# US 12,109,346 B2 · Galectin-3 plasmapheresis therapy

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- Number: US 12,109,346 B2
- Document ID: US12109346B2
- Status: Granted
- Kind: B2
- Application number: 16/988,679
- Filed: 2020-08-09
- Published: 2021-01-07
- Granted: 2024-10-08
- Earliest claimed: 2015-03-27
- Assignees: Eliaz Therapeutics, Inc.
- Applicants: Eliaz Therapeutics, Inc
- Inventors: Isaac Eliaz
- Web page: https://patentgrep.com/patent/US12109346B2

## CPC

- A61M 1/362: {changing physical properties of target cells by binding them to added particles to facilitate their subsequent separation from other cells, e.g. immunoaffinity}
- A61K 35/14: Blood; Artificial blood (perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42)
- A61K 35/16: Blood plasma; Blood serum (umbilical cord blood A61K35/51)
- 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 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 40/11: T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
- A61K 40/31: Chimeric antigen receptors [CAR]
- A61K 40/42: Cancer antigens
- A61M 1/3486: {Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents}
- A61M 1/3496: {Plasmapheresis; Leucopheresis; Lymphopheresis (A61M1/3472 takes precedence)}
- A61M 1/3683: {using photoactive agents}
- A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent}
- C07K 16/2851: {against the lectin superfamily, e.g. CD23, CD72}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- 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

A system and method for the practice of apheresis employs modules in the system which can be selected for a particular patient to treat particular situations or combinations of difficulties. In one example, Gal-3 mediates a large number of body reactions, and is an effective protector of tumor microenvironments and the like, as well inflammation driver. Removal of Gal-3 may make antic-cancer treatments, like photopheresis and TNF administration more effective. Separate modules, such as one for photopheresis and one for TNF receptor removal, may be combined with a module for the reduction of Gal-3, to render the combination of treatments each more effective than if administered alone.

## Claims

### Claim 1

A method for treating a mammal suffering from a tumorous cancer in an ex vivo system, comprising:
withdrawing an amount of blood from said mammal and introducing it, or plasma separated therefrom, into an ex vivo treatment system and subsequently returning said withdrawn blood to said mammal, following treatment, to said mammal, wherein said method comprises:
selectively withdrawing at least ten percent of galectin-3 in said withdrawn blood or plasma separated therefrom by passing said blood or plasma through a module provided with a moiety which selectively binds galectin-3, wherein said moiety is selected from the group consisting of an antibody, antibody fragment, non-antibody peptides, each of which selectively binds galectin-3, a polysaccharide which selectively binds galectin-3, or a combination thereof;
wherein said method further comprises administering to said mammal at least one of a PD-1 inhibitor and a PD-L1 in conjunction with said withdrawal of blood.

### Claim 2 (depends on 1)

The method of claim 1, wherein said method further comprises administering a dose of CAR-T cells to said patient in conjunction with said withdrawal of blood.

### Claim 3 (depends on 1)

The method of claim 1, wherein said method comprises treating said mammal with photodynamic therapy comprising exposure of said mammal to light selected so as to activate a photosensitizer administered to said mammal.

### Claim 4 (depends on 1)

The method of claim 1, wherein said method further comprises selectively withdrawing at least one of TNFα and TNFβ receptors from blood of said mammal by passing said withdrawn blood through a module with a moiety which selectively binds at least one of receptors for TNFα or receptors for TNFβ.

### Claim 5

A method for treating a mammal suffering from a tumorous cancer in an ex vivo system, wherein said method comprises withdrawing an amount of blood from said mammal and introducing it or plasma separated therefrom into an ex vivo treatment system and subsequently returning said withdrawn blood to said mammal, following treatment, to said mammal, wherein said method comprises:
selectively withdrawing at least ten percent of galectin-3 in said withdrawn blood by passing said blood through a module provided with a moiety which selectively binds galectin-3, wherein said moiety is selected from the group consisting of an antibody, antibody fragment, non-antibody peptides, each of which selectively binds galectin-3, a polysaccharide which selectively binds galectin-3, or a combination thereof; and
selectively withdrawing at least one of TNFα or TNFβ receptors from said withdrawn blood passing said withdrawn blood through a module provided with a moiety which selectively binds at least one of TNFα or TNFβ receptors; said method further comprising administering to said patient an effective amount of CART-cells, a dose of PD-1 or PD-L1 inhibitor, or a photosensitizer for photodynamic therapy for said mammal.

### Claim 6

A method for treating a mammal in an ex vivo system, wherein said method comprises withdrawing an amount of blood from said mammal and introducing it into an ex vivo treatment system and subsequently returning said withdrawn blood to said mammal, following treatment, to said mammal, wherein said method comprises:
selectively withdrawing at least ten percent of galectin-3 in said withdrawn blood by passing said blood or plasma separated therefrom through a module provided with a moiety which selectively binds galectin-3, wherein said moiety is selected from the group consisting of an antibody, antibody fragment, non-antibody peptides, each of which selectively binds galectin-3, a polysaccharide which selectively binds galectin-3, or a combination thereof; and
selectively withdrawing at least one inflammatory cytokine from said withdrawn blood by passing said withdrawn blood through a module provided with a moiety which selectively binds said at least one inflammatory cytokine, prior to return of said withdrawn blood to said patient.

### Claim 7 (depends on 6)

The method of claim 6, wherein said at least one inflammatory cytokine is selected from the group consisting of CXCL-8, CCL2, CCL3, CCL4, CCL5, CCL11, CXCL10, a CCL cytokine, a CXL cytokine, CX3CL, and an XCL cytokine.

### Claim 8

A method of improving the immune response of a mammal in need thereof, comprising:
withdrawing an amount of blood from said mammal and introducing it into an ex vivo treatment system and subsequently returning said withdrawn blood to said mammal, following treatment, to said mammal, wherein said method comprises:
selectively withdrawing, through apheresis, an effective amount of at least one of TNFα receptors or TNFβ receptors present in said withdrawn blood by passing said blood or plasma separated therefrom through a module provided with a moiety which selectively binds said TNFα or TNFβ; and
administering to said mammal, in conjunction with said apheresis, an effective amount of at least one of PD-1 or PD-L1 inhibitor.