HLA Marker Analysis for Predicting Anti-Tumor Therapy Response
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Solution Overview
Problem
Current cancer treatments face challenges in predicting patient response due to tumor heterogeneity, leading to ineffective therapies and the need for new approaches to determine which patients will benefit from immunotherapy, chemotherapy, anti-hormonal therapy, or anti-tyrosin kinase therapy.
Innovation Solution
A method involving the determination of specific nucleic acid and protein levels, such as HLA-G, HLA-L, HLA-H, and HLA-J, in tumor samples to predict patient response by comparing these levels to predetermined standards, indicating whether a patient will respond or not respond to these therapies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional cancer treatments are used without predictive markers, then treatment options are limited and patient response is uncertain, but this leads to ineffective therapies and wasted resources
Solution Approach 1:
The patent applies preliminary action by measuring HLA-G, HLA-L, HLA-H, and HLA-J nucleic acid levels in tumor samples before initiating cancer therapy. This predictive measurement is performed in advance to determine patient response likelihood, allowing clinicians to select appropriate treatments before treatment begins, thereby avoiding ineffective therapies and wasted resources.
2Adaptability or versatility
If tumor heterogeneity is present, then treatment effectiveness varies among patients, but this makes predicting individual response difficult
Solution Approach 1:
The patent applies local quality by focusing measurement on specific local markers (HLA-G, HLA-L, HLA-H, HLA-J) within the tumor sample that are particularly associated with immune response and treatment effectiveness. By targeting these specific local molecular characteristics rather than attempting to measure all tumor heterogeneity, the method achieves precise prediction of individual patient response while accommodating the complexity of tumor diversity.
3Adaptability or versatility
If multiple therapy types are available, then treatment options increase, but determining the right therapy becomes more complex
Solution Approach 1:
The patent applies the intermediary principle by introducing HLA marker level measurement as a mediator between the patient's tumor characteristics and treatment selection. This intermediary measurement system simplifies the complex decision-making process by providing objective, quantifiable data (HLA-G, HLA-L, HLA-H, HLA-J levels) that directly indicates treatment response likelihood, making it easier to select appropriate therapies from multiple options.
Data Source
AI summary
The present invention relates to a method for predicting whether a subject having a tumor responds to a tumor therapy selected from (i) an immunotherapy, (ii) a chemotherapy, (iii) an anti-hormonal therapy, and (iv) an anti-tyrosin kinase therapy, wherein the method comprises (A) determining the level(s) of at least one nucleic acid molecule and/or at least one protein or peptide in a sample obtained from said subject, wherein the at least one nucleic acid molecule is selected from nucleic acid molecules (a) encoding a polypeptide comprising or consisting of the amino acid sequence of any one of SEQ ID NOs 1 to 6, (b) consisting of the nucleotide sequence of any one of SEQ ID NOs 7 to 12, (c) encoding a polypeptide which is at least 85% identical, preferably at least 90% identical, and most preferred at least 95% identical to the amino acid sequence of (a), (d) consisting of a nucleotide sequence which is at least 95% identical, preferably at least 96% identical, and most preferred at least 98% identical to the nucleotide sequence of (b), (e) consisting of a nucleotide sequence which is degenerate with respect to the nucleic acid molecule of (d), (f) consisting of a fragment of the nucleic acid molecule of any one of (a) to (e), said fragment comprising at least 150 nucleotides, preferably at least 300 nucleotides, more preferably at least 450 nucleotides, and most preferably at least 600 nucleotides, and (g) corresponding to the nucleic acid molecule of any one of (a) to (f), wherein T is replaced by U, and wherein the at least one protein or peptide is selected from proteins or peptides being encoded by the nucleic acid molecule of any one of (a) to (g); and (B) comparing the level(s) of (A) with the level(s) of the at least one nucleic acid molecule and/or the at least one protein or peptide in a sample obtained from one or more subjects that responded to one or more of the therapies of (i) to (ii) or a corresponding pre-determined standard, wherein increased level(s) of (A) as compared to the level(s) or pre-determined standard of (B) indicate(s) that the subject will not respond to the tumor therapy and substantially the same or decreased level(s) of (A) as compared to the level(s) of (B) indicate(s) that the subject will respond to the tumor therapy; or (B′) comparing the level(s) of (A) with the level(s) of the at least one nucleic acid molecule and/or the at least one protein or peptide in a sample obtained from one or more subjects that did not respond to one or more of the therapies of (i) to (iii) or a corresponding pre-determined standard, wherein decreased level(s) of (A) as compared to the level(s) or pre-determined standard of (B′) indicate(s) that the subject will respond to the tumor therapy and substantially the same or increased level(s) of (A) as compared to the level(s) of (B′) indicate(s) that the subject will not respond to the tumor therapy.