Protease-Activatable T Cell Bispecific Molecules

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Solution Overview

Problem

Current bispecific molecules used in cancer therapy often activate T cells non-specifically, leading to toxicity in both target and non-target cells, as they do not require proximity to the target cell for activation, which can result in damage to healthy tissues.

Innovation Solution

Development of protease-activatable T cell activating bispecific molecules with a masking moiety that conceals the CD3-binding site until proximity to a target cell is achieved, utilizing a protease-cleavable linker and anti-idiotypic scFv to mask the antigen-binding moieties, ensuring activation only in the presence of the target cell.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If bispecific molecules are used to activate T cells against target cells, then immune response against tumor is improved, but toxicity to healthy tissues occurs due to non-specific activation

Engineering Contradiction:
Improvespecificity of T cell activationVSAvoidtoxicity to healthy tissues
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by pre-masked the CD3-binding site with an anti-idiotypic antibody before administration. The bispecific molecule is designed with the CD3-binding site already concealed, and activation only occurs when the molecule reaches the target tissue and is cleaved by proteases. This preliminary masking prevents premature or non-specific T cell activation in healthy tissues, thereby reducing toxicity while maintaining the ability to activate T cells against tumor cells.

Inventive Principle:
Principle #10Preliminary action

2Productivity

If CD3-binding site is exposed to activate T cells, then T cell activation efficiency is improved, but non-specific binding to healthy cells increases

Engineering Contradiction:
ImproveT cell activation efficiencyVSAvoidnon-specific binding to healthy cells
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent uses an anti-idiotypic antibody as an intermediary to mask the CD3-binding site. This masking moiety acts as a temporary barrier that prevents direct interaction between the CD3-binding site and CD3 molecules on T cells. The masking is reversible through protease cleavage, which occurs specifically in the target tissue environment. This intermediary approach allows the molecule to circulate safely without activating T cells non-specifically, while still enabling efficient T cell activation when and where needed.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If masking moiety is added to conceal CD3-binding site, then specificity of activation is improved, but molecular complexity increases

Engineering Contradiction:
Improveselectivity of T cell activationVSAvoidstructure of bispecific molecule
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple functional elements into a single integrated bispecific molecule structure. The CD3-specific binding moiety, target cell antigen-binding moiety, and anti-idiotypic masking moiety are all incorporated into one molecular construct. This merging approach allows the molecule to perform multiple functions (targeting, masking, and activation) simultaneously, reducing the need for separate components and simplifying the overall therapeutic approach while maintaining high selectivity.

Inventive Principle:
Principle #5Merging (Combining)

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 selectively activates T cells only when in close proximity to target cells, reducing toxicity to healthy tissues by maintaining the CD3-binding site in a masked state until the protease is activated by the target cell, thereby enhancing the specificity and efficacy of cancer therapy.

Implementation Method 1

a protease-cleavable linker, wherein the masking moiety is capable of specific binding to the idiotype of the first or the second antigen binding moiety thereby reversibly concealing the first or second antigen binding moiety

Methodology Applied
Scientific EffectProteolytic cleavage: Enzyme

Data Source

PatentEP3433280B1Protease-activated t cell bispecific molecules
Publication Date: 2023.04.19 F HOFFMANN LA ROCHE & CO AG
  • EP3433280B1 patent drawingFigure 1A
  • EP3433280B1 patent drawingFigure 1B
  • EP3433280B1 patent drawingFigure 1C

AI summary

The present invention generally relates to novel protease-activatable T cell activating bispecific molecules and idiotype-specific polypeptides acting as masking moieties. The present invention also relates to polynucleotides encoding such protease-activatable T cell activating bispecific molecules and idiotype-specific polypeptides, and vectors and host cells comprising such polynucleotides. The invention further relates to methods for producing the protease-activatable T cell activating bispecific molecules and idiotype-specific polypeptides of the invention, and to methods of using these protease-activatable T cell activating bispecific molecules and idiotype-specific polypeptides in the treatment of disease.