Promiscuous HER-2/Neu Epitopes for Broad HLA Coverage

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Solution Overview

Problem

Current cancer immunotherapies and vaccines are limited by the HLA-restriction of peptide epitopes, which confine their applicability to only a small percentage of the population, as they typically form productive peptide-MHC complexes with a small number of HLA alleles, restricting their use to individuals expressing those specific alleles.

Innovation Solution

Identification and utilization of novel promiscuous T cell epitopes within the HER-2/Neu protein sequence, specifically located between amino acids 270-284, which can be presented by at least 25 different HLA-DRB1 alleles, allowing for a universal CD4 T helper cell epitope that can induce a HER-2/Neu-specific immune response across various HLA types, using peptides such as TYNTDTFESMPN, ALVTYNTDTFESMPN, and others, either alone or fused with heterologous polypeptides like GM-CSF.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional peptide epitopes are used in cancer immunotherapies, then T cell recognition of HER-2/Neu can be achieved, but the applicability is limited to only a small percentage of the population due to HLA-restriction

Engineering Contradiction:
Improveapplicability of immunotherapy across populationVSAvoidT cell response consistency
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent identifies promiscuous T cell epitopes within the HER-2/Neu protein that can be presented by multiple HLA-DRB1 alleles (at least 25 different alleles). These epitopes, located in the region of amino acids 270-284, serve as universal CD4 T helper cell epitopes that can induce T cell responses across diverse HLA types, making the immunotherapy applicable to a much larger portion of the population while maintaining reliable T cell recognition.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If peptide epitopes are designed to be specific to certain HLA alleles, then T cell response can be reliably induced in HLA-matched individuals, but the therapy cannot be widely applied to the general population

Engineering Contradiction:
ImproveT cell response consistencyVSAvoidapplicability across HLA types
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent employs promiscuous epitopes that maintain the ability to bind to and present on at least 25 different HLA-DRB1 alleles. This multi-functionality allows a single epitope design to elicit reliable T cell responses across diverse HLA backgrounds, resolving the contradiction between specificity and versatility by finding epitopes that are both reliably recognized and widely applicable.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Measurement precision

If HLA-restricted epitopes are used, then immune response can be precisely targeted to specific HLA types, but the scope of clinical trial participation is confined to 20% or less of the general population

Engineering Contradiction:
Improvedetection of HLA-restricted responseVSAvoidscope of population inclusion
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The patent identifies epitopes within the HER-2/Neu protein (amino acids 270-284) that serve as universal markers. These epitopes can be detected and measured across individuals with different HLA types, allowing precise measurement of immune response while expanding the scope of clinical trials to include the general population rather than being confined to a narrow HLA-matched cohort.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP2570422B1Promiscuous HER-2/NEU CD4 T cell epitopes
Publication Date: 2015.12.16 DENDREON PHARMACEUTICALS INC
  • EP2570422B1 patent drawingFigure 1A~1B
  • EP2570422B1 patent drawingFigure 2
  • EP2570422B1 patent drawingFigure 3

AI summary

The present invention relates to the discovery of novel T cell epitopes of the human HER-2/Neu protein that is promiscuous for at least 25 different HLA-DR alleles. The invention also relates to compositions that contain one of the novel epitopes or a fusion peptide of such a epitope and a heterologous polypeptide. Further disclosed herein is the use of the epitopes or their fusion peptides, and compositions containing the epitopes or their fusion peptides.