Antisense Oligonucleotides for CEP290 Splicing Correction

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Solution Overview

Problem

Current gene augmentation therapies, such as those using adeno-associated vectors, are limited in treating Leber congenital amaurosis caused by CEP290 mutations due to cargo size constraints and difficulty in controlling expression levels, especially for genes like CEP290 with larger cDNAs, and existing therapies struggle to effectively address the aberrant splicing caused by intronic mutations.

Innovation Solution

Development of viral vectors expressing exon skipping antisense oligonucleotides that specifically target and exclude the aberrant exon from CEP290 mRNA, using sequences complementary to identified nucleotide sequences, to restore normal splicing and protein production, delivered via AAV vectors to modulate splicing and treat CEP290-related diseases.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If gene augmentation therapy using AAV vectors is used to treat LCA, then therapeutic effect is improved for small genes like RPE65, but treatment becomes ineffective for larger genes like CEP290 due to cargo size constraints

Engineering Contradiction:
Improvetherapeutic effectVSAvoidcargo size
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The invention extracts and removes the problematic intron 26 containing the cryptic splice donor site from the CEP290 pre-mRNA through antisense oligonucleotide-mediated exon skipping. This allows the therapeutic approach to bypass the need to deliver the entire large CEP290 gene, instead targeting only the specific defective region, thereby resolving the cargo size limitation of AAV vectors.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces antisense oligonucleotides as intermediary molecules that bind to the cryptic splice donor site in intron 26, preventing aberrant splicing. These oligonucleotides serve as mediators between the AAV vector delivery system and the CEP290 gene, enabling targeted correction of splicing defects without requiring delivery of the entire large gene sequence.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If gene replacement therapy is used to treat LCA, then functional protein production is improved, but control over expression levels becomes difficult

Engineering Contradiction:
Improvefunctional protein productionVSAvoidexpression level control
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

Instead of replacing the entire CEP290 gene, the invention applies partial action by targeting only the specific cryptic splice donor site in intron 26 with antisense oligonucleotides. This partial targeting approach restores normal splicing of the endogenous gene while maintaining its native regulation mechanisms, thereby achieving functional protein production with preserved expression control.

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The invention enables the endogenous CEP290 gene to serve itself by using its own regulatory elements and splicing machinery. The antisense oligonucleotides temporarily correct the splicing defect, allowing the gene to resume its normal self-regulated expression without requiring external control mechanisms from a replacement gene.

Inventive Principle:
Principle #25Self-service

3Ease of operation

If traditional therapy approaches are used for LCA, then treatment simplicity is maintained, but ability to address aberrant splicing caused by intronic mutations is insufficient

Engineering Contradiction:
Improvetreatment simplicityVSAvoidsplicing correction efficacy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The invention replaces traditional mechanical gene delivery approaches with a molecular biology-based approach using antisense oligonucleotides. These oligonucleotides specifically bind to and block the cryptic splice donor site through base pairing, providing precise molecular-level correction of splicing defects while maintaining relative treatment simplicity through AAV-mediated delivery.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 approach effectively redirects normal splicing of CEP290 mRNA, increasing wild-type protein synthesis, potentially delaying or preventing the progression of Leber congenital amaurosis by specifically targeting and correcting aberrant splicing defects, offering a therapeutic strategy for CEP290-associated conditions.

Implementation Method 1

antisense oligonucleotide that binds to and/or is complementary to a polynucleotide with the nucleotide sequence as shown in SEQ ID NO: 17

Methodology Applied
Scientific EffectNucleic acid hybridization: Absorption (physical)

Data Source

PatentEP3189142B1Antisense oligonucleotides for the treatment of leber congenital amaurosis
Publication Date: 2020.07.15 STICHTING KATHOLIEKE UNIV
  • EP3189142B1 patent drawingFigure 1A~1C
  • EP3189142B1 patent drawingFigure 2a
  • EP3189142B1 patent drawingFigure 2b

AI summary

The present invention relates to the fields of medicine and immunology. In particular, it relates to novel antisense oligonucleotides that may be used in the treatment, prevention and/or delay of Leber congenital amaurosis.