# US 12,611,444 B2 · IL-36 cytokine expressing oncolytic viruses for treating cancer

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- Number: US 12,611,444 B2
- Document ID: US12611444B2
- Status: Granted
- Kind: B2
- Application number: 17/696,978
- Filed: 2022-03-17
- Published: 2022-07-07
- Granted: 2026-04-28
- Earliest claimed: 2019-09-20
- Assignees: University of Pittsburgh—Of the Commonwealth System of Higher Education
- Applicants: University of Pittsburgh—of the Commonwealth System of Higher Education
- Inventors: Zong Sheng Guo; Binfeng Lu; David L. Bartlett
- Web page: https://patentgrep.com/patent/US12611444B2

## CPC

- A61K 38/20: Interleukins [IL]
- A61K 35/15: Cells of the myeloid line, e.g. granulocytes, basophils, eosinophils, neutrophils, leucocytes, monocytes, macrophages or mast cells; Myeloid precursor cells; Antigen-presenting cells, e.g. dendritic cells (presenting a specific antigen A61K39/00; therapeutic combinations of antibodies, or fragments thereof, and blood-derived cells A61K39/00)
- A61K 35/17: Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes (when activated by a specific antigen A61K39/00)
- A61K 35/742: Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
- A61K 35/768: Oncolytic viruses not provided for in groups A61K35/761 - A61K35/766
- A61K 39/0011: {Cancer antigens}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 35/00: Antineoplastic agents
- C07K 14/54: Interleukins [IL]
- C12N 15/86: Viral vectors
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C12N 2710/24132: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- C12N 2710/24143: viral genome or elements thereof as genetic vector
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present disclosure provides interleukin-36 (IL-36) cytokine (e.g., IL-36γ) expressing oncolytic viruses, and compositions comprising thereof. The present disclosure further provides methods of using said oncolytic viruses and compositions for treating cancer, and for improving a subject's responsiveness to an immunomodulatory agent.

## Claims

### Claim 1

An oncolytic vaccinia virus comprising a recombinant nucleic acid molecule encoding interleukin-36γ (IL-36γ), wherein the oncolytic vaccinia virus lacks the expression of a functional thymidine kinase (TK), wherein the recombinant nucleic acid molecule is operably linked to a promoter.

### Claim 2 (depends on 1)

The oncolytic virus of claim 1, wherein the recombinant nucleic acid molecule is integrated into the genome of the oncolytic virus.

### Claim 3 (depends on 1)

The oncolytic virus of claim 1, wherein the oncolytic vaccinia virus:
a) comprises a mutation of a J2R gene;
b) lacks the expression of a functional vaccinia growth factor (VGF);
c) comprises a mutation of a C11R gene;
d) lacks the expression of a functional serine proteinase inhibitor 1 (SPI-1);
e) comprises a mutation of a B22R gene;
f) comprises a mutation of a B13R gene; and/or
g) lacks the expression of a functional serine proteinase inhibitor 2 (SPI-2).

### Claim 4 (depends on 3)

The oncolytic virus of claim 3, wherein the recombinant nucleic acid molecule is integrated into the locus of the J2R gene.

### Claim 5 (depends on 3)

The oncolytic virus of claim 3, wherein the oncolytic vaccinia virus lacks the expression of the functional TK and the expression of the functional VGF.

### Claim 6 (depends on 3)

The oncolytic virus of claim 3, wherein the oncolytic vaccinia virus comprises the mutation of the J2R gene and the mutation of the C11R gene.

### Claim 7 (depends on 3)

The oncolytic virus of claim 3, wherein the oncolytic vaccinia virus lacks the expression of the functional TK, of the functional SPI-2, and of the functional SPI-1.

### Claim 8 (depends on 3)

The oncolytic virus of claim 3, wherein the oncolytic vaccinia virus comprises the mutation of the J2R gene, the mutation of the B22R gene, and the mutation of the B13R gene.

### Claim 9 (depends on 1)

The oncolytic virus of claim 1, wherein the oncolytic vaccinia virus is a Western Reserve strain.

### Claim 10 (depends on 1)

A pharmaceutical composition comprising the oncolytic virus of claim 1.

### Claim 11 (depends on 10)

The pharmaceutical composition of claim 10, further comprising an immunomodulatory agent.