Ig-Aim Fusion Proteins for Selective Pathogenic B-Cell Erasure

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Solution Overview

Problem

Current therapeutic approaches for autoimmune diseases and B-cell related disorders target the entire B-cell population non-specifically, leading to the elimination of both pathogenic and non-pathogenic cells, resulting in immune deficiencies and inefficiencies, and there is a need for a method to selectively target and eliminate only pathogenic B cells.

Innovation Solution

Development of fusion proteins or conjugates, named cell surface Ig-Aimed immune memory erasers (Ig-Aim), which replace the receptor-binding domain of diphtheria toxin with surface immunoglobulin (slg) targeting peptides, such as SpA, SpG, or affibodies, to specifically target and eliminate slg+ B cells, including those expressing IgG, IgA, or IgE, without harming non-target B cells.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional therapies target the entire B-cell population, then pathogenic B cells are eliminated, but non-pathogenic B cells are also destroyed causing immune deficiency

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidimmune deficiency
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention segments the B-cell population into pathogenic (slg+) and non-pathogenic (slg-) subsets, using surface immunoglobulin expression as the dividing criterion. The fusion protein specifically targets slg+ B cells for elimination while leaving slg- B cells intact, thereby achieving therapeutic efficacy without causing broad immune deficiency.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The fusion protein exhibits local quality by having different functional properties for different B-cell subsets. It specifically binds to and kills slg+ B cells through the slg-targeting domain, while having no effect on slg- B cells. This localized action allows selective elimination of pathogenic cells without harming healthy B cells.

Inventive Principle:
Principle #3Local quality

2Adaptability or versatility

If non-specific B-cell targeting is used, then treatment coverage is comprehensive, but therapeutic precision is low

Engineering Contradiction:
Improvetreatment coverageVSAvoidtherapeutic precision
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The fusion protein uses surface immunoglobulin (slg) as an intermediary marker to identify and target pathogenic B cells. By coupling the slg-targeting domain with the cytotoxic diphtheria toxin A fragment, the invention creates a mediator that specifically delivers the killing effect only to slg+ cells, achieving high therapeutic precision while maintaining comprehensive coverage of pathogenic B-cell disorders.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The fusion protein exhibits local quality by having different functional properties for different B-cell subsets. It specifically binds to and kills slg+ B cells through the slg-targeting domain, while having no effect on slg- B cells. This localized action allows selective elimination of pathogenic cells without harming healthy B cells.

Inventive Principle:
Principle #3Local quality

3Power

If diphtheria toxin is used directly, then cytotoxicity is high, but specificity is low causing off-target effects

Engineering Contradiction:
ImprovecytotoxicityVSAvoidtarget specificity
Core Design Contradiction:
PowerVSMeasurement precision

Solution Approach 1:

The invention merges two distinct functional domains into a single fusion protein: the slg-targeting domain (such as SpA, SpG, or affibody) that provides specificity for binding to surface immunoglobulin on pathogenic B cells, and the diphtheria toxin A fragment that provides potent cytotoxicity. This combination ensures that the high-power cytotoxic effect is delivered only to slg+ target cells, eliminating off-target effects.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The fusion protein uses surface immunoglobulin (slg) as an intermediary marker to identify and target pathogenic B cells. By coupling the slg-targeting domain with the cytotoxic diphtheria toxin A fragment, the invention creates a mediator that specifically delivers the killing effect only to slg+ cells, achieving high therapeutic precision while maintaining comprehensive coverage of pathogenic B-cell disorders.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

The fusion proteins effectively kill 90-99% of target B cells while sparing non-pathogenic cells, providing a safe and specific therapeutic option for autoimmune diseases and B-cell disorders.

Implementation Method 1

The A fragment (N-terminal) of diphtheria toxin (DtA) contains a catalytic domain that disrupts protein synthesis in eukaryotic cells resulting in cytotoxicity in susceptible cells

Methodology Applied
Scientific EffectProtein synthesis disruption:

Implementation Method 2

The variable regions of antibodies are generated by V(D)J recombination and further modified by somatic hypermutation, resulting in increased affinity following exposure to antigens

Methodology Applied
Scientific EffectAntibody-antigen binding:

Implementation Method 3

B cells can also employ endocytosis when exposed to an antigen. This can occur when a membrane-bound immunoglobulin on the B cell's surface is exposed to a specific antigen. The antibody-antigen complex is then internalized and degraded.

Methodology Applied
Scientific EffectEndocytosis:

Data Source

PatentEP4647081A1Cell surface ig-aimed immune memory erasers and uses thereof
Publication Date: 2025.11.12 ARAKAWA HIROSHI
  • EP4647081A1 patent drawingFigure 1A~1C
  • EP4647081A1 patent drawingFigure 1D~1F
  • EP4647081A1 patent drawingFigure 2A~2C

AI summary

The present invention refers to a fusion protein or conjugate comprising or consisting of: a) a Diphtheria toxin deprived of the receptor binding domain or functional fragments or derivatives or a biologically active variant thereof; and b) at least one surface immunoglobulin (slg) B-cell targeting peptide or functional fragments or derivatives or a biologically active variant thereof. Isolated nucleic acids, vectors and pharmaceutical compositions related to said fusion protein, as well as their medical uses, are also objects of the invention.