Modified RNA Nucleosides for Low-Immunogenic Protein Expression

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Solution Overview

Problem

Existing in vitro-synthesized RNA molecules, such as mRNA, oligoribonucleotides, and polyribonucleotides, exhibit high immunogenicity, leading to significant cytokine secretion when interacting with dendritic cells, which can trigger immune responses.

Innovation Solution

Incorporation of pseudouridine (Ψ) or 1-methylpseudouridine (m1Ψ) into the RNA molecules, along with a poly-A tail, m7GppG cap, and cap-independent translational enhancers, reduces immunogenicity by measuring decreased cytokine secretion in murine or human dendritic cells.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If in vitro-synthesized RNA molecules are used, then protein expression can be achieved, but immunogenicity increases leading to cytokine secretion

Engineering Contradiction:
Improveprotein expressionVSAvoidimmunogenicity
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by incorporating modified nucleosides (pseudouridine Ψ, 1-methylpseudouridine m1Ψ, 5-methylcytidine m5C) into the RNA molecules. These chemical modifications change the nucleoside parameters of the RNA, reducing its immunogenicity while maintaining protein expression capability. The modified RNA molecules show decreased cytokine secretion in dendritic cells compared to unmodified RNA.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If unmodified in vitro-synthesized RNA is used, then translation can occur, but immune response is triggered

Engineering Contradiction:
Improvetranslation efficiencyVSAvoidcytokine secretion
Core Design Contradiction:
ProductivityVSObject-generated harmful factors

Solution Approach 1:

The patent modifies the RNA molecules by incorporating pseudouridine (Ψ), 1-methylpseudouridine (m1Ψ), and/or 5-methylcytidine (m5C) at specific positions within the RNA sequence. These parameter changes in the nucleoside structure reduce the RNA's ability to trigger cytokine secretion in dendritic cells while preserving its translation efficiency for protein expression.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP4332227B1RNA containing modified nucleosides and methods of use thereof
Publication Date: 2026.02.11 THE TRUSTEES OF THE UNIV OF PENNSYLVANIA
  • EP4332227B1 patent drawingFigure 1
  • EP4332227B1 patent drawingFigure 2A~2C
  • EP4332227B1 patent drawingFigure 3A~3D

AI summary

This invention provides RNA, oligoribonucleotide, and polyribonucleotide molecules comprising pseudouridine or a modified nucleoside, gene therapy vectors comprising same, methods of synthesizing same, and methods for gene replacement, gene therapy, gene transcription silencing, and the delivery of therapeutic proteins to tissue in vivo, comprising the molecules. The present invention also provides methods of reducing the immunogenicity of RNA, oligoribonucleotide, and polyribonucleotide molecules.