BCL11A CRISPR RNP Editing with 3xNLS-Cas9 Nuclear Delivery

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Solution Overview

Problem

Existing CRISPR-Cas9 gene editing systems for altering BCL11A expression in hematopoietic stem cells have variable efficiency, specificity, and persistence, leading to potential genotoxicity and deleterious impacts on stem cell function.

Innovation Solution

Development of a CRISPR enzyme fused with multiple nuclear localization signal (NLS) sequences, specifically a c-Myc-like NLS at the amino terminus and SV40 and nucleoplasmin bipartate NLS at the carboxyl terminus, enhancing gene-editing efficacy in hematopoietic cells.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If CRISPR-Cas9 gene editing system is used to alter BCL11A expression in hematopoietic stem cells, then gene editing capability is achieved, but editing efficiency, specificity, and persistence are variable leading to potential genotoxicity and stem cell dysfunction

Engineering Contradiction:
Improvegene editing capabilityVSAvoidgenotoxicity and stem cell dysfunction
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces nuclear localization signals (NLS) as intermediary sequences that mediate the transport of Cas9 enzyme into the nucleus. By adding specific NLS sequences (such as SV40 NLS, nucleoplasmin NLS, or c-Myc NLS) to the Cas9 protein, the system achieves more reliable nuclear entry and subsequent gene editing, while reducing off-target effects and genotoxicity through improved specificity.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If CRISPR-Cas9 system is used for gene editing in hematopoietic stem cells, then gene modification is achieved, but editing efficiency and persistence are variable

Engineering Contradiction:
Improvegene editing efficiencyVSAvoidpersistence of editing
Core Design Contradiction:
ProductivityVSDuration of action of stationary object

Solution Approach 1:

The patent modifies the Cas9 protein by changing parameters such as adding or modifying nuclear localization signals. This parameter change enhances the editing efficiency by improving nuclear entry and maintains persistence by ensuring sustained Cas9 activity in the nucleus, leading to more durable gene editing outcomes in hematopoietic stem cells.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If CRISPR-Cas9 system is used to decrease BCL11A expression, then fetal hemoglobin induction is achieved, but variable efficiency and specificity lead to potential deleterious impacts

Engineering Contradiction:
Improvefetal hemoglobin inductionVSAvoiddeleterious impacts on stem cell function
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses nuclear localization signals as intermediaries to enhance the reliability of BCL11A expression decrease and subsequent fetal hemoglobin induction. The NLS sequences mediate precise nuclear delivery of Cas9, improving specificity and reducing off-target effects that could cause deleterious impacts on stem cell function.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 CRISPR enzyme with multiple NLS sequences demonstrates improved gene-editing capability, reducing BCL11A expression effectively and safely in hematopoietic cells, promoting fetal hemoglobin induction without detectable genotoxicity or stem cell dysfunction.

Implementation Method 1

CRISPR enzymes fused to nuclear localization signal (NLS) sequences, where the number and type of NLS sequences increases its gene-editing efficacy

Methodology Applied
Scientific EffectNuclear localization signal (NLS):

Data Source

PatentEP3788144B1Enhanced BCL11a RNP / crispr delivery & editing using a 3xnls-cas9
Publication Date: 2025.09.24 CHILDRENS MEDICAL CENT CORP
  • EP3788144B1 patent drawingFigure 1A~1D
  • EP3788144B1 patent drawingFigure 1E~1I
  • EP3788144B1 patent drawingFigure 1J~2A

AI summary

Provided herein are synthetic nucleic acids that encode a CRISPR enzyme fused to a series of nuclear localization signal sequences for the use of altering expression of a gene in a cell. Further provided herein are methods for altering gene expression in a cell comprising introducing the synthetic nucleic acids and a guide RNA, or a polypeptide and a guide RNA into a cell. In certain embodiments the cell is a quiescent cell, for example, a hematopoietic stem cell.