3'-UTR Sequence Selection for mRNA Stability Without Recombination

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Solution Overview

Problem

Current RNA-based cancer vaccines face challenges in achieving high stability and translation efficiency due to the short half-life of RNA and difficulties in cloning and transcription processes, particularly with sequences like the human beta-globin 3'-UTR, which can lead to recombination and mispriming issues during PCR amplification.

Innovation Solution

Incorporating specific sequences from the 3'-untranslated regions of FCGRT, LSP1, CCL22, AES, PLD3, MT-RNR1, and HLA-DRB4 into RNA expression vectors, along with a polyadenyl sequence with an open end, to enhance stability and translation efficiency, and using type IIS restriction cleavage sites for linearization to prevent masking of the poly(A) sequence.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If two consecutive copies of the human beta-globin 3'-UTR sequence are used in the plasmid DNA, then RNA stability and translational efficiency are improved, but recombination occurs during propagation in E. coli and mispriming occurs during PCR amplification

Engineering Contradiction:
ImproveRNA stabilityVSAvoidcloning difficulty
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent divides the stabilizing function into separate modular elements: a 3'-UTR sequence from one gene and a poly(A) sequence from another gene. These can be independently selected and combined, allowing optimization of each element without the recombination problems of duplicated sequences. The segmentation allows each functional element to be manufactured and verified separately before assembly.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a linker sequence as an intermediary element between the 3'-UTR and poly(A) sequence. This linker serves as a buffer zone that prevents unwanted interactions between the two functional elements while maintaining their individual stabilizing effects. The linker acts as a mediator that allows the combination of beneficial elements without causing the recombination issues seen with adjacent identical sequences.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If the polyadenyl cassette is positioned downstream of the poly(A) sequence, then the poly(A) sequence is not masked, but the cleavage site may still interfere with transcript stability

Engineering Contradiction:
Improvepoly(A) sequence accessibilityVSAvoidtranscript stability
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The patent extracts the poly(A) sequence from its traditional position within the polyadenyl cassette and places it upstream, followed by the cleavage site and then the 3'-UTR sequence. This repositioning takes out the poly(A) sequence from potential masking by downstream elements while maintaining its functional integrity. The cleavage site is positioned downstream to perform its function without interfering with the poly(A) sequence accessibility.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the spatial arrangement of elements along the transcript by positioning the poly(A) sequence upstream rather than downstream of the cleavage site. This dimensional reorganization allows the poly(A) sequence to be accessible while the cleavage site remains functional, resolving the conflict between accessibility and stability by changing the linear order of elements.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Manufacturing precision

If type IIS restriction cleavage sites are used for linearization, then the poly(A) sequence is not masked, but the cleavage site remains in the transcript which may affect stability

Engineering Contradiction:
Improvepoly(A) sequence accessibilityVSAvoidtranscript stability
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The patent creates a functional copy of the poly(A) sequence upstream of the cleavage site, while the downstream polyadenyl cassette serves as a template for proper polyadenylation. This copying approach ensures that the poly(A) sequence is accessible and functional even after cleavage, while the original cassette position allows proper processing. The cleavage site can be removed in subsequent steps if desired, but the upstream copy ensures functionality.

Inventive Principle:
Principle #26Copying

Data Source

PatentEP3636764B13' UTR sequences for stabilization of RNA
Publication Date: 2021.03.03 BIONTECH SE
  • EP3636764B1 patent drawingFigure 1A
  • EP3636764B1 patent drawingFigure 1B
  • EP3636764B1 patent drawingFigure 2A

AI summary

The present invention relates to stabilization of RNA, in particular mRNA, and an increase in mRNA translation. The present invention particularly relates to a modification of RNA, in particular in vitro-transcribed RNA, resulting in increased transcript stability and/or translation efficiency. According to the invention, it was demonstrated that certain sequences in the 3'-untranslated region (UTR) of an RNA molecule improve stability and translation efficiency.