Segmented Poly(A) Tail Coding Sequence for Stable mRNA Templates

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Solution Overview

Problem

The existing methods for synthesizing mRNA drugs in vitro are unstable due to the shortening of poly (A) tail transcription template DNA in vitro, leading to reduced in vivo stability and biological activity of mRNA.

Innovation Solution

An engineered DNA molecule with a specific poly (A) tail coding sequence, comprising elements a, b, c, and d, designed to enhance stability during replication and transcription, ensuring a defined sequence for poly (A) tail stability and regulatory control.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If poly (dA:dT) repeat sequence is used in template plasmid for co-transcriptional addition of poly (A) tail, then poly (A) tail can be added to mRNA, but the sequence is unstable during replication in E. coli with deletion mutations occurring

Engineering Contradiction:
Improvestability of poly (A) tailVSAvoidstability of poly (dA:dT) repeat sequence
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The poly (A) tail coding sequence is divided into multiple segments (element a with ≥20 consecutive A nucleotides, element b with 3-19 consecutive A nucleotides, element c with non-A nucleotides, and element d with 2-20 nucleotides where terminal nucleotides are not A). These segmented elements are arranged in specific patterns to prevent deletion mutations while ensuring stable poly (A) tail production during E. coli replication.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different regions of the poly (A) tail coding sequence have different nucleotide compositions and lengths optimized for specific functions. Element a provides the core poly (A) sequence, while elements b, c, and d provide local variations that prevent instability. The non-A nucleotides in element c and the specific terminal nucleotides in element d create local sequence diversity that prevents deletion mutations.

Inventive Principle:
Principle #3Local quality

2Productivity

If poly (dA:dT) repeat sequence is used for poly (A) tail addition, then mRNA can be produced, but deletion mutations lead to shortening of poly (dA:dT) affecting in vivo stability and biological activity

Engineering Contradiction:
ImprovemRNA productionVSAvoidpoly (A) tail length consistency
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The poly (A) tail coding sequence is pre-designed with a specific structure comprising element a (≥20 consecutive A nucleotides), element b (3-19 consecutive A nucleotides), element c (non-A nucleotides), and element d (2-20 nucleotides with non-A terminal nucleotides). This preliminary structural design prevents deletion mutations during plasmid replication, ensuring that the poly (A) tail length remains consistent throughout the mRNA production process.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention changes the parameters of the poly (A) tail coding sequence by specifying exact length ranges for different elements (element a: ≥20 nt, element b: 3-19 nt, element c: 2-20 nt, element d: 2-20 nt) and nucleotide compositions. These parameter specifications ensure that the poly (A) tail maintains a defined length and sequence, preventing shortening due to deletion mutations during large-scale fermentation.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If conventional poly (A) tail coding sequence is used, then in vitro transcription can proceed, but the sequence is prone to deletion mutations during large scale fermentation

Engineering Contradiction:
Improvein vitro transcription capabilityVSAvoidreplication stability in E. coli
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The poly (A) tail coding sequence is segmented into distinct functional elements (element a, b, c, d) with specific nucleotide compositions and length ranges. This segmentation prevents deletion mutations during E. coli replication while maintaining the sequence's capability to direct poly (A) tail addition during in vitro transcription. The segmented structure allows the sequence to be reliably propagated in large-scale fermentation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The poly (A) tail coding sequence is constructed as a composite of different nucleotide elements with specific properties. Element a provides the core poly (A) sequence, element b provides additional A nucleotides with controlled length, element c provides non-A nucleotide interruptions, and element d provides terminal sequences with specific constraints. This composite structure enhances replication stability in E. coli while maintaining in vitro transcription capability.

Inventive Principle:
Principle #40Composite materials

Data Source

PatentEP4674967A1Engineered DNA molecule for coding RNA
Publication Date: 2026.01.07 RINUAGENE BIOTECHNOLOGY CO LTD
  • EP4674967A1 patent drawingFigure 1~2
  • EP4674967A1 patent drawingFigure 3~5
  • EP4674967A1 patent drawingFigure 6~7

AI summary

An engineered DNA molecule capable of being replicated in a cell, comprising a poly (A) tail coding sequence that makes the engineered DNA molecule more conservative when replicated in cells, particularly in prokaryotic cells, while adjusting the expression level of RNA in eukaryotic cells. Also provided are an RNA comprising the poly (A) tail and a use thereof.