Endothelial Biomarker Stratification for IECT Side Effect Risk
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Solution Overview
Problem
Current methods lack effective tools to predict and manage the risk and severity of side effects, such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), associated with immune effector cell therapies (IECT) in cancer patients, particularly due to the limited understanding of endothelial dysfunction markers before and after therapy.
Innovation Solution
Determine the level of endothelial dysfunction biomarkers, such as proADM or its fragments, in bodily fluids to predict the risk and severity of side effects and assess the effectiveness of treatments, enabling patient stratification and targeted immunosuppressive therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If immune effector cell therapy is administered to cancer patients, then treatment efficacy is improved, but the risk and severity of side effects such as CRS and ICANS increase
Solution Approach 1:
The patent applies preliminary action by measuring endothelial dysfunction biomarkers (such as sPECAM-1, sICAM-1, sVCAM-1, vWF, and ADAMTS13) before IECT administration to identify patients at high risk for CRS and ICANS. This pre-screening enables proactive risk stratification and preventive intervention strategies, allowing clinicians to prepare appropriate prophylactic measures or adjust treatment protocols before the therapy is administered, thereby reducing the likelihood or severity of adverse events while maintaining treatment efficacy.
2Productivity
If all cancer patients receive IECT treatment, then more patients may benefit from effective therapy, but more patients are exposed to potential severe side effects
Solution Approach 1:
The patent applies local quality by implementing risk-stratified treatment approaches based on individual patient biomarker profiles. Instead of uniform treatment for all patients, the method identifies specific subgroups with elevated endothelial dysfunction markers who are at higher risk for CRS and ICANS. This enables tailored intervention strategies—such as enhanced monitoring, prophylactic immunosuppression, or adjusted dosing—for high-risk patients, while standard treatment can be maintained for low-risk patients, thereby optimizing the benefit-risk ratio across the entire patient population.
3Measurement precision
If biomarker testing is performed on all patients, then accurate risk prediction is achieved, but testing costs and complexity increase
Solution Approach 1:
The patent applies segmentation by dividing the biomarker panel into multiple individual tests that can be performed separately or in combination. Rather than requiring a complex comprehensive panel for all patients, the method allows clinicians to select specific biomarkers (such as sPECAM-1, sICAM-1, sVCAM-1, vWF, or ADAMTS13) based on patient-specific risk factors, clinical presentation, and resource availability. This modular approach maintains prediction accuracy for high-risk patients while reducing testing complexity and cost for lower-risk individuals.
Data Source
AI summary
The present application is directed to a method for the prediction of a risk of side effects and/or prediction of the severity of side effects in a cancer patient that is to be treated or has been treated with immune effector cells in the frame of an immune effector cell therapy (IECT), and/or for assessing an effect of a treatment of side effects in a cancer patient that has been treated with immune effector cells in the frame of an IECT, the method comprising the steps of a) determining the level of at least one endothelial dysfunction biomarker in a sample of bodily fluid of the patient, and b) correlating the level of the at least one endothelial dysfunction biomarker in the sample to the risk of the side effects and/or the severity of the side effects in the patient and/or to the effect of the treatment of the side effects in the patient. Further aspects relate to corresponding methods stratification and medicaments for use in corresponding treatment.