Self-Immolative Linker for Antibody-Drug Conjugate Stability

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Solution Overview

Problem

Current antibody-drug conjugate (ADC) linkers, particularly cleavable and non-cleavable types, face instability issues which can lead to premature drug dissociation before reaching target cancer cells, affecting the efficacy and safety of cancer treatment.

Innovation Solution

A ligand-drug conjugate design featuring a linker that includes a peptide with hydrophilic amino acids and an oxime linkage, which enhances stability and targeted drug release through enzymatic cleavage, utilizing a biomolecule reaction with a prodrug and alkoxyamine to form a covalent oxime bond.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a disulfide bond linker is used to allow dissociation via thiol exchange reaction, then the antibody-drug conjugate can release drug in reducing environment, but the drug may dissociate from the antibody prior to reaching its target due to presence of thiols in blood

Engineering Contradiction:
Improvedrug release capabilityVSAvoidlinker stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent introduces a self-immolative group as an intermediary component between the antibody and the drug. This self-immolative group contains a specific peptide sequence that is recognized and cleaved by lysosomal enzymes after the ADC is internalized into the target cell. The self-immolative group then undergoes spontaneous decomposition to release the active drug, thereby mediating the transition from a stable conjugate to active drug release while preventing premature dissociation in circulation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If a thiol-maleimide method is used to attach drug to antibody, then the attachment is achieved, but the antibody-drug conjugate is unstable and drug may dissociate before or after reaching target cell

Engineering Contradiction:
Improveconjugate formationVSAvoidconjugate stability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent changes the chemical parameters of the linker by incorporating a self-immolative group with specific chemical properties. The self-immolative group contains a cleavable peptide bond that is stable under physiological conditions but can be selectively hydrolyzed by lysosomal enzymes at pH 5.0-5.5. This parameter change transforms the linker from one that is unstable in circulation to one that is stable in circulation but releases drug intracellularly.

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If non-cleavable linkers are used to attach drug to antibody, then the drug cannot dissociate prematurely, but the pendant drug generally cannot dissociate from the antibody in vivo

Engineering Contradiction:
Improvelinker stabilityVSAvoiddrug release capability
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent segments the linker into two functional parts: a stable portion that maintains conjugate integrity in circulation and a self-immolative portion that enables intracellular drug release. The self-immolative group contains a peptide sequence that is cleaved by lysosomal enzymes, causing the linker to self-decompose and release the active drug. This segmentation allows the linker to simultaneously provide both stability and controlled release capability.

Inventive Principle:
Principle #1Segmentation

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 new linker design improves the stability and targeted delivery of the drug to cancer cells, reducing off-target effects and enhancing the therapeutic efficacy of ADCs.

Implementation Method 1

The linker ideally allows the drug to exhibit an effect on a target cancer cell, e.g., after being separated from the antibody (for example, by enzyme-mediated hydrolysis)

Methodology Applied
Scientific EffectEnzymatic hydrolysis: Hydrolysis

Implementation Method 2

A disulfide linker, which allows for dissociation via a thiol exchange reaction, relies in part on the uptake of an antibody-drug conjugate into a target cell and the exposure of the disulfide to the cytosol, which is a reducing environment

Methodology Applied
Scientific EffectThiol exchange reaction: Redox Reactions

Data Source

PatentEP3380124B1Conjugates comprising self-immolative groups and methods related thereto
Publication Date: 2024.04.03 LIGACHEM BIOSCIENCES INC
  • EP3380124B1 patent drawingFigure 1
  • EP3380124B1 patent drawingFigure 2
  • EP3380124B1 patent drawingFigure 3

AI summary

In some aspects, the invention relates to an antibody-drug conjugate, comprising an antibody; a linker; and an active agent. The antibody-drug conjugate may comprise a self- immolative group. The linker may comprise an O-substituted oxime, e.g., wherein the oxygen atom of the oxime is substituted with a group that covalently links the oxime to the active agent; and the carbon atom of the oxime is substituted with a group that covalently links the oxime to the antibody.