Genetic Mutation Screening for ICB Therapy Patient Selection

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Solution Overview

Problem

Current immune checkpoint blockade (ICB) treatments for cancer are not effective for the majority of eligible patients due to high costs and severe side effects, highlighting the need for more precise patient selection methods.

Innovation Solution

Identifying mutations in specific genes associated with responsiveness to ICB therapy in a biological sample from a cancer patient, and administering ICB therapy only to those patients who show these mutations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ICB therapy is administered to all eligible patients, then more patients may benefit from treatment, but treatment costs and side effects increase significantly

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidside effects and costs
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent performs genetic testing to identify mutations in checkpoint genes (PD-1, PD-L1, CTLA-4) before administering ICB therapy. This preliminary genetic analysis allows clinicians to predict which patients are likely to respond to treatment, enabling them to administer ICB therapy only to those with responsive genetic profiles, thereby avoiding unnecessary side effects and costs for non-responders

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent applies different treatment strategies based on the specific genetic profile of each patient's tumor. By analyzing the presence or absence of specific mutations in checkpoint genes, the treatment approach is customized for each patient's molecular characteristics, rather than applying a uniform treatment protocol to all patients

Inventive Principle:
Principle #3Local quality

2Adaptability or versatility

If ICB therapy is administered to all eligible patients, then treatment coverage is maximized, but resource utilization becomes inefficient

Engineering Contradiction:
Improvetreatment coverageVSAvoidresource utilization efficiency
Core Design Contradiction:
Adaptability or versatilityVSProductivity

Solution Approach 1:

The patent implements preliminary genetic screening using next-generation sequencing or other molecular testing methods to identify patients with specific checkpoint gene mutations before initiating ICB therapy. This pre-screening process ensures that expensive ICB treatments are reserved for patients with high probability of response, optimizing healthcare resource allocation while maintaining broad adaptability through available testing methods

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the selection parameter for ICB therapy from broad clinical eligibility criteria to specific molecular markers (genetic mutations in checkpoint genes). This parameter transformation enables more precise patient stratification, improving resource efficiency by treating only those with molecularly-defined responsiveness while maintaining treatment adaptability through various genetic testing platforms

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If genetic testing is performed to identify responsive patients, then treatment precision improves, but diagnostic complexity and cost increase

Engineering Contradiction:
Improvepatient selection accuracyVSAvoiddiagnostic process complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent performs genetic testing as a preliminary step before ICB therapy administration. By using established molecular biology techniques such as next-generation sequencing, PCR, or FISH to detect checkpoint gene mutations, the method achieves high patient selection accuracy while relying on成熟的 diagnostic technologies that are becoming increasingly accessible in clinical settings

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses genetic markers (mutations in PD-1, PD-L1, CTLA-4 genes) as intermediary indicators to predict treatment responsiveness. These molecular intermediaries provide a measurable proxy for treatment efficacy, translating complex biological responses into detectable genetic signatures that can be analyzed using standardized laboratory methods

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS12275986B2Biomarkers associated with checkpoint immune therapy and methods of using same
Publication Date: 2025.04.15 DUKE UNIV
  • US12275986B2 patent drawing
  • US12275986B2 patent drawing
  • US12275986B2 patent drawing

AI summary

Provided herein are methods for treating cancer in a subject comprising administering an ICB therapy to a subject having cancer, wherein the subject's cancer comprises one or more mutations in two or more genes associated with responsiveness to immune checkpoint blockade (ICB).