# US 11,992,516 B2 · Compositions comprising IL-15-based molecules and immune checkpoint inhibitor antibodies

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- Number: US 11,992,516 B2
- Document ID: US11992516B2
- Status: Granted
- Kind: B2
- Application number: 18/045,572
- Filed: 2022-10-11
- Published: 2023-06-22
- Granted: 2024-05-28
- Earliest claimed: 2014-06-30
- Assignees: Altor BioScience Corporation
- Applicants: Altor Bioscience, LLC
- Inventors: Bai Liu; Peter Rhode; Wenxin Xu; Hing C. Wong
- Web page: https://patentgrep.com/patent/US11992516B2

## CPC

- A61K 38/2086: {IL-13 to IL-16}
- A61K 38/1793: {for cytokines; for lymphokines; for interferons}
- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61K 47/6425: {the peptide or protein in the drug conjugate being a receptor, e.g. CD4, a cell surface antigen, i.e. not a peptide ligand targeting the antigen, or a cell surface determinant, i.e. a part of the surface of a cell}
- A61P 31/18: for HIV
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/32: against translation products of oncogenes
- A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis
- C07K 14/35: from Mycobacteriaceae (F)
- C07K 14/5443: {IL-15}
- C07K 14/7155: {for interleukins [IL]}
- C07K 16/2818: {against CD28 or CD152}
- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- C07K 16/2887: {against CD20}
- C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere}
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C07K 2319/32: fusions with soluble part of a cell surface receptor, "decoy receptors"
- 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

The invention features combination therapies using an IL-15-based superagonist complex and an antibody to effectively treat subjects with cancer and infectious diseases.

## Claims

### Claim 1

A composition comprising: synergistically effective amounts of an immune checkpoint inhibitor antibody and an IL-15N72D:IL-15RαSu/Fc complex (ALT-803), wherein the immune checkpoint inhibitor antibody is a CTLA-4, PD-1, or PD-L1 antibody, wherein said ALT-803 comprises a dimeric IL-15RaSu/Fc and two IL-15N72D molecules, wherein the composition is formulated for administration to a human subject suffering from a neoplasia comprising the immune checkpoint molecule targeted by the antibody, and wherein the amounts are synergistically effective for treatment of said neoplasia.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the IL-15N72D molecule comprises the amino acid sequence of SEQ ID NO: 3.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the IL-15RαSu/Fc comprises the amino acid sequence of SEQ ID NO: 6.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the neoplasia is selected from the group consisting of a glioblastoma, prostate cancer, hematological cancer, B-cell neoplasms, multiple myeloma, B-cell lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, acute myeloid leukemia, cutaneous T-cell lymphoma, T-cell lymphoma, a solid tumor, urothelial/bladder carcinoma, melanoma, lung cancer, renal cell carcinoma, breast cancer, gastric and esophageal cancer, head and neck cancer, colorectal cancer, ovarian cancer, non-small cell lung carcinoma, B cell non-Hodgkin lymphoma, and squamous cell head and neck carcinoma.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the synergistically effective amount of said ALT-803 is between 0.1 μg/kg and 100 mg/kg.

### Claim 6 (depends on 5)

The composition of claim 5, wherein the synergistically effective amount of said ALT-803 is between 0.1 μg/kg and 1 mg/kg.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the ALT-803 is formulated for systemic administration, intravenous administration, subcutaneous administration, intramuscular administration, intravesical administration or by instillation administration to the subject.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the ALT-803 is formulated for subcutaneous administration to the subject.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the antibody is formulated for intravenous administration to the subject.

### Claim 10 (depends on 1)

The composition of claim 1, wherein the antibody is selected from the group consisting of ipilimumab, nivolumab, pembrolizumab, and durvalumab.