# US 11,298,380 B2 · IPSC-based vaccine as a prophylactic and therapeutic treatment for cancer

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- Number: US 11,298,380 B2
- Document ID: US11298380B2
- Status: Granted
- Kind: B2
- Application number: 16/237,705
- Filed: 2019-01-01
- Published: 2019-09-26
- Granted: 2022-04-12
- Earliest claimed: 2018-01-02
- Assignees: Khloris Biosciences, Inc.; The Board of Trustees of the Leland Stanford Junior University
- Applicants: Khloris Biosciences, Inc.; The Board of Trustees of the Leland Stanford Junior University
- Inventors: Nigel G. Kooreman; Joseph C. Wu; Lynne A. Bui
- Web page: https://patentgrep.com/patent/US11298380B2

## CPC

- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 35/33: Fibroblasts
- A61K 39/0005: {Vertebrate antigens (from snakes A61K39/38)}
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 35/00: Antineoplastic agents
- A61K 2039/55516: {Proteins; Peptides}
- A61K 2039/55561: {CpG containing adjuvants; Oligonucleotide containing adjuvants}
- A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A}
- A61K 2039/55577: {Saponins; Quil A; QS21; ISCOMS}
- A61K 2039/585: {wherein the target is cancer}
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

In one embodiment, the application discloses a method for the treatment of cancer in a patient, the method comprises a vaccination of the patient with a vaccine, wherein the vaccine comprises an effective amount of mammalian pluripotent stem cells obtained from an embryonic source or obtained by reprogramming of somatic cells from the patient, wherein the vaccination comprising the step of administering a mammalian pluripotent stem cells to the patient in need thereof; and vaccine formulations for use in the treatment of cancer.

## Claims

### Claim 1

A method for the treatment of cancer in a patient, the method comprises a vaccination of the patient with a vaccine, wherein the vaccine comprises an effective amount of mammalian pluripotent stem cells obtained by reprogramming of somatic cells from the patient and the vaccine further comprises an adjuvant that is an immunological agent to boost the immune response towards the vaccine and, wherein the vaccination comprising the step of administering mammalian pluripotent stem cells to the patient in need thereof.

### Claim 2 (depends on 1)

The method of claim 1 wherein the pluripotent stem cells are induced pluripotent stem cells (iPSCs).

### Claim 3 (depends on 1)

The method of claim 1, wherein the mammalian pluripotent stem cells are undifferentiated pluripotent stem cells.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pluripotent stem cells are generated using a mini-intronic plasmid containing four reprogramming factors comprising Oct4, c-Myc, KLF-4 and Sox2, with the possible addition of shRNA p53.

### Claim 5 (depends on 1)

The method of claim 1, wherein the stem cells are obtained by reprogramming somatic cells selected from the group consisting of fibroblast, keratinocytes, peripheral blood cells and renal epithelial cells.

### Claim 6 (depends on 1)

The method of claim 1, wherein the vaccine is administered according to at least one of the following methods: a) as a standalone vaccination; b) as an adjuvant therapy before tumor resection; c) as an adjuvant therapy after tumor resection, d) in a metastatic setting; e) as a preventative setting in the absence of tumor or cancer; and f) in combination with chemotherapy, immunotherapy, targeted therapies, using biologic agents, using small molecule agents, with nanoparticles comprising the biologic or small molecule agents, or a combination thereof.

### Claim 7 (depends on 1)

The method of claim 1, wherein the cancer is selected from the group consisting of breast cancer, melanoma and mesothelioma.

### Claim 8 (depends on 1)

The method of claim 1, wherein the cancer is selected from the group consisting of leukemia, multiple myeloma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, lymphoma, myeloproliferative disorders, squamous cell cancer, adenocarcinoma, sarcoma, neuroendocrine carcinoma, bladder cancer, skin cancer, brain and spinal cord cancers, head and neck cancer, thyroid, bone cancer, breast cancer, cervical cancer, colorectal cancer, endometrial cancer, gastrointestinal cancers, (hypo) laryngeal cancer, esophageal cancer, liver cancer, lung cancer, pancreatic cancer, prostate cancer, eye cancer, renal cell cancer, kidney, hepatic, ovarian cancer, gastric cancer, testicular cancer, thyroid and thymus cancer.

### Claim 9

A method for the vaccination of a mammal with a pluripotent stem cell cancer vaccine, the method comprising:
introducing the mammalian pluripotent stem cells obtained by reprogramming from a somatic cell from the recipient, wherein the vaccine further comprises an adjuvant where the adjuvant is an immunological agent to boost the immune response towards the vaccine; and
providing the recipient with the vaccine.

### Claim 10 (depends on 9)

The method of claim 9, wherein the mammalian cells are undifferentiated pluripotent cells.

### Claim 11 (depends on 10)

The method of claim 10, wherein the pluripotent stem cells are generated using a mini-intronic plasmid containing four reprogramming factors comprising Oct4, c-Myc, KLF-4 and Sox2.

### Claim 12 (depends on 9)

The method of claim 9, wherein the pluripotent stem cells are obtained by reprogramming somatic cells selected from the group consisting of fibroblast, keratinocytes, peripheral blood cells and renal epithelial cells.

### Claim 13 (depends on 9)

The method of claim 9, wherein the vaccine is irradiated prior to vaccination.

### Claim 14

A thermally stable vaccine composition comprising an effective amount of mammalian pluripotent stem cells obtained by reprogramming of somatic cells from a mammal, and an adjuvant or an immunological agent to boost the immune response towards the vaccine.

### Claim 15 (depends on 14)

The vaccine composition of claim 14, wherein the pluripotent stem cells are induced pluripotent stem cells (iPSCs).

### Claim 16 (depends on 14)

The vaccine composition of claim 14, wherein the mammalian pluripotent stem cells are undifferentiated pluripotent stem cells.

### Claim 17 (depends on 14)

The vaccine composition of claim 14, wherein the stem cells are obtained by reprogramming somatic cells selected from the group consisting of fibroblast, keratinocytes, peripheral blood cells and renal epithelial cells.

### Claim 18 (depends on 14)

The vaccine composition of claim 14, wherein the adjuvant is selected from the group consisting of CpG, QS21, poly(di(carboxylatophenoxy)phosphazene; derivatives of lipopolysaccharides such as monophosphoryl lipid A, muramyl dipeptide (MDP; Ribi), threonyl-muramyl dipeptide (t-MDP; Ribi); OM-174; cholera toxin (CT), and Leishmania elongation factor.