# US 11,110,106 B2 · Sting agonists for treating bladder cancer and solid tumors

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- Number: US 11,110,106 B2
- Document ID: US11110106B2
- Status: Granted
- Kind: B2
- Application number: 17/096,416
- Filed: 2020-11-12
- Published: 2021-03-04
- Granted: 2021-09-07
- Earliest claimed: 2018-10-29
- Assignees: Venenum Biodesign, LLC
- Applicants: Venenum Biodesign, LLC; Catherine C. McGuinness
- Inventors: Brian F. McGuinness; Grant Gallagher; Michael S. McQueney; Rukiye Nazan Eraslan; Gary Schieven; Jason Trama; Venugopalareddy Bommireddy Venkata; Axel Metzger; David J. Diller; David E. Kaelin
- Web page: https://patentgrep.com/patent/US11110106B2

## CPC

- A61K 31/688: both hydroxy compounds having nitrogen atoms, e.g. sphingomyelins
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 31/22: for herpes viruses
- A61P 35/00: Antineoplastic agents
- C07F 9/6587: having two phosphorus atoms as ring hetero atoms in the same ring
- C07K 16/2818: {against CD28 or CD152}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- 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
- C07F: ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM (metal-containing porphyrins C07D487/22)
- 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

Methods for treating bladder cancer and solid tumors are disclosed. The methods include administering to a patient a compound of formula 1 Pharmaceutical compositions of compound 1 are also disclosed.

## Claims

### Claim 1

A method for treating bladder cancer comprising administering to a patient in need of treatment for bladder cancer a therapeutically effective amount of a compound of formula 1
or pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

The method of claim 1 wherein said compound of formula 1 is administered as an aqueous solution.

### Claim 3 (depends on 1)

The method of claim 1 wherein said compound of formula 1 is administered intravesically.

### Claim 4 (depends on 1)

The method of claim 1 wherein said bladder cancer is non-muscle-invasive bladder cancer.

### Claim 5 (depends on 1)

The method of claim 1 wherein said bladder cancer is BCG-unresponsive Non-Muscle Invasive bladder cancer.

### Claim 6 (depends on 4)

The method of claim 4 wherein said bladder cancer is Non-Muscle Invasive bladder cancer and said patient exhibits incomplete response to anti-PD1 therapy.

### Claim 7 (depends on 2)

The method of claim 2 wherein said compound is administered in a solution that provides from 1 mg to 100 mg of formula 1 in a single dose.

### Claim 8 (depends on 7)

The method of claim 7 wherein said solution provides from 50 mg to 100 mg of formula 1 in a single dose.

### Claim 9 (depends on 2)

The method of claim 2 wherein said compound is administered in a solution that provides from 50 mg to 500 mg of formula 1 in a single dose.

### Claim 10 (depends on 7)

The method of claim 7 wherein said solution is administered initially as 6 weekly doses.

### Claim 11 (depends on 1)

The method of claim 1 wherein the compound of formula 1 is present as single enantiomer 1C in at least 95% stereochemical purity.

### Claim 12 (depends on 11)

The method of claim 11 wherein the compound is administered intravesically as an aqueous solution.

### Claim 13

A pharmaceutical composition comprising an aqueous carrier and a compound of formula 1
or pharmaceutically acceptable salt thereof.

### Claim 14 (depends on 13)

The composition of claim 13 wherein the compound of formula 1 is present as single enantiomer 1C in at least 95% stereochemical purity.

### Claim 15 (depends on 13)

The pharmaceutical composition of claim 13 wherein said composition is a solution containing the compound of formula 1 in a concentration from 0.1 mg/mL to 136 mg/mL.

### Claim 16 (depends on 13)

The pharmaceutical composition of claim 13 wherein said composition is a solution containing the compound of formula 1 in a concentration from 1 mg/mL to 50mg/mL.

### Claim 17 (depends on 13)

The pharmaceutical composition of claim 13 wherein said composition is a solution containing the compound of formula 1 in a concentration from 1 mg/mL to 10mg/mL.

### Claim 18 (depends on 14)

The pharmaceutical composition of claim 14 wherein said composition is a solution containing the compound of formula 1 in a concentration from 1 mg/mL to 50mg/mL.

### Claim 19 (depends on 14)

The pharmaceutical composition of claim 14 wherein said composition is a solution containing the compound of formula 1 in a concentration from 1 mg/mL to 10mg/mL.

### Claim 20 (depends on 14)

The pharmaceutical composition of claim 14 wherein said composition is a solution containing the compound of formula 1 in a concentration from 0.1 mg/mL to 10mg/mL.