Nanobody Engineering for TNF-alpha Affinity and Stability

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Solution Overview

Problem

Current Nanobodies against TNF-alpha have limitations in terms of affinity, stability, specificity, and immunogenicity, which affect their therapeutic and diagnostic efficacy for diseases mediated by TNF-alpha.

Innovation Solution

Development of improved Nanobodies with enhanced affinity, stability, and specificity, including multispecific formats that bind to specific epitopes on TNF-alpha, such as those comprising amino acid residues Gln at position 88, Lys at position 90, and Glu at position 146, and linked in a manner allowing intramolecular binding to TNF receptor sites, reducing receptor crosslinking and signal transduction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional Nanobodies against TNF-alpha are used, then they can bind to TNF-alpha, but their affinity, stability, and specificity are insufficient for optimal therapeutic efficacy

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidaffinity and stability
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent applies parameter changes by modifying the amino acid sequence of the Nanobody, specifically optimizing framework regions and complementarity determining regions to enhance binding affinity, thermal stability, and specificity for TNF-alpha while maintaining the ability to block receptor crosslinking

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates composite structures by combining multiple functional elements within the Nanobody sequence, including stabilized framework regions and optimized CDRs, to achieve enhanced overall performance in terms of affinity, stability, and therapeutic efficacy

Inventive Principle:
Principle #40Composite materials

2Power

If Nanobodies are designed to bind with high affinity to TNF-alpha, then potency increases, but immunogenicity may increase reducing therapeutic suitability

Engineering Contradiction:
ImprovepotencyVSAvoidimmunogenicity
Core Design Contradiction:
PowerVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by humanizing the Nanobody sequence and optimizing specific amino acid positions to reduce immunogenicity while preserving or enhancing binding potency against TNF-alpha, making the molecule more suitable for therapeutic applications in human patients

Inventive Principle:
Principle #35Parameter changes

3Reliability

If Nanobodies bind to TNF-alpha epitopes, then they can inhibit receptor crosslinking, but their stability and half-life in vivo may be insufficient

Engineering Contradiction:
Improveinhibition efficacyVSAvoidhalf-life in vivo
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent applies parameter changes by engineering the Nanobody sequence to enhance structural stability and resistance to proteolysis, thereby extending the half-life in vivo while maintaining the ability to effectively inhibit TNF receptor crosslinking and signal transduction

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3613767A1Improved nanobodiestm against tumor cecrosis factor-alpha
Publication Date: 2020.02.26 ABLYNX NV
  • EP3613767A1 patent drawingFigure 1~2
  • EP3613767A1 patent drawingFigure 3
  • EP3613767A1 patent drawingFigure 4

AI summary

The present invention relates to improved Nanobodies™ against Tumor Necrosis Factor-alpha (TNF-alpha), as well as to polypeptides comprising or essentially consisting of one or more of such Nanobodies. The invention also relates to nucleic acids encoding such Nanobodies and polypeptides; to methods for preparing such Nanobodies and polypeptides; to host cells expressing or capable of expressing such Nanobodies or polypeptides; to compositions comprising such Nanobodies, polypeptides, nucleic acids or host cells; and to uses of such Nanobodies, such polypeptides, such nucleic acids, such host cells or such compositions, in particular for prophylactic, therapeutic or diagnostic purposes, such as the prophylactic, therapeutic or diagnostic purposes.