Spatial Transcriptomic Biomarkers for Immunotherapy Responsiveness

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Solution Overview

Problem

Current biomarkers for predicting immunotherapy responsiveness in cancer patients lack precision due to their reliance on average gene expression across all cells in a tissue, failing to consider the specific cellular composition of the tumor microenvironment, leading to inaccurate treatment decisions and potential adverse effects.

Innovation Solution

Development of biomarkers using spatial transcriptomic analysis to measure the mRNA or protein expression levels of specific genes (NKG7, ULBP3, FPR2, MYC, CXCL10, NECTIN2, CD8A, HLA-DQA1, BMP2, INF-β, TNF-β, IL6, OX40-L, OX40, Tim3, HLA-C, and HLA-G) in distinct regions of the tumor microenvironment, such as tumor, immune, and stromal regions, to predict immunotherapy responsiveness and survival prognosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional mRNA expression analysis from pathological cancer tissue slides is used to select biomarkers, then the measurement process is simple and widely applicable, but the biomarkers lack precision in predicting immunotherapy responsiveness because they only reflect average gene expression across all cells without considering tumor microenvironment composition

Engineering Contradiction:
Improveprecision of immunotherapy responsiveness predictionVSAvoidcomplexity of spatial transcriptomic analysis system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The tissue section is segmented into distinct regions (tumor region, immune region, stromal region) based on morphological markers, allowing separate analysis of gene expression in each microenvironment compartment. This segmentation enables precise measurement of biomarker expression in specific cellular contexts rather than averaging across all cells.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The analysis transitions from uniform whole-tissue analysis to region-specific gene expression measurement. Each microenvironment region (tumor, immune, stromal) is analyzed with its own expression profile, capturing local biological characteristics that determine immunotherapy responsiveness. This local quality approach reveals spatial heterogeneity in biomarker expression.

Inventive Principle:
Principle #3Local quality

2Measurement precision

If spatial transcriptomic analysis based on GeoMx Digital Spatial Profiling system is used to measure gene expression in distinct tumor microenvironment regions, then the prediction precision of immunotherapy responsiveness is improved, but the measurement complexity and technical requirements increase

Engineering Contradiction:
Improveprecision of immunotherapy responsiveness predictionVSAvoiddifficulty of spatial transcriptomic measurement
Core Design Contradiction:
Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

Morphological markers are used to pre-identify and delineate regions of interest (tumor, immune, stromal regions) before performing gene expression analysis. This preliminary spatial mapping simplifies the subsequent transcriptomic measurement by restricting analysis to predefined anatomical compartments, reducing the complexity of spatial coordinate management.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Morphological markers serve as intermediaries that bridge tissue morphology and gene expression data. These markers first label and define spatial regions, which then guide the extraction and analysis of region-specific transcriptomic profiles, facilitating the integration of spatial and molecular information.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP4624593A1Biomarker for predicting immunotherapeutic responsiveness based on spatial transcriptome analysis and uses thereof
Publication Date: 2025.10.01 SUNG KWANG MEDICAL FOUND
  • EP4624593A1 patent drawingFigure 1
  • EP4624593A1 patent drawingFigure 2A~2B
  • EP4624593A1 patent drawingFigure 3A~3D

AI summary

The present invention relates to a biomarker for predicting immunotherapeutic responsiveness based on spatial transcriptome analysis and uses thereof and, in particular, to: a marker composition for predicting the responsiveness of cancer patients to immunotherapy; a composition for predicting the responsiveness of cancer patients to immunotherapy; a kit for predicting the responsiveness of cancer patients to immunotherapy, comprising the composition; a method for providing information for predicting the responsiveness of cancer patients to immunotherapy; and a method for providing information for predicting the survival prognosis of cancer patients. The biomarker for predicting immunotherapeutic responsiveness, according to the present invention, was discovered by applying spatial transcriptome technology and analyzing cell group-specific gene expression values according to location information of cells in tissue sections, and can more precisely and accurately predict the responsiveness of cancer patients to immunotherapy and the survival prognosis of patients, thus enabling suitable treatments for patient groups, which may result in improved therapeutic effects and a reduction in pain and costs for patients.