# US 2021/0239703 A1 · Pd1 and pdl-1 expression during progression from myelodysplastic syndrome to acute myelogenous leukemia

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- Number: US 2021/0239703 A1
- Document ID: US20210239703A1
- Status: Published application
- Kind: A1
- Application number: 16/081,229
- Filed: 2017-03-16
- Published: 2021-08-05
- Earliest claimed: 2017-03-16
- Assignees: H. Lee Moffitt Cancer Center and Research Institute, Inc.
- Applicants: H. Lee Moffitt Cancer Center and Research Institute, Inc.
- Inventors: Alan List; Sheng Wei
- Web page: https://patentgrep.com/patent/US20210239703A1

## CPC

- G01N 33/57505: of the blood, e.g. leukaemia
- C07K 16/2818: {against CD28 or CD152}
- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 39/001129: {Molecules with a "CD" designation not provided for elsewhere}
- G01N 2333/70521: CD28, CD152
- G01N 2333/70596: Molecules with a "CD"-designation not provided for elsewhere in G01N2333/705
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G01N 2800/7028: Cancer
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- 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)
- 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)

## Abstract

The present disclosure relates to a method for diagnosing in a subject the progression from myelodysplastic syndrome (MDS) to acute myelogenous leukemia (AML). Also disclosed are methods of treating AML in a subject diagnosed by the disclosed methods.

## Claims

### Claim 1

A method for treating acute myelogenous leukemia (AML) in a subject, comprising:
assaying a sample from the subject for the expression of PD-1 on CD71+ and CD34+ progenitor cells, the expression of PD-L1 on CD33+ myeloid derived stem cells (MDSCs), or a combination thereof,
detecting an increase in PD-1 expression on progenitor cells or decrease in PD-L1 expression on MDSCs as an indication of progression from myelodysplastic syndrome (MDS) to AML, and
treating the subject for AML.

### Claim 2 (depends on 1)

The method of claim 1, comprising assaying a sample from the subject for the expression of PD-1 on CD71+ and CD34+ progenitor cells, wherein an increase in PD-1 expression on progenitor cells is an indication of progression from MDS to AML.

### Claim 3 (depends on 1)

The method of claim 1, comprising assaying a sample from the subject for the expression of PD-L1 on CD33+ myeloid derived stem cells (MDSCs), wherein a decrease in PD-L1 expression on MDSCs is an indication of progression from MDS to AML.

### Claim 4 (depends on 1)

The method of claim 1, comprising assaying a sample from the subject for the expression of PD-1 on CD71+ and CD34+ progenitor cells and the expression of PD-L1 on CD33+ myeloid derived stem cells (MDSCs), wherein an increase in PD-1 expression on progenitor cells and a decrease in PD-L1 expression on MDSCs is an indication of progression from MDS to AML.

### Claim 5 (depends on 1)

The method of claim 1, wherein the increase in PD-1 expression on progenitor cells is at least 5 fold relative to a healthy control.

### Claim 6 (depends on 1)

The method of claim 1, wherein the decrease in PD-L1 expression on MDSCs is at least 450 fold relative to a healthy control.

### Claim 7

(canceled)

### Claim 8 (depends on 1)

The method of claim 1, wherein the treating the subject for AML comprises administration of a chemotherapeutic agent.

### Claim 9 (depends on 8)

The method of claim 8, wherein the chemotherapeutic agent is selected from cytarabine, daunorubicin, idarubicin, mitoxantrone, vincristine, Cladribine (Leustatin®, 2-CdA), Fludarabine (Fludara®), Topotecan, Etoposide (VP-16), 6-thioguanine (6-TG), Hydroxyurea (Hydrea®), Corticosteroid drugs, such as prednisone or dexamethasone (Decadron®), Methotrexate (MTX), 6-mercaptopurine (6-MP), Azacitidine (Vidaza®), or Decitabine (Dacogen®).

### Claim 10 (depends on 1)

The method of claim 1, wherein the treating the subject for AML comprises administration of an immunotherapeutic agent.

### Claim 11 (depends on 10)

The method of claim 10, wherein the immunotherapeutic agent is selected from an anti-PD1 antibody, an anti-PDL1 antibody, an anti-CTLA4 antibody, or a combination thereof.

### Claim 12 (depends on 1)

The method of claim 1, wherein the sample is a blood sample.

### Claim at position 13

13-24. (canceled)