CD8+ T-Cell Density Biomarker for Early Immunotherapy Response

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Solution Overview

Problem

There is a lack of effective pharmacodynamic biomarkers for immunotherapy drugs that can provide early information on clinical outcomes, posing challenges in clinical trials and patient treatment decisions.

Innovation Solution

Utilizing CD8+ T-cell density as a biomarker, measured by fold change (FC) and on-treatment density (OTD), with defined threshold values to predict the efficacy of immunotherapy treatments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional endpoints (overall response rates, progression free survival, overall survival) are used to assess immunotherapy efficacy, then comprehensive clinical outcomes are measured, but the assessment time is extended to the end of the study period, delaying early prediction capability

Engineering Contradiction:

Improveclinical outcome prediction accuracyVSAvoidtime to obtain clinical outcome information

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent applies preliminary action by measuring CD8+ T cell density at an early time point during immunotherapy treatment (before conventional endpoints are reached) to predict eventual clinical outcomes. This early biomarker assessment allows clinicians to forecast treatment efficacy without waiting for the extended study period required for traditional endpoints like overall survival, thus resolving the contradiction between prediction accuracy and time delay.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If immunotherapy treatment continues without early efficacy prediction, then all patients receive extended treatment exposure, but resources are wasted on non-responders and patients suffer from prolonged ineffective therapy

Engineering Contradiction:

Improvetreatment efficacyVSAvoidresource consumption and patient exposure to ineffective therapy

Core Design Contradiction:

ReliabilityVSLoss of energy

Solution Approach 1:

The patent implements feedback by using early CD8+ T cell density measurements to inform subsequent treatment decisions. The biomarker data provides feedback on treatment efficacy, enabling clinicians to identify non-responders early and discontinue ineffective immunotherapy, thereby reducing resource waste and patient exposure to useless treatment while maintaining reliable care for responders.

Inventive Principle:

Principle #23Feedback

3Loss of time

If early biomarker assessment is implemented, then early prediction of treatment response is achieved, but the complexity of biomarker measurement and analysis is introduced

Engineering Contradiction:

Improvetime to predictionVSAvoidbiomarker measurement and analysis system

Core Design Contradiction:

Loss of timeVSDevice complexity

Solution Approach 1:

The patent applies the taking out principle by extracting and focusing on a single, specific biomarker (CD8+ T cell density) rather than employing complex panels of multiple biomarkers. This targeted approach to measuring one key immunological parameter simplifies the measurement and analysis system while still achieving early prediction capability, thus resolving the contradiction between early prediction and system complexity.

Inventive Principle:

Principle #2Taking out (Extraction)

Data Source

PatentUS20250377358A1Novel biomarker to predict efficacy of cancer immunotherapy

Publication Date: 2025.12.11 F HOFFMANN LA ROCHE INC

AI summary

The present invention provides a novel biomarker comprising a composite score of T cell density in paired biopsies taken before and after treatment of a patient, with cancer, to inform potential outcomes in immunotherapy, including but not limited to clinical trials. The invention also provides methods to determine whether a cancer patient is likely to benefit from immunotherapy by using said biomarker.