# US 12,565,682 B2 · Methods of treating cancer

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- Number: US 12,565,682 B2
- Document ID: US12565682B2
- Status: Granted
- Kind: B2
- Application number: 17/780,798
- Filed: 2020-11-25
- Published: 2023-01-26
- Granted: 2026-03-03
- Earliest claimed: 2019-11-27
- Assignees: NantCell, Inc.
- Applicants: Nantcell, Inc.
- Inventors: Sadanand Vodala; Andrew Nguyen; Charles Joseph Vaske; Shahrooz Rabizadeh
- Web page: https://patentgrep.com/patent/US12565682B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/675: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
- A61K 31/7056: containing five-membered rings with nitrogen as a ring hetero atom
- A61K 31/7068: having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K 33/243: Platinum; Compounds thereof
- A61K 35/12: Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00)
- A61K 38/1793: {for cytokines; for lymphokines; for interferons}
- A61K 38/2086: {IL-13 to IL-16}
- A61K 39/0011: {Cancer antigens}
- A61K 39/001164: {GTPases, e.g. Ras or Rho}
- A61K 39/00117: {Mucins, e.g. MUC-1}
- A61K 39/001182: {Carcinoembryonic antigen [CEA]}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/643: {Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]}
- A61P 35/00: Antineoplastic agents
- A61P 37/04: Immunostimulants
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/158: Expression markers
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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

## Abstract

Multimodal cancer immunotherapy is a combination of cancer immunotherapies used to treat cancer in patients. T cell receptor diversity is used as a component of a method to treat cancer involving cancer therapy, including multimodal cancer immunotherapy.

## Claims

### Claim 1

A method of treating cancer in a patient who has been receiving a multimodal cancer immunotherapy for at least two months, the method comprising:
a. calculating T cell receptor (TCR) diversity in a blood sample from the cancer patient before initiation of the multimodal cancer immunotherapy, or at initiation of the multimodal cancer immunotherapy;
b. calculating the TCR diversity in a blood sample from the cancer patient at least two months after initiation of the multimodal cancer immunotherapy to the patient;
c. comparing the TCR diversity from steps a and b; and
d. continuing administration of the multimodal cancer immunotherapy to the patient, if the T cell receptor (TCR) diversity in the blood sample from the patient increases at least three-fold between steps a and b;
wherein
the multimodal cancer immunotherapy comprises an NK cell selected from the group consisting of aNK, haNK, taNK, and t-haNK; or
the multimodal cancer immunotherapy comprises two or more immunotherapies selected from the group consisting of a viral vector expressing an antigen, a yeast immunotherapy, an immune checkpoint inhibitor, and an IL-15 superagonist.

### Claim 2 (depends on 1)

The method of claim 1, wherein the multimodal cancer immunotherapy further comprises an immunotherapy selected from the group consisting of aldoxorubicin, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, NK cells, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, and nab-paclitaxel.

### Claim 3 (depends on 1)

The method of claim 1, wherein the patient is administered at least one cancer therapy that is not an immunotherapy.

### Claim 4 (depends on 1)

The method of claim 1, wherein the cancer is selected from the group consisting of lung cancer, skin cancer, brain cancer, spinal cord cancer, breast cancer, colon cancer, rectal cancer, liver cancer, pancreatic cancer, head and neck cancer, gall bladder cancer, ovarian cancer, urothelial cancer, and blood cancer.

### Claim 5 (depends on 1)

The method of claim 1, wherein the cancer is selected from the group consisting of non-small-cell lung carcinoma (NSCLC), triple negative breast cancer (TNBC), head & neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, chordoma, melanoma, Merkel cell carcinoma, non-Hodgkin lymphoma, acute myelogenous leukemia, myelodysplastic syndrome, neuroblastoma, and glioblastoma.

### Claim 6 (depends on 1)

The method of claim 1, wherein the TCR diversity is calculated as a Shannon Wiener diversity index.

### Claim 7 (depends on 1)

The method of claim 1, wherein the TCR diversity is calculated for CDR3 regions from TCR α/β chains.

### Claim 8 (depends on 1)

The method of claim 1, wherein the TCR diversity is calculated for RNA sequences encoding CDR3 regions from TCR α/β chains.

### Claim 9 (depends on 1)

The method of claim 1, further comprising administering to the patient a cancer therapy selected from the group consisting of stereotactic body radiation therapy (SBRT), a low dose chemotherapy, and a low dose radiation therapy.