# US 11,110,171 B2 · PD-1 related cancer therapy

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- Number: US 11,110,171 B2
- Document ID: US11110171B2
- Status: Granted
- Kind: B2
- Application number: 16/956,451
- Filed: 2018-12-21
- Published: 2020-10-22
- Granted: 2021-09-07
- Earliest claimed: 2017-12-21
- Assignees: New York University
- Applicants: New York University
- Inventors: Adam Mor; Ben Neel
- Web page: https://patentgrep.com/patent/US11110171B2

## CPC

- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)}
- A61K 31/343: condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
- A61K 31/404: Indoles, e.g. pindolol
- A61K 31/4412: having oxo groups directly attached to the heterocyclic ring
- A61K 31/4535: containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
- A61K 31/454: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
- A61K 31/47: Quinolines; Isoquinolines
- A61K 31/4704: 2-Quinolinones, e.g. carbostyril
- A61K 31/497: containing further heterocyclic rings
- A61K 31/7105: Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
- A61K 31/713: Double-stranded nucleic acids or oligonucleotides
- A61K 38/465: {acting on ester bonds (3.1), e.g. lipases, ribonucleases}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 35/00: Antineoplastic agents
- C07K 14/4747: {Apoptosis related proteins}
- C07K 14/70521: {CD28, CD152}
- C07K 16/2803: {against the immunoglobulin superfamily}
- C12N 15/113: Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; {Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing (when used in plants C12N15/8218)}
- C12N 15/1137: {against enzymes (viral enzymes C12N15/1131; receptors C12N15/1138)}
- G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites}
- G01N 33/6848: {Methods of protein analysis involving mass spectrometry}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- 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)
- C12N 2310/14: interfering nucleic acids [NA]
- C12N 2320/31: Combination therapy
- G01N 2333/705: Assays involving receptors, cell surface antigens or cell surface determinants
- G01N 2560/00: Chemical aspects of mass spectrometric analysis of biological material
- G01N 2800/24: Immunology or allergic disorders
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- 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)
- 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)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Provided are compositions and methods for identifying individuals with cancer who will benefit from PD-1 inhibitor therapy. The method comprises determining levels of signaling lymphocyte activation molecule-associated protein (SAP) in an individual and based on the SAP levels, determining if the individual is suitable for PD-1 inhibitor therapy. Also provided is a method of treatment of X-linked lymphoproliferative disease comprising administering to an individual PD-1 inhibitory therapy, with or without SHP2 inhibitors.

## Claims

### Claim 1

A method of treating an individual afflicted with cancer comprising:
in a sample of blood cells obtained from the individual determining a level of signaling lymphocyte activation molecule-associated protein (SAP) to be lower than a reference SAP level, wherein the reference SAP level is the level of SAP from an individual or individuals without cancer; and administering to the individual afflicted with cancer a therapy comprising PD-1 inhibition therapy, and further comprising administering to the individual a SHP2 inhibitor.

### Claim 2 (depends on 1)

The method of claim 1, wherein the SHP2 inhibitor is TNO155, 1-4-6-bromonaphthalen-2-yl) thiazol-2-yl)-4-methylpiperidin-4-amine, NSC-117199, NSC-87877, SPI-112, SPI-112Me, Fumosorinone, demethylincisterol A3, 11a-1, Cryptotanshinone, siRNA, shRNA, CRISPR/Cas9 or other gene expression disrupter of PTPN11.

### Claim 3 (depends on 1)

The method of claim 1, wherein cancer is melanoma, lung cancer, kidney cancer, bladder cancer, head and neck cancer, Hodgkin's lymphoma, or urinary tract cancer.

### Claim 4 (depends on 1)

The method of claim 1, wherein the PD-1 inhibition therapy comprises administration of one or more of the following: pembrolizumab, nivolumab, atezolizumab, avelumab, and durvalumab.

### Claim 5 (depends on 1)

The method of claim 1, wherein the blood cells are peripheral blood cells or peripheral T cells.
