AAV Vector Segmentation for Large Microdystrophin Packaging

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Solution Overview

Problem

Current gene therapy vectors, such as Adeno-Associated Virus (AAV), face limitations in packaging DNA sequences larger than 5 kb, which is a challenge for effectively treating Duchenne and Becker muscular dystrophies due to the size constraints of the dystrophin gene, leading to truncated genomes and lower expression efficiency.

Innovation Solution

The development of AAV vectors that can package oversized DNA sequences encoding larger active microdystrophins, including those with extended central rod and C-terminal domains, allowing for the production of functional dystrophin proteins that exceed the traditional size limits, thereby addressing the packaging limitations and enhancing therapeutic potential.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If AAV vectors are used to deliver dystrophin gene therapy, then long-term gene transduction in muscle cells is achieved, but the cargo capacity limitation of around 5 kb prevents packaging of the full-length dystrophin gene

Engineering Contradiction:
Improvelong-term gene transductionVSAvoidcargo capacity
Core Design Contradiction:
ReliabilityVSVolume of stationary object

Solution Approach 1:

The dystrophin gene is divided into two separate expression cassettes: one encoding the N-terminal domain (exons 1-62) and another encoding the C-terminal domain (exons 63-79). Each cassette is packaged into a separate AAV vector, allowing both large functional domains to be delivered within the 5 kb cargo capacity limit while achieving long-term transduction in muscle cells.

Inventive Principle:
Principle #1Segmentation

2Adaptability or versatility

If oversized DNA sequences are packaged in AAV vectors, then larger microdystrophins encompassing rod and CT domains can be produced, but truncated packaged genomes and heterogeneous population result

Engineering Contradiction:
Improvemicrodystrophin variantsVSAvoidgenome integrity
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The oversized DNA sequence encoding microdystrophin with both rod and CT domains is segmented into two manageable cassettes that fit within AAV cargo capacity. This segmentation prevents genome truncation and heterogeneity while enabling production of larger, more functional microdystrophin variants that include previously excluded domains.

Inventive Principle:
Principle #1Segmentation

3Reliability

If the full-length dystrophin gene is targeted for therapy, then complete functional restoration is achieved, but the gene size of 2.5 Mb exceeds all current gene therapy vector systems

Engineering Contradiction:
Improvefunctional restorationVSAvoidgene size
Core Design Contradiction:
ReliabilityVSVolume of stationary object

Solution Approach 1:

The 2.5 Mb dystrophin gene is segmented into two strategic portions: the N-terminal cassette (exons 1-62) and C-terminal cassette (exons 63-79). Each cassette is packaged in a separate AAV vector, enabling delivery of the complete functional gene within the constraints of current vector systems while achieving reliable functional restoration in dystrophic muscle tissue.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3292138B1Production of large-sized microdystrophins in an AAV-based vector configuration
Publication Date: 2021.09.29 ROYAL HOLLOWAY & BEDFORD NEW COLLEGE
  • EP3292138B1 patent drawingFigure 1
  • EP3292138B1 patent drawingFigure 2
  • EP3292138B1 patent drawingFigure 3A~3B

AI summary

An adeno-associated viral (AAV) vector containing an expression construct, wherein: - the expression construct comprises a nucleic acid sequence which encodes a microdystrophin (MD); and - the nucleic acid sequence encoding the MD has a size of at least 4,1 kb.