Double-Stranded Antisense Nucleic Acid Complexes for Nuclear Delivery

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Solution Overview

Problem

Current nucleic acid drugs face challenges in delivering antisense oligonucleotides effectively into cell nuclei, particularly in achieving high specificity and efficiency for gene silencing and exon skipping applications.

Innovation Solution

Development of double-stranded nucleic acid complexes that include an antisense nucleic acid strand capable of inducing splice-switched variants of RNA, allowing for high specificity and efficiency in delivering antisense oligonucleotides into the nucleus, where they can modulate RNA processing and suppress target gene expression.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If single-stranded antisense oligonucleotides are used, then the structure is simple and easy to synthesize, but the delivery efficiency into cell nuclei is low

Engineering Contradiction:
Improveease of synthesisVSAvoiddelivery efficiency into nucleus
Core Design Contradiction:
Ease of manufactureVSProductivity

Solution Approach 1:

The patent combines a sense oligonucleotide and an antisense oligonucleotide to form a double-stranded complex. This merging of two separate components creates a structure that leverages cellular machinery for efficient nuclear delivery while maintaining the antisense functionality for gene silencing and exon skipping.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The sense oligonucleotide acts as an intermediary that facilitates nuclear entry. The double-stranded complex is recognized by cellular transport mechanisms that single-stranded oligonucleotides lack, enabling efficient delivery into the nucleus where the antisense strand can then exert its therapeutic effect.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If double-stranded nucleic acid complexes are used, then the delivery efficiency into cell nuclei is improved, but the structural complexity increases

Engineering Contradiction:
Improvedelivery efficiency into nucleusVSAvoidstructural complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The complex is segmented into two functional domains: the sense oligonucleotide that handles delivery and nuclear entry, and the antisense oligonucleotide that performs gene silencing and exon skipping. This segmentation allows each component to be optimized for its specific function while working together as a unified therapeutic agent.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The double-stranded complex serves multiple functions simultaneously: it acts as a delivery vehicle for nuclear entry, protects the antisense strand from degradation, and maintains the capability for specific target recognition and gene silencing. This multi-functionality justifies the increased structural complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Strength

If RNA oligonucleotides are used as ASO, then the binding affinity to target RNA is high, but the stability in vivo is reduced

Engineering Contradiction:
Improvebinding affinityVSAvoidstability in vivo
Core Design Contradiction:
StrengthVSStability of the object's composition

Solution Approach 1:

Instead of using a single RNA strand that would be degraded, the patent creates a DNA-RNA hybrid complex where the DNA sense strand serves as a stable copy or template. This allows the RNA antisense strand to maintain high binding affinity while the DNA component provides enhanced in vivo stability and protection from nucleases.

Inventive Principle:
Principle #26Copying

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 double-stranded nucleic acid complexes demonstrate enhanced delivery and efficacy in suppressing target gene expression and altering RNA processing, offering potential therapeutic benefits for genetic diseases and other conditions by effectively reaching the nucleus and inducing desired exon skipping effects.

Implementation Method 1

an antisense oligonucleotide which has a sequence complementary to a transcription product of a target gene

Methodology Applied
Scientific EffectBase pairing: Chemical Bonding

Implementation Method 2

double-stranded nucleic acid complexes that include an antisense nucleic acid strand capable of inducing splice-switched variants of RNA, allowing for high specificity and efficiency in delivering antisense oligonucleotides into the nucleus

Methodology Applied
Scientific EffectNuclear import:

Implementation Method 3

a partial DNA-RNA hetero-duplex is formed. Since this structure is recognized by RNase H, and the mRNA of the target gene is thereby decomposed

Methodology Applied
Scientific EffectEnzymatic degradation: Enzyme

Data Source

PatentEP3010514B1Double-stranded antisense nucleic acid with EXON-skipping effect
Publication Date: 2021.01.20 NAT UNIV CORP TOKYO MEDICAL & DENTAL UNIV
  • EP3010514B1 patent drawingFigure 1
  • EP3010514B1 patent drawingFigure 2
  • EP3010514B1 patent drawingFigure 3

AI summary

Disclosed are double-stranded antisense nucleic acid complexes that can efficiently alter the processing of RNA in a cell via an antisense effect, and methods for using the same. One method comprises contacting with the cell a double-stranded nucleic acid complex comprising: a first nucleic acid strand annealed to a second nucleic acid strand, wherein: the first nucleic acid strand comprises (i) nucleotides independently selected from natural DNA nucleotides, modified DNA nucleotides, and nucleotide analogs, (ii) no regions that have 4 or more consecutive natural DNA nucleotides, (iii) the total number of natural DNA nucleotides, modified DNA nucleotides, and nucleotide analogs in the first nucleic acid strand is from 8 to 100, and (iv) the first nucleic acid strand is capable of hybridizing to RNA inside of the cell; and the second nucleic acid strand comprises nucleotides independently selected from natural RNA nucleotides, modified RNA nucleotides, and nucleotide analogs.