# US 11,304,998 B2 · Combination immunotherapies comprising IL-15 superagonists

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- Number: US 11,304,998 B2
- Document ID: US11304998B2
- Status: Granted
- Kind: B2
- Application number: 17/240,285
- Filed: 2021-04-26
- Published: 2021-08-26
- Granted: 2022-04-19
- Earliest claimed: 2017-05-26
- Assignees: Etubics Corporation
- Applicants: Etubics Corporation
- Inventors: Frank R. Jones; Adrian Rice; Elizabeth Gabitzsch; Yvette Latchman; Joseph Balint
- Web page: https://patentgrep.com/patent/US11304998B2

## CPC

- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 39/0011: {Cancer antigens}
- A61K 39/001182: {Carcinoembryonic antigen [CEA]}
- A61K 40/15: Natural-killer [NK] cells; Natural-killer T [NKT] cells
- A61K 40/36: Immune checkpoint inhibitors
- A61K 40/4266: {Carcinoembryonic antigen [CEA]}
- A61P 31/20: for DNA viruses
- A61P 35/00: Antineoplastic agents
- C12N 15/86: Viral vectors
- A61K 2039/5256: {expressing foreign proteins}
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/55527: {Interleukins}
- A61K 2239/31: characterized by the route of administration
- A61K 2239/38: characterised by the dose, timing or administration schedule
- C12N 2710/10334: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2710/10345: Special targeting system for viral vectors
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Methods and compositions for generating enhanced immune responses using adenovirus vectors that allow for multiple vaccinations in combination with an IL-15 superagonist complex in subjects in need thereof are provided.

## Claims

### Claim 1

A composition comprising a first recombinant adenovirus subtype 5 (Ad5) vector comprising a deletion in an E1 gene region, a deletion in an E2b gene region, and a nucleic acid sequence encoding a carcinoembryonic antigen (CEA) according to SEQ ID NO:3 or SEQ ID NO:4, and:
a) a second recombinant adenovirus vector comprising a nucleic acid sequence encoding an IL-15N72D domain of a human interleukin-15 (IL-15) superagonist complex and an IL-15RaSu/Fc fusion domain of the IL-15 superagonist complex; or
b) a third recombinant adenovirus vector comprising a nucleic acid sequence encoding an IL-15N72D domain of a human IL-15 superagonist complex and fourth recombinant adenovirus vector comprising a nucleic acid sequence encoding an IL-15RαSu/Fc fusion domain of the IL-15 superagonist complex.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the CEA is SEQ ID NO: 3.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the nucleic acid sequence encoding CEA is SEQ ID NO: 1 or SEQ ID NO: 100.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the CEA is SEQ ID NO:4.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the IL-15 superagonist complex is ALT-803.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the composition comprises at least 1×109 viral particles in a single dose.

### Claim 7 (depends on 6)

The composition of claim 6, wherein the composition comprises 1×109-5×1012 viral particles in a single dose.

### Claim 8 (depends on 7)

The composition of claim 7, wherein the composition comprises 1×1010-5×1012 viral particles in a single dose.

### Claim 9 (depends on 8)

The composition of claim 8, wherein the composition-comprises 1×1010-5×1011 viral particles in a single dose.