/001171: {Gangliosides, e.g. GM2, GD2 or GD3}
- A61K 39/001172: {Sialyl-Thomson-nouvelle antigen [sTn]}
- A61K 39/001176: {Heat shock proteins}
- A61K 39/001181: {Alpha-feto protein}
- A61K 39/001182: {Carcinoembryonic antigen [CEA]}
- A61K 39/001186: {MAGE}
- A61K 39/00119: {Melanoma antigens}
- A61K 39/001191: {Melan-A/MART}
- A61K 39/001194: {Prostate specific antigen [PSA]}
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 37/02: Immunomodulators
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/55511: {Organic adjuvants}
- 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

As described below, the present invention features methods for enhancing the efficacy of a tumor antigen in inducing an anti-cancer immune response in a subject by administering an OX40 agonist and an Indoleamine 2,3-dioxygenase (IDO) inhibitor with the tumor antigen.

## Claims

### Claim 1

A method for enhancing an immune response against a tumor antigen in a subject, the method comprising administering to the subject an OX40 agonist antibody or an antigen-binding fragment thereof, 1-methyltryptophan (1-MT), and an immunogenic composition comprising an HPV antigen, thereby enhancing the subject's immune response against the tumor antigen relative to administration of the immunogenic composition and the OX40 agonist antibody or an antigen-binding fragment thereof.

### Claim 2

A method for delaying or reducing tumor growth in a subject, the method comprising administering to the subject an OX40 agonist antibody or an antigen-binding fragment thereof, 1-methyltryptophan (1-MT) and an immunogenic composition comprising an HPV antigen, thereby delaying or reducing tumor growth in the subject relative to administration of the immunogenic composition and the OX40 agonist antibody or an antigen-binding fragment thereof.

### Claim 3 (depends on 1, 2)

The method of either of claim 1 or 2, wherein the subject has an HPV-associated cancer.