CD86 Testing for Predicting Immunotherapy Efficacy in Mucosal Lesions

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Solution Overview

Problem

Current therapeutic drugs for HPV infection and HPV-related tumors, which are immunotherapeutic agents, lack a clear correlation between their ability to induce anti-HPV-specific immunity and clinical therapeutic effect, particularly for cervical intraepithelial neoplasia (CIN), and there is no companion diagnostic to predict their efficacy.

Innovation Solution

A method and kit for predicting the efficacy of immunotherapeutic agents by measuring the expression level of CD86 in a biological sample, using a substance that specifically binds to CD86 or primers for amplifying CD86 nucleic acid, to evaluate the potential efficacy of treatments for mucosal lesions such as HPV infections or tumors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If immunotherapeutic agents are used to treat HPV infection and HPV-related tumors, then the ability to induce anti-HPV-specific immunity is improved, but the correlation with clinical therapeutic effect remains unclear and therapeutic effect on CIN is limited

Engineering Contradiction:
Improveability to induce anti-HPV-specific immunityVSAvoidcorrelation with clinical therapeutic effect
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent performs preliminary measurement of CD86 expression levels in biological samples before initiating immunotherapeutic treatment. This preliminary action allows prediction of treatment efficacy in advance, enabling selection of appropriate patients who are more likely to respond to immunotherapy, thereby improving the correlation between treatment administration and clinical outcome.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If intramuscular injection is used to induce systemic immunity, then systemic immunity is improved, but a gap is created between the therapeutic drug and the local environment of the cervix with CIN lesion

Engineering Contradiction:
Improvesystemic immunityVSAvoidadaptation to local mucosal environment
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent measures CD86 expression levels specifically in cervical biological samples (such as cervical swabs or biopsy specimens) to assess the local immune environment at the cervix. This local measurement approach allows evaluation of how well the immunotherapeutic agent adapts to and acts on the specific mucosal environment of the cervix, rather than only assessing systemic immune response.

Inventive Principle:
Principle #3Local quality

3Productivity

If immunotherapeutic agents are administered to all patients with CIN, then treatment coverage is improved, but ineffective treatments are administered to patients who will not respond

Engineering Contradiction:
Improvetreatment coverageVSAvoidineffective treatments
Core Design Contradiction:
ProductivityVSLoss of energy

Solution Approach 1:

The patent performs preliminary assessment of CD86 expression levels in cervical samples before administering immunotherapeutic agents. Patients are stratified into high-risk groups (with CD86 expression above a predetermined threshold) who are more likely to respond to treatment. This preliminary screening enables targeted treatment administration, improving overall treatment effectiveness while reducing waste of medical resources on patients unlikely to benefit.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP4632381A1Method and kit for predicting efficacy of treatment with immunotherapeutic agent on patient with mucosal lesion
Publication Date: 2025.10.15 GLOVACC CO LTD
  • EP4632381A1 patent drawingFigure 1
  • EP4632381A1 patent drawingFigure 2
  • EP4632381A1 patent drawingFigure 3

AI summary

The present invention provides a novel method and a novel kit for predicting the efficacy of a treatment with immunotherapeutic agent on a patient with mucosal lesion. The present invention is a method for predicting the efficacy of a treatment with immunotherapeutic agent on a patient with mucosal lesion, the method including a step of measuring an expression level of CD86 in a biological sample derived from the patient with mucosal lesion. The present invention is a kit for use in the method, the kit including a substance that specifically binds to CD86, or a forward primer and a reverse primer for amplifying a nucleic acid that encodes CD86.