AAV Vector Antisense Oligonucleotide Exon 53 Skipping

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Solution Overview

Problem

Current gene therapy approaches for Duchenne muscular dystrophy (DMD) face challenges in stably introducing antisense oligonucleotides into muscle fibers, with existing methods requiring frequent injections and potential toxicity at high doses, and the complexity of choosing effective antisense sequences for exon skipping.

Innovation Solution

A recombinant adeno-associated viral vector (AAVr) carrying a judiciously chosen antisense oligonucleotide (AON) targeting exon 53 of the dystrophin gene, combined with a modified snRNA, to efficiently skip exon 53 and produce a truncated but functional dystrophin protein.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If naked antisense oligonucleotides are directly injected, then the treatment can be administered, but frequent injections are required due to short lifespan in muscle

Engineering Contradiction:
Improvelifespan of antisense oligonucleotide in muscleVSAvoidfrequency of injections required
Core Design Contradiction:
Duration of action of moving objectVSProductivity

Solution Approach 1:

The patent uses chemical modifications (2'-O-methyl, phosphorothioate backbone) as intermediary structures that protect the antisense oligonucleotide from degradation by nucleases in the muscle tissue, thereby extending its lifespan and reducing injection frequency

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs chemically modified oligonucleotides that are more stable and longer-lasting in the muscle tissue, replacing the need for frequent administrations of naked oligonucleotides

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Stability of the object's composition

If chemically modified oligonucleotides are used at high doses, then stability in vivo is improved, but toxicity increases

Engineering Contradiction:
Improvestability of oligonucleotide in vivoVSAvoidtoxicity at high doses
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent optimizes the chemical structure parameters of the oligonucleotide (2'-O-methyl modifications, phosphorothioate backbone) to achieve the right balance between stability and reduced toxicity, allowing effective doses with improved safety profile

Inventive Principle:
Principle #35Parameter changes

3Duration of action of stationary object

If recombinant adeno-associated viral vectors are used, then long-term expression is achieved, but the complexity of vector design and production increases

Engineering Contradiction:
Improveduration of dystrophin expressionVSAvoidcomplexity of viral vector system
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

The patent uses recombinant adeno-associated viral vectors that are pre-designed to carry the antisense oligonucleotide sequence, enabling long-term stable expression of dystrophin exon 53 skip variants with a single administration

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The AAV vector serves as an intermediary delivery system that protects the oligonucleotide sequence and facilitates its long-term expression in muscle tissue, overcoming the limitations of direct injection

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If exon skipping strategy is applied, then reading frame is restored, but the complexity of selecting effective antisense sequences increases

Engineering Contradiction:
Improverestoration of reading frameVSAvoidcomplexity of antisense sequence selection
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent targets specific local regions within exon 53 (such as the 5' or 3' portions) with designed antisense oligonucleotides, achieving effective reading frame restoration while simplifying the selection process by focusing on critical splicing regulatory regions

Inventive Principle:
Principle #3Local quality

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 achieves long-term expression of a truncated dystrophin protein, providing a promising therapeutic tool for DMD by optimizing the delivery and stability of AONs, reducing the need for frequent injections and minimizing toxicity.

Implementation Method 1

l'oligonucléotide antisens est dirigé contre un segment d'au moins 33 bases de la région +30 à +69 de l'exon 53 de l'ARN pré-messager de la dystrophine

Methodology Applied
Scientific EffectHybridization:

Data Source

PatentEP3387130B1Efficient gene therapy tools for exon 53 skipping of the dystrophin gene
Publication Date: 2020.11.11 GENETHON
  • EP3387130B1 patent drawingFigure 1~2
  • EP3387130B1 patent drawingFigure 3
  • EP3387130B1 patent drawingFigure 4A~4B

AI summary

The invention relates to a recombinant adeno-associated viral vector (rAAV) comprising a sequence encoding an antisense oligonucleotide (AON) directed against a segment of at least 33 bases from the +30 to +69 region of exon 53 of the pre-messenger RNA (pre-mRNA) of dystrophin, advantageously of human origin, and to the use thereof as a drug, in particular for the treatment of Duchenne muscular dystrophy (DMD).