# US 12,005,086 B2 · Microbiome related immunotherapies

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- Number: US 12,005,086 B2
- Document ID: US12005086B2
- Status: Granted
- Kind: B2
- Application number: 16/970,532
- Filed: 2019-02-22
- Published: 2020-12-31
- Granted: 2024-06-11
- Earliest claimed: 2018-02-23
- Assignees: Finch Therapeutics Holdings LLC
- Applicants: Finch Therapeutics Holdings LLC
- Inventors: Joseph Lobacki; Ulrich Thienel; Zain Kassam; Marina Santiago
- Web page: https://patentgrep.com/patent/US12005086B2

## CPC

- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 9/5026: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/5047: {Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose}
- A61K 31/506: not condensed and containing further heterocyclic rings
- 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 31/7076: containing purines, e.g. adenosine, adenylic acid
- A61K 35/37: Digestive system
- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/12: Antidiarrhoeals
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 35/04: specific for metastasis
- C07K 16/2818: {against CD28 or CD152}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention generally relates to therapeutic compositions and methods for treating cancer patients. The compositions and methods can increase efficacy of an anti-cancer therapy, or treat, prevent, or inhibit an oncology-treatment induced condition (OTIC) induced by an anti-cancer therapy. The therapeutic compositions comprise microbial compositions and, optionally, an anti-cancer therapeutic agent. The methods comprise administering a therapeutic composition comprising a microbial composition and administering an anti-cancer therapy.

## Claims

### Claim 1

A method for increasing efficacy of an anti-cancer therapy administered to a subject having a cancer, the method comprising orally administering to the subject a therapeutic composition comprising a microbial preparation, wherein the microbial preparation comprises a non-selected community of fecal bacteria harvested from a stool of a healthy human donor, and wherein the non-selected community of fecal bacteria is lyophilized.

### Claim 2 (depends on 1)

The method of claim 1, wherein the anti-cancer therapy comprises surgery, radiation therapy, a chemotherapeutic agent, stem-cell transplant therapy, targeted therapy, or a combination thereof.

### Claim 3 (depends on 2)

The method of claim 2, wherein the anti-cancer therapy is targeted therapy, and wherein the targeted therapy comprises a checkpoint inhibitor.

### Claim 4 (depends on 3)

The method of claim 3, wherein the checkpoint inhibitor targets a checkpoint molecule selected from the group consisting of PD-1, PD-L1, PD-L2, ICOS, ICOSL, CTLA-4, and a combination thereof.

### Claim 5 (depends on 4)

The method of claim 4, wherein the checkpoint molecule is PD-L1.

### Claim 6 (depends on 5)

The method of claim 5, wherein the checkpoint inhibitor is atezolizumab.

### Claim 7 (depends on 1)

The method of claim 1, wherein the cancer is selected from the group consisting of urothelial cancer, lung cancer, breast cancer, liver cancer, and a combination thereof.

### Claim 8 (depends on 7)

The method of claim 7, wherein the lung cancer is non-small cell lung cancer.

### Claim 9 (depends on 1)

The method of claim 1, wherein the therapeutic composition comprises a capsule encapsulating the microbial preparation.

### Claim 10 (depends on 1)

The method of claim 1, wherein the community of fecal bacteria is in the form of a substantially complete fecal microbiota from the stool of the donor.

### Claim 11

A method for treating lung cancer in a subject in need thereof, the method comprising: administering a checkpoint inhibitor to the subject; and orally administering to the subject a capsule containing a lyophilized microbial preparation comprising a non-selected community of fecal bacteria harvested from a stool of a healthy human donor.

### Claim 12 (depends on 11)

The method of claim 11, wherein the checkpoint inhibitor targets a checkpoint molecule selected from the group consisting of PD-1, PD-L1, PD-L2, ICOS, ICOSL, CTLA-4, and a combination thereof.

### Claim 13 (depends on 12)

The method of claim 12, wherein the checkpoint molecule is PD-L1.

### Claim 14 (depends on 11)

The method of claim 11, wherein lyophilized microbial preparation further comprises a cryoprotectant.

### Claim 15 (depends on 1)

The method of claim 1, wherein the cancer is lung cancer.

### Claim 16 (depends on 1)

The method of claim 1, wherein the microbial preparation further comprises a cryoprotectant.

### Claim 17 (depends on 16)

The method of claim 16, wherein the cryoprotectant comprises trehalose.

### Claim 18 (depends on 16)

The method of claim 16, wherein the cryoprotectant comprises sucrose.

### Claim 19 (depends on 1)

The method of claim 1, wherein the anti-cancer therapy is targeted therapy.

### Claim 20 (depends on 9)

The method of claim 9, wherein the subject is administered a plurality of capsules.