# US 12,594,320 B2 · Method for treating checkpoint inhibitors induced adverse events

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- Number: US 12,594,320 B2
- Document ID: US12594320B2
- Status: Granted
- Kind: B2
- Application number: 17/427,698
- Filed: 2020-02-03
- Published: 2022-04-28
- Granted: 2026-04-07
- Earliest claimed: 2019-02-04
- Assignees: Assistance Publique-Hopitaux de Paris; Sorbonne Universite; Institut National De La Sante Et De La Recherche Medicale (Inserm); Vanderbilt University
- Applicants: Assistance Publique—HôPitaux De Paris; Sorbonne Université; Institut National De La Santé Et De La Recherche MéDicale (Inserm); Vanderbilt University
- Inventors: Joe-Elie Salem; Yves Allenbach; Mathieu Kerneis; Javid Moslehi; Douglas Johnson
- Web page: https://patentgrep.com/patent/US12594320B2

## CPC

- A61K 31/506: not condensed and containing further heterocyclic rings
- A61K 38/1774: {Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 37/02: Immunomodulators
- 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

## Abstract

The invention relates to the use of CTLA4 agonist for treating or preventing adverse events in patient treated with an immune checkpoint inhibitor.

## Claims

### Claim 1

A method for treating an adverse event induced by a treatment with an immune checkpoint inhibitor comprising administering an effective amount of abatacept to a patient in need thereof, wherein the adverse event is a de novo adverse event induced by the treatment with the immune checkpoint inhibitor, and not related to a preexisting immune condition in the patient treated with the immune checkpoint inhibitor.

### Claim 2 (depends on 1)

The method of claim 1, wherein the adverse event is an immune-mediated disease selected from the group consisting of myotoxicity, colitis, pneumonitis, hepatitis, hypophysitis, neurologic adverse effect, adrenal adverse effect, myositis, hematologic adverse effect, pancreatitis, endocrinological adverse effect, and nephritis.

### Claim 3 (depends on 1)

The method of claim 1, wherein the checkpoint inhibitor is selected from the group consisting of PD-1 inhibitors, PD-L1 inhibitors, anti-CTLA4, and combinations thereof.

### Claim 4 (depends on 3)

The method of claim 3, wherein the checkpoint inhibitor is a PD-1 inhibitor selected from the group consisting of nivolumab, pembrolizumab, pidilizumab, AMP-224, AMP-514, cemiplimab, toripalimab, spartalizumab, cetrelimab, and sasanlimab.

### Claim 5 (depends on 3)

The method of claim 3, wherein the checkpoint inhibitor is a PD-L1 inhibitor selected from the group consisting of atezolizumab, avelumab, and durvalumab.

### Claim 6 (depends on 3)

The method of claim 3, wherein the checkpoint inhibitor is an anti-CTLA4 selected from the group consisting of ipilimumab and tremelimumab.

### Claim 7 (depends on 1)

The method of claim 1, further comprising administering to the patient an immunosuppressant, wherein abatacept the CTLA4 and the immunosuppressant are administered simultaneously, separately, or sequentially.

### Claim 8 (depends on 7)

The method of claim 7, wherein the immunosuppressant is selected from the group consisting of mycophenolate mofetil, azathioprine, methotrexate, calcineurin inhibitors, cyclosporin, tacrolimus, MTOR inhibitors, sirolimus, temsirolimus, everolimus, anti-thymoglobulin, intravenous immunoglobulin, interleukin-6 inhibitors, tocilizumab, siltuximab, interleukin-1 pathway inhibitors, anakinra, rilonacept, canakinumab, TNF-α inhibitors, JAK inhibitors, TYK2 inhibitors, basiliximab, daclizumab, tocilizumab and alemtuzumab.

### Claim 9

A method for treating myocarditis induced by treatment with an immune checkpoint inhibitor, the method comprising administering an effective amount of abatacept to a patient in need thereof, wherein the adverse event is a de novo adverse event induced by the treatment with the immune checkpoint inhibitor, not related to a preexisting immune condition in the patient treated with the immune checkpoint inhibitor.

### Claim 10 (depends on 9)

The method of claim 9, wherein the checkpoint inhibitor is a PD-1 inhibitor selected from the group consisting of nivolumab, pembrolizumab, pidilizumab, AMP-224, AMP-514, cemiplimab, toripalimab, spartalizumab, cetrelimab, and sasanlimab.

### Claim 11 (depends on 9)

The method of claim 9, wherein the checkpoint inhibitor is a PD-L1 inhibitor selected from the group consisting of atezolizumab, avelumab, and durvalumab.

### Claim 12 (depends on 9)

The method of claim 9, further comprising administering to the patient an immunosuppressant, wherein the CTLA4 and the immunosuppressant are administered simultaneously, separately, or sequentially.

### Claim 13 (depends on 12)

The method of claim 12, wherein the immunosuppressant is selected from the group consisting of mycophenolate mofetil, azathioprine, methotrexate, calcineurin inhibitors, cyclosporin, tacrolimus, MTOR inhibitors, sirolimus, temsirolimus, everolimus, anti-thymoglobulin, intravenous immunoglobulin, interleukin-6 inhibitors, tocilizumab, siltuximab, interleukin-1 pathway inhibitors, anakinra, rilonacept, canakinumab, TNF-α inhibitors, JAK inhibitors, TYK2 inhibitors, basiliximab, daclizumab, tocilizumab and alemtuzumab.

### Claim 14

A method for preventing an adverse event induced by a treatment with an immune checkpoint inhibitor comprising administering an effective amount of abatacept to a patient in need thereof, wherein the adverse event is a de novo adverse event induced by the treatment with the immune checkpoint inhibitor, not related to a preexisting immune condition in the patient treated with the immune checkpoint inhibitor.

### Claim 15 (depends on 14)

The method of claim 14, wherein the adverse event is an immune-mediated disease selected from the group consisting of myotoxicity, colitis, pneumonitis, hepatitis, hypophysitis, neurologic adverse effect, adrenal adverse effect, myositis, hematologic adverse effect, pancreatitis, endocrinological adverse effect, and nephritis.

### Claim 16 (depends on 14)

The method of claim 14, wherein the adverse event is myocarditis.

### Claim 17 (depends on 14)

The method of claim 14, wherein the checkpoint inhibitor is selected from the group consisting of PD-1 inhibitors, PD-L1 inhibitors, anti-CTLA4, and combinations thereof.

### Claim 18 (depends on 17)

The method of claim 17, wherein the checkpoint inhibitor is a PD-1 inhibitor selected from the group consisting of nivolumab, pembrolizumab, pidilizumab, AMP-224, AMP-514, cemiplimab, toripalimab, spartalizumab, cetrelimab, and sasanlimab.

### Claim 19 (depends on 17)

The method of claim 17, wherein the checkpoint inhibitor is a PD-L1 inhibitor selected from the group consisting of atezolizumab, avelumab, and durvalumab.

### Claim 20 (depends on 17)

The method of claim 17, wherein the checkpoint inhibitor is an anti-CTLA4 selected from the group consisting of ipilimumab and tremelimumab.

### Claim 21 (depends on 14)

The method of claim 14, further comprising administering to the patient an immunosuppressant, wherein abatacept and the immunosuppressant are administered simultaneously, separately, or sequentially.