Cell-Penetrating Antibody Complexes for Non-Viral Nucleic Acid Delivery

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Solution Overview

Problem

Current nucleic acid delivery technologies, such as viral vectors and synthetic liposomes, face limitations including complexity of production, limited packaging capacity, and unfavorable immunological features, hindering effective in vivo gene therapy applications.

Innovation Solution

Compositions comprising monoclonal antibodies or their cell-penetrating fragments, like 3E10, are used to non-covalently link with nucleic acid cargo, enabling efficient delivery into cells by forming complexes that can be encapsulated in nanoparticles for targeted delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If viral vectors are used for nucleic acid delivery, then delivery efficiency is improved, but production complexity and immunological risks increase

Engineering Contradiction:
Improvedelivery efficiencyVSAvoidproduction complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent uses cell-penetrating antibodies as intermediary carriers to deliver nucleic acids into cells. These antibodies naturally penetrate cell membranes and can be conjugated to nucleic acid cargo, serving as a mediator that avoids the complexity of viral vector production while maintaining delivery efficiency. The antibody-nucleic acid conjugate system provides a non-viral alternative that simplifies production protocols.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies the parameters of the delivery system by using recombinant antibody technology to create cell-penetrating antibodies with specific properties. By changing the antibody isotype, conjugation chemistry, and cargo attachment methods, the system achieves efficient delivery without the immunogenicity and production complexity associated with viral vectors.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If viral vectors are used for nucleic acid delivery, then delivery efficiency is improved, but immunological safety deteriorates

Engineering Contradiction:
Improvedelivery efficiencyVSAvoidimmunological risks
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent employs non-viral antibody-based carriers that are biodegradable and transient, replacing persistent viral vectors. These antibody-nucleic acid conjugates are naturally cleared by the body after delivering their cargo, reducing long-term immunological risks while maintaining effective delivery. The disposable nature of these carriers eliminates concerns about viral integration and persistent immune activation.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent converts the natural immune clearance mechanism, which is typically a hurdle for nucleic acid delivery, into a benefit by using antibodies that are naturally designed to be immunogenic yet controllable. The Fc region of the antibodies can be engineered to modulate immune responses, turning potential harmful immunogenicity into a controllable feature that enhances delivery while minimizing adverse immune reactions.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Productivity

If conventional liposome delivery is used, then nucleic acid delivery is achieved, but cellular uptake efficiency decreases

Engineering Contradiction:
Improvedelivery capabilityVSAvoidcellular uptake efficiency
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The patent creates composite delivery systems by conjugating cell-penetrating antibodies to nucleic acid cargo. This composite structure combines the protective and delivery capabilities of antibodies with the therapeutic function of nucleic acids, achieving superior cellular uptake compared to conventional liposomes. The antibody component provides active targeting and membrane penetration capabilities that enhance cellular internalization.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent segments the delivery function from the therapeutic cargo by using separate antibody components that can be independently optimized for cell penetration. This segmentation allows the antibody to specialize in cellular uptake while the nucleic acid cargo maintains its therapeutic function, resulting in more efficient delivery compared to all-in-one liposome systems.

Inventive Principle:
Principle #1Segmentation

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

Enhances the uptake and accumulation of nucleic acids in cells, offering a non-viral, efficient, and targeted delivery system for therapeutic nucleic acids, including siRNA and mRNA, with potential applications in gene therapy and CAR T cell therapy.

Implementation Method 1

a monoclonal antibody, cell-penetrating fragment thereof; a monovalent, divalent, or multivalent single chain variable fragment (scFv); or a diabody... wherein (a) and (b) are non-covalently linked

Methodology Applied
Scientific EffectNon-covalent binding: Van der Waals Force

Data Source

PatentEP4021496B1Compositions and methods for delivery of nucleic acids to cells
Publication Date: 2025.12.17 YALE UNIVERSITY
  • EP4021496B1 patent drawingFigure 1A~1B
  • EP4021496B1 patent drawingFigure 1C~1D
  • EP4021496B1 patent drawingFigure 2A~2B

AI summary

Compositions and methods of use thereof for delivering nucleic acid cargo into cells are provided. The compositions typically include (a) a 3E10 monoclonal antibody or an antigen binding, cell-penetrating fragment thereof; a monovalent, divalent, or multivalent single chain variable fragment (scFv); or a diabody; or humanized form or variant thereof, and (b) a nucleic acid cargo including, for example, a nucleic acid encoding a polypeptide, a functional nucleic acid, a nucleic acid encoding a functional nucleic acid, or a combination thereof. Elements (a) and (b) are typically non-covalently linked to form a complex.