# US 12,589,123 B2 · Compositions and methods comprising clostridium butyricum for the treatment of cancer

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- Number: US 12,589,123 B2
- Document ID: US12589123B2
- Status: Granted
- Kind: B2
- Application number: 17/996,779
- Filed: 2021-04-20
- Published: 2023-05-18
- Granted: 2026-03-31
- Earliest claimed: 2020-04-21
- Assignees: City of Hope
- Applicants: City of Hope
- Inventors: Peter P. Lee; Sumanta Kumar Pal
- Web page: https://patentgrep.com/patent/US12589123B2

## CPC

- A61K 35/742: Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
- 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
- A61P 35/00: Antineoplastic agents
- A61K 2039/505: {comprising antibodies}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- C07K 16/2818: {against CD28 or CD152}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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

Provided herein, inter alia, are methods and compositions for the treatment of cancer. The compositions include one or more anti-cancer agents and Clostridium butyricum. Administration of Clostridium butyricum can enhance the therapeutic effects of anti-cancer agents, thereby increasing the efficacy of said agents for cancer treatment.

## Claims

### Claim 1

A method for treating cancer in a subject in need thereof, said method comprising administering to said subject a therapeutically effective amount of an anti-cancer agent and a Clostridium butyricum live biotherapeutic product but without another live biotherapeutic product.

### Claim 2 (depends on 1)

The method of claim 1, wherein said Clostridium butyricum live biotherapeutic product is Clostridium butyricum MIYAIRI 588 live biotherapeutic product (CBM588 LBP).

### Claim 3 (depends on 1)

The method of claim 1, wherein the anti-cancer agent is a checkpoint inhibitor.

### Claim 4 (depends on 3)

The method of claim 3, wherein the checkpoint inhibitor is a PD-1, PD-L1 or CTLA-4 inhibitor.

### Claim 5 (depends on 3)

The method of claim 3, wherein said checkpoint inhibitor is nivolumab, ipilimumab, pembrolizumab, cemiplimab, durvalumab, daclizumab, avelumab, or atezolizumab.

### Claim 6 (depends on 1)

The method of claim 1, further comprising administering a second anticancer agent.

### Claim 7 (depends on 6)

The method of claim 6, wherein said second anti-cancer agent is a second checkpoint inhibitor.

### Claim 8 (depends on 1)

The method of claim 1, wherein said cancer is a microsatellite-instability high (MSI-H) cancer.

### Claim 9 (depends on 1)

The method of claim 1, wherein said cancer is metastatic renal cell carcinoma (mRCC), non-small cell lung cancer, melanoma, sarcoma, lymphoma, breast cancer, bladder cancer, cervical cancer, colon cancer, head and neck cancer, liver cancer, stomach cancer, or rectal cancer.

### Claim 10 (depends on 1)

The method of claim 1, comprising administering said anti-cancer agent in a first dosage form and said Clostridium butyricum live biotherapeutic product in a second dosage form.

### Claim 11 (depends on 10)

The method of claim 10, wherein said anti-cancer agent is at a dosage below its therapeutically effective amount when used in the absence of said Clostridium butyricum live biotherapeutic product for treating cancer.

### Claim 12 (depends on 1)

The method of claim 1, comprising administering to said subject a therapeutically effective amount of (1) a PD-1 inhibitor or a PD-L1 inhibitor; (2) a CTLA-4 inhibitor; and (3) a Clostridium butyricum live biotherapeutic product.

### Claim 13 (depends on 12)

The method of claim 12, comprising administering to said subject a therapeutically effective amount of (1) nivolumab; (2) ipilimumab; and (3) a Clostridium butyricum live biotherapeutic product.

### Claim 14 (depends on 13)

The method of claim 13, wherein said Clostridium butyricum live biotherapeutic product is Clostridium butyricum MIYAIRI 588 live biotherapeutic product (CBM588 LBP).

### Claim 15 (depends on 14)

The method of claim 14, wherein said cancer is metastatic renal cell carcinoma (mRCC).