Multivalent Antigen-Binding Fv Molecule Domain Order

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Solution Overview

Problem

Current tandem diabodies with the domain order V H A-V L B-V H B-V L A have limitations in biological activity and therapeutic efficacy, necessitating an improved antigen-binding molecule with enhanced cytotoxicity and reduced dosages for immunotherapy applications.

Innovation Solution

A dimeric antigen-binding molecule with the domain order V L A-V H B-V L B-V H A is developed, comprising two polypeptide chains with specific variable domains arranged to form tetravalent, bispecific antigen-binding sites, enhancing biological activity and cytotoxicity by modified crosslinking and antigen binding efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the domain order V H A-V L B-V H B-V L A is used in tandem diabodies, then the molecule can be constructed with standard intermolecular pairing, but the biological activity and cytotoxicity are limited

Engineering Contradiction:
Improvebiological activityVSAvoiddomain arrangement complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent inverts the conventional domain arrangement by placing the light chain variable domain (V L A) at the N-terminus followed by the heavy chain variable domain (V H B), then light chain (V L B) and heavy chain (V H A) at the C-terminus. This reversed sequence arrangement (V L A-V H B-V L B-V H A) fundamentally changes the molecular architecture to achieve superior biological activity and cytotoxicity compared to the standard V H A-V L B-V H B-V L A configuration.

Inventive Principle:
Principle #13The other way round (Inversion)

2Productivity

If the conventional V H A-V L B-V H B-V L A domain order is used, then the tandem diabody can be produced with standard protocols, but higher dosages are required for therapeutic efficacy

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidtherapeutic dosage
Core Design Contradiction:
ProductivityVSQuantity of substance

Solution Approach 1:

The patent changes the fundamental parameter of domain sequence arrangement from the conventional V H A-V L B-V H B-V L A to the inverted V L A-V H B-V L B-V H A. This parameter change in the molecular architecture results in enhanced cytotoxic activity and therapeutic efficacy, allowing for reduced dosages while maintaining or improving treatment effectiveness.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If standard tandem diabody construction is used, then the molecule has four antigen-binding sites, but the crosslinking efficiency and antigen binding capability are insufficient

Engineering Contradiction:
Improveantigen binding efficiencyVSAvoidcrosslinking structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces asymmetry in the domain arrangement by alternating light chain and heavy chain domains in a specific sequence (V L A-V H B-V L B-V H A). This asymmetric arrangement creates optimized crosslinking patterns that enhance antigen binding efficiency and molecular stability, improving the functional performance of the tetravalent structure.

Inventive Principle:
Principle #4Asymmetry

Data Source

PatentEP2371866B1Multivalent antigen-binding Fv molecule
Publication Date: 2018.11.21 AFFIMED GMBH
  • EP2371866B1 patent drawingFigure 1~2(C)
  • EP2371866B1 patent drawingFigure 3~4
  • EP2371866B1 patent drawingFigure 5

AI summary

In one aspect, the present invention relates to an antigen-binding molecule comprising two polypeptide chains, each polypeptide chain having at least four variable domains in an orientation preventing Fv formation and the two polypeptide chains are dimerized with one another thereby forming a multivalent antigen-binding molecule. On each of the two polypeptide chains the four variable domains are arranged in the order V L A-V H B-V L B-V H A from the N-terminal to the C-terminal of the polypeptide.. Compositions of the antigen-binding molecule and the methods of using the antigen-binding molecule or the compositions thereof for treatment of various diseases are also provided herein.