Cycloalkane Ionizable Lipid for pH-Responsive Nucleic Acid Delivery

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Solution Overview

Problem

Existing non-viral carriers for nucleic acid delivery, such as cationic liposomes and polymers, exhibit high cytotoxicity and low transfection efficiency, limiting their effectiveness in delivering nucleic acids to target sites within cells and animals.

Innovation Solution

A cycloalkane-based lipid compound is synthesized as a component of lipid nanoparticles, comprising a central cycloalkane structure with specific substituents and terminal groups, which can change charge state based on pH, enhancing nucleic acid delivery efficiency by facilitating escape from endosomes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If non-viral carriers such as cationic liposomes and polymers are used for nucleic acid delivery, then delivery capability is achieved, but cytotoxicity increases and transfection efficiency decreases

Engineering Contradiction:
Improvenucleic acid delivery capabilityVSAvoidcytotoxicity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent modifies the chemical structure of ionizable lipids by introducing cycloalkane groups at specific positions (R1-R6) with varying chain lengths and configurations. This structural parameter change optimizes the balance between delivery capability and cytotoxicity reduction, as evidenced by the systematic variation of substituents in formulas 1-4 and their corresponding biological activity results

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention creates composite lipid structures combining cycloalkane hydrophobic cores with ionizable amino groups and lipid tails. This composite approach integrates the advantages of different molecular components: the cycloalkane provides structural stability and reduced cytotoxicity, while the ionizable groups enable pH-responsive endosomal escape and nucleic acid complexation

Inventive Principle:
Principle #40Composite materials

2Reliability

If non-viral carriers such as cationic liposomes and polymers are used for nucleic acid delivery, then delivery capability is achieved, but transfection efficiency decreases

Engineering Contradiction:
Improvenucleic acid delivery capabilityVSAvoidtransfection efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent optimizes transfection efficiency by systematically varying parameters including cycloalkane ring size, substituent position (R1-R6), chain length (n1, n2), and terminal group configurations. These parameter changes enhance the lipid's ability to facilitate endosomal escape and nuclear delivery, as demonstrated by the structure-activity relationship data across multiple compound examples

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The cycloalkane-based ionizable lipid acts as an intermediary that mediates the interaction between nucleic acids and cellular components. It forms temporary complexes with nucleic acids for protection and delivery, then facilitates release into the cytoplasm and nucleus through pH-dependent conformational changes, thereby improving transfection efficiency

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 cycloalkane-based lipid compound improves nucleic acid delivery efficiency, increasing the effectiveness of nucleic acid-based therapeutic agents by enhancing cellular uptake and reducing cytotoxicity.

Implementation Method 1

comprising a central cycloalkane structure with specific substituents and terminal groups, which can change charge state based on pH, enhancing nucleic acid delivery efficiency by facilitating escape from endosomes

Methodology Applied
Scientific EffectpH-dependent charge state change: Phase Change

Data Source

PatentEP4640669A1Cycloalkane-based lipid compound for delivering nucleic acids, and lipid nanoparticles comprising same
Publication Date: 2025.10.29 GC BIOPHARMA CORP
  • EP4640669A1 patent drawingFigure 1~2
  • EP4640669A1 patent drawingFigure 3~4
  • EP4640669A1 patent drawingFigure 5~6

AI summary

The present invention provides a cycloalkane-based lipid compound of Formula 1 and a pharmaceutically acceptable salt thereof. The cycloalkane-based lipid compound is a compound having a form in which carbonyl-based substituents are bonded to the central structure of a cycloalkane. The cycloalkane-based lipid compound according to the present invention is used as an ionizable lipid, which is a component of a lipid nanoparticle for delivering a nucleic acid.