Use of bacteria, bacterial products, and other immunoregulatory entities in combination with anti-ctla-4 and/or anti-pd-1 antibodies to treat solid tumor malignancies

Patent metadata

Field	Value
Publication number	US-2025381235-A1
Application number	US-202519317052-A
Country	US
Kind code	A1
Filing date	Sep 2, 2025
Priority date	Mar 31, 2014
Publication date	Dec 18, 2025
Grant date	—

Abstract

The presently disclosed subject matter provides methods and kits for treating solid tumors in a subject by using a combination of anti-CTLA-4 and/or anti-PD-1 antibodies with at least one member of the group consisting of a bacterium, bacterial product, and an immunoregulatory entity. In particular embodiments, the bacteria are toxin-depleted, anaerobic bacteria, such as Clostridium novyi -NT.

First claim

What is claimed is:

1 . A method of treating a solid colon tumor in a subject, the method comprising administering to the subject a therapeutically effective amount of a combination of an anti-CTLA-4 antibody and an anti-PD-1 antibody to treat the solid colon tumor.

2 . The method of claim 1 , wherein the combination of the anti-CTLA-4 antibody and anti-PD-1 antibody is administered by at least one method selected from the group consisting of intravenously, intramuscularly, subcutaneously, and intratumorally.

3 . The method of claim 1 , wherein the subject is human.

4 . The method of claim 1 , wherein the subject is a non-human animal.

5 . A kit for treating a solid colon tumor in a subject, the kit comprising a therapeutically effective amount of an anti-CTLA-4 antibody, and one or more Clostridium novyi bacterium spores.

6 . The kit of claim 5 , wherein the Clostridium novyi bacterium spores are toxin-depleted and anaerobic.

7 . The kit of claim 6 , wherein the Clostridium novyi bacterium spores are Clostridium novyi -NT bacterium spores.

8 . The kit of claim 6 , wherein part of or all of a toxin gene of a wild-type form of the Clostridium novyi bacterium spores is deleted.

9 . The kit of claim 6 , wherein the toxicity of the Clostridium novyi bacterium spores is reduced by a factor of at least 2 compared to a corresponding wild-type Clostridium novyi bacterium spores.

10 . The kit of claim 5 , wherein the Clostridium novyi bacterium spores are formulated to be administered intravenously or intratumorally.

11 . The kit of claim 5 , wherein the anti-CTLA-4 antibody is formulated to be administered by at least one method selected from the group consisting of intravenously, intramuscularly, subcutaneously, and intratumorally.

12 . The kit of claim 5 , wherein the solid colon tumor is malignant.

13 . The kit of claim 5 , wherein the subject is human.

14 . The kit of claim 5 , wherein the subject is a non-human animal.

Assignees

• Univ Johns Hopkins
• Biomed Valley Discoveries Inc

Inventors

• Zhou Shibin
• Vogelstein Bert
• Kinzler Kenneth
• Kim Kibem
• Saha Saurabh

Classifications

• C07K16/2803

  against the immunoglobulin superfamily · CPC title

• A61K2039/54

  characterised by the route of administration · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• A61K2035/115

  Probiotics · CPC title

• A61K39/3955

  against proteinaceous materials, e.g. enzymes, hormones, lymphokines · CPC title