# US 10,261,091 B2 · Humoral immune response against tumor antigens after treatment with a cancer antigen specific active immunotherapy and its association with improved clinical outcome

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- Number: US 10,261,091 B2
- Document ID: US10261091B2
- Status: Granted
- Kind: B2
- Application number: 14/479,084
- Filed: 2014-09-05
- Published: 2015-03-05
- Granted: 2019-04-16
- Earliest claimed: 2013-09-05
- Assignees: Dendreon Corporation
- Applicants: Dendreon Corporation
- Inventors: Debraj GuhaThakurta; James Trager; Nadeem Sheikh
- Web page: https://patentgrep.com/patent/US10261091B2

## CPC

- G01N 33/6854: {Immunoglobulins}
- A61K 40/10: characterised by the cell type used
- A61K 40/4274: {Prostate associated antigens e.g. Prostate stem cell antigen [PSCA]; Prostate carcinoma tumor antigen [PCTA]; Prostatic acid phosphatase [PAP]; Prostate-specific G-protein-coupled receptor [PSGR]}
- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- G01N 33/57555: of the prostate
- A61K 2039/575: {humoral response}
- G01N 2500/00: Screening for compounds of potential therapeutic value
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G16H 50/50: for simulation or modelling of medical disorders
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- 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)
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Compositions and methods are provided herein for predicting therapeutic outcome by measuring patient response to cellular antigen specific active immunotherapy (CASAI) using predetermined biomarkers.

## Claims

### Claim 1

A method of treating a prostate cancer patient who is responsive to cancer antigen specific active immunotherapy (CASAI) using prostatic acid phosphatase as a target cancer antigen where the method comprises the steps of:
i. selecting a prostate cancer patient with white blood cells who has been treated with a cancer antigen specific active immunotherapy (CASAI) using prostatic acid phosphatase fused to granulocyte macrophage colony-stimulating factor as a target cancer antigen to activate the patient's white blood cells under ex vivo conditions and who has an increase in reactive antibody levels in two or more non-target predetermined biomarker antigens of prostate cancer where the increase in reactive antibody levels is determined using an immunoassay that detects reactive antibody levels for at least four of the following predetermined biomarker antigens of prostate cancer: PSA, KLK2, KRAS, ERAS, LGALS8, and LGALS3 compared to a baseline antibody level from before CASAI treatment; and,
ii. treating the prostate cancer patient with CASAI using a target cancer antigen comprising prostatic acid phosphatase fused to granulocyte macrophage colony-stimulating factor to activate the patient's white blood cells under ex vivo conditions.

### Claim 2 (depends on 1)

The method of claim 1, wherein the selected patient has elevated post-treatment antibody levels reactive to the target cancer antigen where the elevation is determined by obtaining a baseline and a post-treatment antibody level reactive to the target cancer antigen.

### Claim 3 (depends on 1)

The method of claim 1, wherein the baseline reactive antibody levels or the post-treatment reactive antibody levels from the patient are reactive IgG levels.

### Claim 4 (depends on 1)

The method of claim 1, wherein the reactive antibody levels are detected using a solid support surface and a fluorescent or enzymatic label.

### Claim 5 (depends on 1)

The method of claim 1, wherein the selected patient has an increase in reactive antibody levels of PSA and one or more other non-target predetermined biomarker antigens selected from the group consisting of KLK2, KRAS, ERAS, LGALS8, and LGALS3.

### Claim 6 (depends on 1)

The method of claim 1, wherein the selected patient has an increase in reactive antibody levels of ERAS and any one of four markers selected from the group consisting of KLK2, KRAS, LGALS8, LGALS3, and PSA.

### Claim 7 (depends on 1)

The method of claim 1, wherein the selected patient has an increase in reactive antibody levels of KRAS and any one of four markers selected from the group consisting of KLK2, ERAS, LGALS8, LGALS3, and PSA.

### Claim 8 (depends on 1)

The method of claim 1, wherein the selected patient has an increase in reactive antibody levels of ERAS.

### Claim 9 (depends on 1)

The method of claim 1, wherein the selected patient has an increase in reactive antibody levels of KLK2.

### Claim 10 (depends on 1)

The method of claim 1, wherein the selected patient has an increase in reactive antibody levels of PSA.

### Claim 11 (depends on 1)

The method of claim 1, wherein the CASAI is sipuleucel-T treatment.
