B7H3 Antibody-Drug Conjugate Linker Design for Plasma Stability

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Solution Overview

Problem

Current therapeutic molecules against B7H3, a protein overexpressed in various human malignancies, are limited in effectiveness and there is a clinical need for novel anti-B7H3 antibodies or antibody-drug conjugates.

Innovation Solution

Development of an antibody-drug conjugate specifically targeting B7H3, comprising a B7H3-targeting antibody or its antigen-binding fragment, a linker unit, and a cytotoxic drug, with specific amino acid sequences for the heavy and light chain variable regions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional therapeutic molecules against B7H3 are used, then treatment is provided, but effectiveness is limited

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidclinical applicability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent modifies the antibody structure by changing amino acid sequences in the variable regions (HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, LCDR3) to improve binding affinity to B7H3. The antibody-drug conjugate system changes the therapeutic parameter from conventional molecules to targeted ADC delivery, enhancing effectiveness against B7H3-expressing tumors while maintaining clinical applicability through specific antigen targeting.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If antibody-drug conjugate is designed with specific amino acid sequences, then affinity for human B7H3 is improved, but manufacturing complexity increases

Engineering Contradiction:
Improvebinding affinityVSAvoidproduction feasibility
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent specifies precise amino acid sequences for HCDR1 (SEQ ID NO: 1), HCDR2 (SEQ ID NO: 2), HCDR3 (SEQ ID NO: 3), LCDR1 (SEQ ID NO: 4 or 7), LCDR2 (SEQ ID NO: 5), and LCDR3 (SEQ ID NO: 6) to optimize B7H3 binding affinity. These sequence parameters are engineered through molecular biology techniques, allowing controlled production of the antibody component while maintaining high affinity through rational design rather than random screening.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If cytotoxic drug is conjugated to antibody, then anti-tumor effect is enhanced, but plasma stability may be compromised

Engineering Contradiction:
Improveanti-tumor efficacyVSAvoidplasma stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent introduces a linker unit as an intermediary component between the antibody and cytotoxic drug. This linker serves as a mediator that maintains the stability of the antibody-drug conjugate in plasma by preventing premature drug release, while still enabling targeted delivery to B7H3-expressing tumor cells and subsequent cytotoxic effect upon internalization or activation at the target site.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP4537853A1Anti-b7h3 antibody-drug conjugate and use thereof
Publication Date: 2025.04.16 DUALITY BIOLOGICS (SUZHOU) CO LTD
  • EP4537853A1 patent drawingFigure 1~2
  • EP4537853A1 patent drawingFigure 3~5
  • EP4537853A1 patent drawingFigure 6~7

AI summary

The present invention provides an antibody-drug conjugate specifically binding to B7H3 and a pharmaceutical composition comprising the same. A method for using the antibody-drug conjugate of the present invention and use thereof are also provided herein.