Rec2 AAV Vector Tissue-Specific Promoter Off-Target Expression

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Solution Overview

Problem

Current recombinant adeno-associated virus (rAAV) vectors have limited transduction efficiency for adipose tissue and often result in off-target transgene expression, leading to deleterious effects in non-specific tissues.

Innovation Solution

Development of a hybrid serotype Rec2 AAV vector with two expression cassettes, one containing a regulatory element and a transgene linked to a promoter, and the other with a tissue-specific promoter and RNA silencing element to target and restrict transgene expression to specific tissues, such as visceral adipose tissue, minimizing off-target effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If naturally occurring AAV serotypes are used for gene delivery, then transduction of adipose tissue can be achieved, but transduction efficiency is low

Engineering Contradiction:
Improvetransduction efficiencyVSAvoidtransduction effectiveness
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent modifies the AAV capsid parameters by creating hybrid serotypes (e.g., AAV2/8, AAV2/1) with altered surface properties that enable efficient adipose tissue transduction. These engineered capsids maintain the ability to transduce adipose tissue while achieving high transduction efficiency, resolving the contradiction between naturally occurring low efficiency and the need for reliable gene delivery.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If high dose viral vectors are used to achieve therapeutic effects in adipose tissue, then transduction efficiency improves, but off-target transduction in liver and other tissues increases causing deleterious effects

Engineering Contradiction:
Improvetransduction efficiencyVSAvoidoff-target deleterious effects
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent employs tissue-specific promoters (e.g., adipose-specific promoters) that confer localized gene expression properties to the transgene. This ensures that even when the viral vector transduces multiple tissue types, the therapeutic gene is expressed only in the target adipose tissue, eliminating off-target harmful effects while maintaining high transduction efficiency in the desired tissue.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent uses tissue-specific regulatory elements as intermediaries between the transduced cells and gene expression. These intermediaries (tissue-specific promoters and microRNAs) act as selective switches that allow gene expression only in adipose tissue, thereby permitting high doses of viral vectors to be used for effective adipose transduction without causing deleterious off-target effects in liver and other tissues.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If adipose tissue specific promoter or micro-RNA targeting sequence is used, then specific transduction of adipose tissue is achieved, but high dose is required to achieve therapeutic effects

Engineering Contradiction:
Improvespecificity of transductionVSAvoidtherapeutic effect achievement
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The patent creates composite viral vector systems that combine multiple functional elements: engineered capsids for efficient adipose entry, tissue-specific promoters for selective expression, and microRNA targeting sequences for additional specificity. This composite approach enhances both specificity and therapeutic efficacy, allowing lower doses to achieve therapeutic effects compared to using adipose-specific elements alone.

Inventive Principle:
Principle #40Composite materials

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 Rec2 vector achieves high transduction efficiency in visceral adipose tissue with minimal off-target expression in other tissues, effectively treating conditions like obesity, diabetes, and metabolic syndrome by delivering genes like leptin or IL-15, as demonstrated in mouse models.

Implementation Method 1

a RNA silencing element to target and restrict transgene expression to specific tissues

Methodology Applied
Scientific EffectRNA interference:

Data Source

PatentEP3600343B1Novel recombinant adeno-associated viral vectors restricting off-target transduction in liver and uses thereof
Publication Date: 2022.11.23 OHIO STATE INNOVATION FOUND
  • EP3600343B1 patent drawingFigure 1A~1B
  • EP3600343B1 patent drawingFigure 1C
  • EP3600343B1 patent drawingFigure 2A~2C

AI summary

Disclosed are compositions and methods related to novel adeno-associated virus vectors comprising two expression cassettes, wherein the first cassette comprises a regulatory element and a transgene operatively linked to a promoter; and wherein the second cassette comprises a liver specific promoter operatively linked to a microRNA that targets the regulatory element in the first expression cassette.