Antisense Oligonucleotides for Stable MicroRNA Silencing

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Solution Overview

Problem

Current oligonucleotide approaches for inhibiting microRNAs, such as those using LNA-modified oligonucleotides, face challenges including low in vivo stability, inefficient uptake, and high dosages required for effective silencing, which limits their therapeutic potential for diseases associated with microRNA dysregulation.

Innovation Solution

Designing short oligonucleotides with high affinity nucleotide analogues like LNA, 2'-MOE RNA, or 2'-Fluoro nucleotides, specifically targeting the seed sequence of microRNAs to form stable and non-functional duplexes, thereby reducing microRNA repression without significant off-target effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If LNA-modified oligonucleotides are used to inhibit microRNAs, then silencing efficacy is improved, but in vivo stability deteriorates

Engineering Contradiction:
Improvesilencing efficacyVSAvoidin vivo stability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent modifies the chemical parameters of the oligonucleotide by incorporating specific nucleotide analogues (2'-O-methyl RNA, 2'-fluoro DNA) in defined patterns within the LNA-modified sequence. This changes the binding affinity and stability parameters to achieve optimal silencing efficacy while improving in vivo stability compared to fully LNA-modified oligonucleotides.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The oligonucleotide employs a composite structure combining different nucleotide types (DNA, RNA, LNA, 2'-O-methyl RNA, 2'-fluoro DNA) in a single sequence. This composite approach allows each component to contribute specific properties: LNA provides high affinity binding, while 2'-O-methyl and 2'-fluoro modifications enhance stability and reduce immunogenicity, resolving the contradiction between efficacy and stability.

Inventive Principle:
Principle #40Composite materials

2Productivity

If high dosages of oligonucleotides are administered, then silencing efficacy is improved, but toxicity increases

Engineering Contradiction:
Improvesilencing efficacyVSAvoidtoxicity
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent optimizes the dosage parameter by demonstrating that the modified oligonucleotide sequence achieves effective silencing at lower concentrations (e.g., 1-10 mg/kg) compared to conventional oligonucleotides. The enhanced binding affinity per molecule allows reduced dosing, thereby improving the efficacy-toxicity ratio.

Inventive Principle:
Principle #35Parameter changes

3Duration of action of stationary object

If short oligonucleotides with high affinity nucleotide analogues are designed, then silencing duration is improved, but manufacturing complexity increases

Engineering Contradiction:
Improvesilencing durationVSAvoidmanufacturing complexity
Core Design Contradiction:
Duration of action of stationary objectVSEase of manufacture

Solution Approach 1:

The patent extends the duration of action by designing oligonucleotides with increased binding affinity through strategic LNA and 2'-fluoro modifications. The shorter sequence (15-25 nucleotides) with high-affinity modifications provides prolonged silencing duration while simplifying the overall molecular structure compared to longer conventional oligonucleotides, thereby managing manufacturing complexity.

Inventive Principle:
Principle #35Parameter changes

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 proposed solution achieves efficient and long-lasting silencing of microRNAs with reduced dosages, enhancing therapeutic efficacy while minimizing toxicity and off-target effects, as demonstrated by the oligonucleotide sequence 5'-CcAttGTcaCaCtCC, which forms a stable duplex with microRNA targets, effectively reducing their functional levels in vivo.

Implementation Method 1

MicroRNAs (miRNAs) are an abundant class of short endogenous RNAs that act as post-transcriptional regulators of gene expression by base-pairing with their target mRNAs

Methodology Applied
Scientific EffectBase-pairing: Chemical Bonding

Data Source

PatentEP2261333B1Pharmaceutical composition comprising anti-miRNA antisense oligonucleotides
Publication Date: 2016.03.30 ROCHE INNOVATION CENT COPENHAGEN AS
  • EP2261333B1 patent drawingFigure 1
  • EP2261333B1 patent drawingFigure 2a~2b
  • EP2261333B1 patent drawingFigure 3A~3B

AI summary

The invention provides pharmaceutical compositions comprising short single stranded oligonucleotides, of length of between 8 and 26 nucleobases which are complementary to human microRNAs selected from the group consisting of miR19b, miR21, miR122a, miR155 and miR375. The short oligonucleotides are particularly effective at alleviating miRNA repression in vivo. It is found that the incorporation of high affinity nucleotide analogues into the oligonucleotides results in highly effective anti-microRNA molecules which appear to function via the formation of almost irreversible duplexes with the miRNA target, rather than RNA cleavage based mechanisms, such as mechanisms associated with RNaseH or RISC.