Immune Checkpoint Biomarkers for Accurate Responder Selection

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Solution Overview

Problem

Existing methods fail to accurately predict the efficacy of immune checkpoint inhibitors for patients with malignant tumors, necessitating a need to identify biomarkers that can determine which patients will benefit from these treatments.

Innovation Solution

The use of specific biomarker conditions defined by mathematical formulas involving CD8+ T cells, Foxp3+ T cells, and other immune cell subsets in tumor tissue or blood to predict the efficacy of immune checkpoint inhibitors, using immune checkpoint inhibitory substances as active ingredients.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional therapies or single-marker methods are used, then treatment is simpler to administer, but the ability to accurately predict treatment efficacy is insufficient

Engineering Contradiction:

Improveprediction accuracy of treatment efficacyVSAvoidcomplexity of biomarker evaluation system

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple immune cell markers (PD-1 on CD8+ T cells, Foxp3 on Treg cells, and CCR7 on CD8+ T cells) into a single integrated biomarker system. This merging of multiple measurement dimensions allows accurate prediction of immune checkpoint inhibitor efficacy while maintaining a unified evaluation framework that balances precision with operational feasibility.

Inventive Principle:

Principle #5Merging (Combining)

2Reliability

If multiple biomarker conditions are evaluated, then treatment efficacy prediction becomes more accurate, but the evaluation process becomes more complex

Engineering Contradiction:

Improvereliability of efficacy predictionVSAvoiddifficulty of biomarker measurement and analysis

Core Design Contradiction:

ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent transforms multiple biomarker measurements into standardized parameter ranges with defined thresholds. By establishing specific numerical criteria (e.g., PD-1 MFI ratio, CCR7 percentage ranges, Foxp3+ Treg cell proportions), the system converts complex biological measurements into comparable, quantifiable parameters that facilitate reliable prediction while simplifying the interpretation process.

Inventive Principle:

Principle #35Parameter changes

3Productivity

If immune checkpoint inhibitors are administered without proper patient selection, then more patients receive treatment, but treatment effectiveness decreases due to non-responders

Engineering Contradiction:

Improveoverall treatment coverageVSAvoidprecision of treatment response prediction

Core Design Contradiction:

ProductivityVSMeasurement precision

Solution Approach 1:

The patent implements preliminary biomarker evaluation before administering immune checkpoint inhibitors. By assessing PD-1 expression on CD8+ T cells, Foxp3 expression on Treg cells, and CCR7 expression on CD8+ T cells prior to treatment, the system identifies patients most likely to respond, ensuring that treatment is directed toward those who will benefit while maintaining appropriate treatment coverage.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS12571799B2Biomarkers for determining the efficacy of immune checkpoint inhibitors

Publication Date: 2026.03.10 ONO PHARMA CO LTD

AI summary

A method for identifying a patient with malignant tumor which can be expected to benefit more from an immune checkpoint inhibitor, and agent for suppressing the progression of, suppressing the recurrence of, and/or treating malignant tumor, being prescribed based thereon, comprising use of a combination of two sets of evaluation items and specific condition defined by each of combination thereof.