Soluble CD26 Biomarker for Early Anti-CD26 Treatment Response
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
There is a lack of serum biomarkers that indicate treatment outcome during cancer therapy, particularly for anti-CD26 antibody treatments, necessitating a faster and more reliable method to assess therapeutic efficacy.
Innovation Solution
The correlation between serum soluble CD26/DPP4 titer variation and treatment efficacy is established by analyzing changes in soluble CD26 levels during a first cycle of YS110 administration, using response criteria and progression-free survival to identify prognostic biomarkers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If RECIST criteria are used to determine therapeutic effect, then assessment reliability is improved, but assessment time is extended to four weeks
Solution Approach 1:
The patent applies preliminary action by measuring soluble CD26 levels at baseline (before treatment) and at early time points (e.g., day 7, day 14) during treatment to predict therapeutic response before the standard four-week RECIST assessment. This allows early identification of treatment efficacy without waiting for tumor size changes to become apparent.
Solution Approach 2:
The patent implements feedback by using soluble CD26 level changes as a biomarker to provide real-time information about treatment response. The variation in soluble CD26 levels feeds back to clinicians, enabling them to assess therapeutic effect dynamically and adjust treatment strategies based on biomarker trends rather than waiting for delayed imaging assessments.
2Productivity
If serum soluble CD26 titer is used as biomarker, then assessment speed is improved, but biomarker reliability for predicting treatment outcome is insufficient
Solution Approach 1:
The patent applies parameter changes by analyzing the variation (change) in soluble CD26 titers from baseline to during treatment, rather than relying on absolute titer values. The patent specifically examines the magnitude and direction of titer changes to correlate with treatment response, transforming the biomarker from a static measurement to a dynamic parameter that reflects treatment efficacy.
Solution Approach 2:
The patent implements dynamics by tracking the temporal pattern of soluble CD26 level changes throughout treatment. Rather than a single measurement, the patent monitors how soluble CD26 levels evolve over time (increasing, decreasing, stabilizing), using these dynamic patterns to predict treatment outcome and correlate with RECIST response criteria.
Data Source
AI summary
Potential prognostic biomarkers for CD26-targeted therapy were identified based on phase I study data of a humanized anti-CD26 monoclonal antibody YS110 against CD26-expressing tumors. Using boxplot analysis, scatter plot analysis, Pearson's product-moment correlation/Spearman's rank-difference correlation, bar graph analysis, and receiver operating characteristic (ROC), a correlation between soluble CD26 titer variation and tumor volume variation by YS110 administration, RECIST criteria evaluation, and progression-free survival (PFS) were examined. Further, mechanism of serum soluble CD26 titer variation was confirmed by in vitro experiments. As a result, serum soluble CD26/DPP4 titer variation at an early stage of YS110 treatment was found for the first time as a predictive biomarker to evaluate a therapeutic effect.