Engineered IgG Fc Regions for Extended Serum Half-Life

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Solution Overview

Problem

There is a need for improved therapeutic IgGs that exhibit enhanced pH-dependent binding to FcRn to extend serum half-life and improve pharmacokinetic properties.

Innovation Solution

Engineered immunoglobulins with mutations Q311R, N434W, and M428E in the human wild-type IgG1 Fc region, altering binding to FcRn to extend serum half-life.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If the Fc region of IgG is engineered to enhance FcRn binding, then serum half-life is extended, but the structural complexity of the antibody increases

Engineering Contradiction:
Improveserum half-lifeVSAvoidstructural complexity
Core Design Contradiction:
Duration of action of moving objectVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by modifying specific amino acid residues in the Fc region (Q311R, N434W, M428E) to alter the chemical properties and binding characteristics of the antibody. These point mutations change local charge distribution and hydrophobicity, thereby enhancing FcRn binding affinity and extending serum half-life without requiring large structural modifications

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention applies local quality by making targeted modifications only in the Fc region's neonatal Fc receptor binding site, specifically at positions 311, 428, and 434. This localized engineering approach allows enhancement of FcRn binding while preserving the overall antibody structure and other functional regions, minimizing structural complexity increase

Inventive Principle:
Principle #3Local quality

2Reliability

If multiple amino acid mutations are introduced to alter FcRn binding, then binding affinity is improved, but manufacturing precision requirements increase

Engineering Contradiction:
Improvebinding affinityVSAvoidmanufacturing precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent applies partial action by introducing a specific combination of three mutations (Q311R, N434W, M428E) that collectively achieve the desired binding enhancement. Rather than attempting numerous mutations, this focused approach of three specific changes provides sufficient improvement in FcRn binding while keeping manufacturing complexity manageable through standardized mutagenesis protocols

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentEP3430039B1Engineered immunoglobulins with altered fcrn binding
Publication Date: 2025.10.22 UNIVERSITY OF OSLO
  • EP3430039B1 patent drawingFigure 1
  • EP3430039B1 patent drawingFigure 2
  • EP3430039B1 patent drawingFigure 3

AI summary

The present invention relates to compositions and methods for antibody-mediated therapy. In particular, provided herein are engineered immunoglobulins with altered half-life.