Tumor PD-L1 and CLEVER-1 Screening for Anti-CLEVER-1 Therapy
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Solution Overview
Problem
Current immunotherapies targeting CTLA-4 and the PD-1/PD-L1 axis are ineffective for the majority of cancer patients, necessitating a method to identify those who will respond to alternative therapies like anti-CLEVER-1 treatment.
Innovation Solution
A method using immunohistochemistry staining to assess the ratio of PD-L1 and CLEVER-1 expressions in tumor biopsies prior to treatment, specifically identifying patients with low PD-L1 and high CLEVER-1 expression as candidates for anti-CLEVER-1 therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If checkpoint inhibitors targeting CTLA-4 and PD-1/PD-L1 axis are used, then treatment efficacy is improved in 10-20% of patients, but the majority of patients do not respond
Solution Approach 1:
The patent applies preliminary action by performing immunohistochemistry staining of tumor biopsies before treatment to assess PD-L1 and CLEVER-1 expressions. This pre-treatment evaluation identifies patients with low PD-L1 and high CLEVER-1 expression who are likely to respond to anti-CLEVER-1 therapy, allowing clinicians to select appropriate patients before administering treatment and avoiding unnecessary treatments for non-responders.
2Productivity
If anti-CLEVER-1 therapy is administered without patient selection, then all patients receive treatment, but many undergo unnecessary treatments reducing overall efficacy
Solution Approach 1:
The patent implements preliminary action through pre-treatment immunohistochemistry staining that assesses PD-L1 and CLEVER-1 expressions in tumor biopsies. This screening identifies patients with the specific biomarker profile (low PD-L1, high CLEVER-1) who are likely to benefit from anti-CLEVER-1 therapy, enabling clinicians to prescribe treatment only to appropriate patients and avoid unnecessary treatments for others.
Solution Approach 2:
The patent applies feedback by using the results of immunohistochemistry staining (PD-L1 and CLEVER-1 expression levels) to guide treatment decisions. The biomarker assessment provides feedback on patient eligibility, allowing clinicians to adjust treatment plans based on individual patient characteristics and improve overall treatment efficiency.
3Measurement precision
If immunohistochemistry staining is performed to assess PD-L1 and CLEVER-1 expressions, then patient selection accuracy is improved, but additional testing time and complexity are required
Solution Approach 1:
The patent applies merging by combining the assessment of two biomarkers (PD-L1 and CLEVER-1) into a single immunohistochemistry staining procedure performed on the same tumor biopsy sample. This integrated approach evaluates both expressions simultaneously, improving patient selection accuracy while avoiding the need for separate testing procedures and reducing overall testing complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach accurately selects patients likely to benefit from anti-CLEVER-1 treatment, reducing unnecessary treatments and enhancing treatment response.
Implementation Method 1
detecting the presence of PD-L1 expressing cells and CLEVER-1 expressing cells in the tumor sample by immunohistochemistry staining
Data Source
AI summary
A method for pre-treatment identification of cancer patients that respond to anti-CLEVER-1 therapy comprising an administration of an agent capable of binding to CLEVER-1 in a patient. In the method. the presence of PD-L1 expressing cells and CLEVER-1 expressing cells is detected in a tumor sample obtained from a cancer patient. by immunohistochemistry staining by a PD-L1 specific antibody and a mouse monoclonal lgG2a kappa STAB-1 antibody (clone 4G9), and then a percentage of PD-L1 expressing cells from the total amount of viable cells present in the stained sample, and a percentage of intra-tumoral CLEVER-1 expressing cells from the total amount of viable intra-tumoral cells present in the stained sample. is calculated. A tumor sample which shows low percentage of PD-L1 expressing cells or not comprising PD-L1 expressing cells together with substantial percentage of CLEVER-1 expressing intra-tumoral cells is an indication that the cancer patient is responsive to the anti-CLEVER-1 therapy.