# US 11,998,580 B2 · Group B adenovirus-containing formulation

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- Number: US 11,998,580 B2
- Document ID: US11998580B2
- Status: Granted
- Kind: B2
- Application number: 16/965,549
- Filed: 2019-01-31
- Published: 2021-04-29
- Granted: 2024-06-04
- Earliest claimed: 2018-01-31
- Assignees: Akamis Bio Limited
- Applicants: Akamis Bio Limited
- Inventors: Simon Alvis; Magdalena Kieltyka
- Web page: https://patentgrep.com/patent/US11998580B2

## CPC

- A61K 35/761: Adenovirus
- 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 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- 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)

## Abstract

The present disclosure provides a liquid formulation suitable for a group B adenovirus, comprising: a) a group B adenovirus, such as replication competent group B adenovirus, b) 15 to 25% v/v glycerol, for example 16, 17, 18, 19, 20, 21% v/v glycerol; and c) 0.1 to 1.5% v/v ethanol, for example 0.2-1%, such as 1% v/v ethanol; and d) a buffer, and e) optionally an amino acid, wherein the pH of the formulation is in the range 8.0 to 9.6, and use of the same in treatment, particular in the treatment of cancer.

## Claims

### Claim 1

A liquid formulation suitable for a group B adenovirus, comprising:
a) a group B adenovirus,
b) 15 to 25% v/v glycerol;
c) 0.1 to 1.5% v/v ethanol;
d) 0.01-0.3 mM methionine; and
e) a buffer,
wherein:
the pH of the formulation is in the range 8.0 to 9.6, and
the formulation does not comprise a sugar.

### Claim 2 (depends on 1)

The formulation according to claim 1, wherein the formulation is for administration by intravenous injection.

### Claim 3 (depends on 2)

The formulation according to claim 2, wherein the formulation is for administration by slow injection.

### Claim 4 (depends on 2)

The formulation according to claim 2, wherein the formulation is for administration by infusion.

### Claim 5 (depends on 1)

The formulation according to claim 1, further comprising a surfactant.

### Claim 6 (depends on 5)

The formulation according to claim 5, further comprising polysorbate.

### Claim 7 (depends on 6)

The formulation according to claim 6, further comprising 0.05-0.15% polysorbate.

### Claim 8 (depends on 6)

The formulation according to claim 6, wherein the formulation comprises polysorbate 80.

### Claim 9 (depends on 1)

The formulation according to claim 1, further comprising arginine.

### Claim 10 (depends on 9)

The formulation according to claim 9, further comprising 5 to 20 mM arginine.

### Claim 11 (depends on 1)

The formulation according to claim 1, wherein the buffer is selected from meglumine, glycine, TRIS and combinations thereof.

### Claim 12 (depends on 11)

The formulation according to claim 11, wherein the formulation comprises meglumine buffer.

### Claim 13 (depends on 1)

The formulation according to claim 1, wherein the formulation does not comprise HEPES buffer.

### Claim 14 (depends on 1)

The formulation according to claim 1, wherein the formulation comprises:
a) 15-20% v/v glycerol;
b) 1-1.5% v/v ethanol;
c) 0.1-0.2% v/v polysorbate 80;
d) 0.2-0.3 mM methionine;
e) 10-20 mM arginine; and
f) a buffer;
wherein the pH of the formulation is at a pH in the range 8.0 to 9.6.

### Claim 15 (depends on 1)

A method of treating cancer in a patient in need thereof, comprising administering a therapeutically effective amount of the formulation according to claim 1 to the patient.

### Claim 16 (depends on 15)

The method of treating cancer in a patient according to claim 15, wherein the cancer is independently selected from colorectal cancer, hepatoma, prostate cancer, pancreatic cancer, breast cancer, ovarian cancer, thyroid cancer, renal cancer, bladder cancer, head and neck cancer, or lung cancer.

### Claim 17 (depends on 15)

The method of treating cancer in a patient according to claim 15, wherein the formulation is administered by intravenous or intratumoral injection.