# US 2019/0170730 A1 · Ecm composition, tumor microenvironment platform and methods thereof

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- Number: US 2019/0170730 A1
- Document ID: US20190170730A1
- Status: Published application
- Kind: A1
- Application number: 16/172,606
- Filed: 2018-10-26
- Published: 2019-06-06
- Earliest claimed: 2011-10-04
- Assignees: Mitra Biotech Private Limited
- Applicants: Mitra Biotech Private Limited
- Inventors: Mallikarjun SUNDARAM; Pradip MAJUMDER; Biswanath MAJUMDER; Misti JAIN; Saravanan THIAGARAJAN; Dency PINTO; Padhma RADHAKRISHNAN
- Web page: https://patentgrep.com/patent/US20190170730A1

## CPC

- G01N 33/5011: {for testing antineoplastic activity}
- C12N 5/0693: {Tumour cells; Cancer cells}
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/5041: {involving analysis of members of signalling pathways}
- G01N 33/5088: {of vertebrates}
- G01N 33/575: for cancer
- C12N 2503/00: Use of cells in diagnostics
- C12N 2533/90: Substrates of biological origin, e.g. extracellular matrix, decellularised tissue
- 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
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

The present disclosure relates to an Extra Cellular Matrix composition specific for cancer type and a tumor microenvironment platform for long term culturing of tumor tissue, wherein said culturing provides human ligands and tumor tissue micro-environment to mimic physiologically relevant signalling systems. The present disclosure further relates to the development of a Clinical Response Predictor and its application in the prognostic field (selection of treatment option for the patient) and translational biology field (development of anticancer drugs). The disclosure further relates to a method of predicting clinical response of a tumor patient to drug(s). The disclosure further relates to a method for screening tumor cells for the presence of specific markers for determining the viability of said cells for indication of tumor status.

## Claims

### Claim at position 1

1-27. (cancelled)

### Claim 28

A method to assess the effect of an anticancer drug on a tumor tissue, the method comprising,
adding a culture medium, serum, plasma, and peripheral blood mononuclear cells to a platform coated with an extracellular matrix (ECM) composition to obtain a tumor microenvironment platform;
adding a non-homogenized section of a tumor tissue to the tumor microenvironment platform, wherein the tumor tissue is obtained from a patient;
adding an anticancer drug to the tumor microenvironment platform; and
culturing the non-homogenized section of the tumor tissue on the tumor microenvironment platform in the presence of the anti-cancer drug, wherein the serum, the plasma and the peripheral blood mononuclear cells are autologous to said patient.

### Claim 29 (depends on 28)

The method of claim 28, further comprising culturing the non-homogenized section of the tumor tissue on the tumor microenvironment platform in the presence of the anti-cancer drug for at least 48 hours.

### Claim 30 (depends on 29)

The method of claim 29, further comprising conducting a plurality of assays on the tumor tissue or a supernatant from the culture medium, wherein the plurality of assays is selected from the group consisting of a cell viability assay, a cell death assay, a cell proliferation assay, a tumor morphology assay, a tumor stroma content assay, a cell metabolism assay, a senescence assay and any combinations thereof.

### Claim 31 (depends on 28)

The method of claim 28, wherein the ECM composition comprises at least three components selected from the group consisting of collagen 1, collagen 3, collagen 4, collagen 6, Fibronectin, Vitronectin, Cadherin, Filamin A, Vimentin, Osteopontin, Laminin, Decorin, and Tenascin C.

### Claim 32 (depends on 31)

The method of claim 31, wherein the concentrations of the at least three components are selected from collagen 1 at a concentration ranging from about 0.01 μg/ml to about 100 μg/ml, collagen 3 at a concentration ranging from about 0.01 μg/ml to about 100 μg/ml, collagen 4 at a concentration ranging from about 0.01 μg/ml to about 500 μg/ml, collagen 6 at a concentration ranging from about 0.01 μg/ml to about 500 μg/ml, Fibronectin at a concentration ranging from about 0.01 μg/ml to about 750 μg/ml, Vitronectin at a concentration ranging from about 0.01 μg/ml to about 95 μg/ml, Cadherin at a concentration ranging from about 0.01 μg/ml to about 500 μg/ml, Filamin A at a concentration ranging from about 0.01 μg/ml to about 500 μg/ml, Vimentin at a concentration ranging from about 0.01 μg/ml to about 100 μg/ml, Osteopontin at a concentration ranging from about 0.01 μg/ml to about 150 μg/ml, Laminin at a concentration ranging from about 0.01 μg/ml to about 100 μg/ml, Decorin at a concentration ranging from about 0.01 μg/ml to about 100 μg/ml and Tenascin C at a concentration ranging from about 0.01 μg/ml to about 500 μg/ml.

### Claim 33 (depends on 28)

The method of claim 28, wherein the tumor tissue is a primary tumor tissue, or a xenograft derived from a primary tumor tissue.