Method for determining the response of a malignant disease to an immunotherapy

A technology for immunotherapy and disease, applied in biochemical equipment and methods, pharmaceutical formulations, antibody medical components, etc., can solve different problems

Pending Publication Date: 2020-09-04
迪莫迪特里希
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the problem is that even patients with the same clinical presentation may respond differently to the same treatment or to the same active substance

Method used

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  • Method for determining the response of a malignant disease to an immunotherapy
  • Method for determining the response of a malignant disease to an immunotherapy
  • Method for determining the response of a malignant disease to an immunotherapy

Examples

Experimental program
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Effect test

Embodiment 1

[0095] Example 1: CTLA4-based DNA methylation predicts malignant disease to inhibit PD-1 immune checkpoint signaling pathway Clinical Studies of Responses to

[0096] The patient cohort examined included a total of 50 patients diagnosed with metastatic malignant melanoma. Before immunotherapy, tumor tissue samples were removed from patients, fixed with formalin, and embedded in paraffin. Patients were treated with anti-PD-1 immune checkpoint blockade with pembrolizumab or nivolumab between October 2014 and April 2017.

[0097] For DNA methylation analysis, thin sections of tumor tissue samples with a thickness of 10 μm were first made, and then mounted on glass carriers. Based on HE sections, tumor areas were identified by pathological evaluation and scraped from glass carriers for further processing. Bisulfite-converted DNA was delivered from the tumor area using the InnuCONVERT Bisulfite All-in-One Kit (Analytik Jena, Jena, Germany) according to the manufacturer's inst...

Embodiment 2

[0105] Example 2: Determination of co-methylation of CTLA4, CD86, CD28, CD80 and ICOS in various malignant diseases

[0106] In the context of the present invention, it is also recognized that a patient's response to immunotherapy can be determined not only by DNA methylation analysis of CTLA4, but also by the immunomodulatory genes whose DNA methylation correlates with the DNA methylation of CTLA4 DNA methylation analysis to determine. The immunoregulatory genes CD28, CD80, CD86 and / or ICOS are particularly suitable here. These genes are functionally related to CTLA4. In addition, CD28 and ICOSim in the genome are also located near CTLA4.

[0107] Co-methylation of CTLA4, CD28, CD80, CD86, and ICOS was examined using genome-wide DNA methylation analysis, such as the Infinium HumanMethylation45 bead chip (Illumina, Inc., San Diego, CA, USA). TCGA Research Network ( http: / / cancergenome.nih.gov / ) describes the generation of HumanMethylation450 BeadChip raw data. In conc...

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Abstract

The invention relates to a method for predicting the response of a malignant disease to an immunotherapy which inhibits the PD-1 immune checkpoint signal path. The method is characterized in that at least one part of an immuno-regulatory gene selected from CTLA4, CD86, CD28, CD80 and / or ICOS of cells of the malignant disease and / or immune cells which interact with the cells of the malignant disease is subjected to a DNA methylation analysis, and the response of the malignant disease to the immunotherapy is predicted using the result.

Description

[0001] Citations from earlier applications [0002] This application claims priority from German patent application DE 102017125780.2, the disclosure content of which is hereby incorporated by reference. [0003] sequence listing [0004] This application contains an electronic sequence listing in txt format with 78 sequences conforming to WIPO ST.25 standard as part of the specification. technical field [0005] The present invention relates to a predictive molecular diagnostic method and predictive biomarkers and their use in oncology medicine to predict the response of malignant diseases to immunotherapy. Furthermore, the invention also relates to kits for carrying out said methods. Background technique [0006] Personalized medicine is based on the development of therapies tailored to patients suffering from a certain disease. A very promising approach in oncology utilizes immunotherapies known as immune checkpoint inhibitors, as they are able to show outstanding r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886
CPCC12Q1/6886C12Q2600/106C12Q2600/154A61P35/00A61K39/3955
Inventor 迪莫·迪特里希
Owner 迪莫迪特里希
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