Lipidic Particles Induce Immune Tolerance

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Solution Overview

Problem

Protein therapeutics often face challenges due to their immunogenicity, leading to antibody formation that can abrogate protein activity and alter pharmacokinetic properties, necessitating methods to reduce immunogenicity and induce immune tolerance, especially for blood coagulation cascade proteins.

Innovation Solution

The use of lipidic compositions or particles comprising phosphatidylserine (PS), phosphatidylinositol (PI), and phosphatidylcholine (PC) or O-phospho-L-serine (OPLS) to incorporate antigens, which are administered subcutaneously, inducing immune tolerance by increasing TGF-β or IL-10 levels and reducing IL-6, IL-17, and co-stimulatory signals like CD40 and CD86.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If protein therapeutics are administered to treat blood coagulation disorders, then therapeutic efficacy is improved, but immunogenicity increases leading to antibody formation that abrogates protein activity

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidimmunogenicity
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

Lipidic particles comprising phosphatidylserine and phosphatidylcholine are used as intermediary carriers to deliver blood coagulation cascade proteins. These lipidic particles mask the immunogenic epitopes of the therapeutic proteins while facilitating their delivery to target sites, thereby reducing antibody formation while maintaining therapeutic efficacy

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies the physical and chemical parameters of protein delivery by incorporating proteins into lipidic particles with specific compositional ratios (phosphatidylserine:phosphatidylcholine). This parameter change alters the immunogenic properties of the proteins without changing their therapeutic function, reducing immunogenicity while preserving efficacy

Inventive Principle:
Principle #35Parameter changes

2Duration of action of moving object

If protein therapeutics are administered repeatedly to maintain therapeutic levels, then therapeutic coverage is improved, but immune tolerance is reduced due to continuous immune system stimulation

Engineering Contradiction:
Improvetherapeutic coverageVSAvoidimmune tolerance
Core Design Contradiction:
Duration of action of moving objectVSReliability

Solution Approach 1:

The lipidic particle formulation is designed to induce immune tolerance in advance before repeated administrations begin. The specific lipid composition pre-conditiones the immune system to accept the therapeutic protein, allowing subsequent repeated administrations to maintain therapeutic levels without triggering immune responses or losing tolerance

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If standard protein formulations are used for blood coagulation therapies, then ease of administration is maintained, but pharmacokinetic properties are altered by antibody formation

Engineering Contradiction:
Improveease of administrationVSAvoidpharmacokinetic properties
Core Design Contradiction:
Ease of operationVSDuration of action of moving object

Solution Approach 1:

Lipidic particles serve as intermediary delivery vehicles that maintain ease of subcutaneous or intravenous administration while protecting the therapeutic protein from immune-mediated clearance. The particles modify pharmacokinetic properties by reducing antibody formation and altering distribution and clearance patterns

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP2451485B1Lipidic compositions for induction of immune tolerance
Publication Date: 2016.03.02 THE RES FOUND OF STATE UNIV OF NEW YORK
  • EP2451485B1 patent drawingFigure 1(A)a~1(A)b
  • EP2451485B1 patent drawingFigure 1(A)c~1(A)d
  • EP2451485B1 patent drawingFigure 1(B)

AI summary

This invention provides a method for inducing immune tolerance toward an antigen comprising the antigen in lipidic particles or lipidic compositions. The lipidic particles are made up of phosphatidylserine and phosphatidylcholine, or phosphatidylinositol and phosphatidylcholine. The lipidic compositions comprise the antigen and O-phospho-L- serine. Administration of these composition results in inducing immune tolerance to the antigen.