Monoclonal BKV Antibodies for Broad Neutralization in Transplant Care

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Solution Overview

Problem

Current treatments for BKV and JCV infections in immunocompromised individuals are not specific, effective, or safe, and existing therapies like IVIG have batch-to-batch variations and risks of hemolysis.

Innovation Solution

Development of human monoclonal antibodies with specific amino acid sequences that bind and neutralize multiple BKV subtypes, including I, II, and IV, and JCV, with desirable pharmacokinetic properties and reduced auto-reactivity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If human monoclonal antibodies are developed with specific amino acid sequences, then binding affinity and neutralization capability are improved, but development complexity and manufacturing cost increase

Engineering Contradiction:
Improveneutralization capabilityVSAvoiddevelopment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent develops human monoclonal antibodies with specific amino acid sequences that can neutralize multiple BKV subtypes (I, II, and IV) and JCV simultaneously. This multi-functional antibody design resolves the contradiction by achieving broad-spectrum neutralization capability through engineered specificity, where the complex development effort yields a single therapeutic agent that replaces multiple potential treatments.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The invention utilizes precise amino acid sequence modifications in the variable domains of the monoclonal antibodies to optimize binding affinity and neutralization efficacy. By changing specific molecular parameters (amino acid sequences), the patent achieves enhanced reliability in neutralization while managing development complexity through targeted molecular engineering rather than trial-and-error approaches.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If IVIG preparations are used for treatment, then broad viral coverage is achieved, but batch-to-batch variations and hemolysis risk occur

Engineering Contradiction:
Improveviral coverageVSAvoidsafety and consistency
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent extracts and isolates specific neutralizing antibodies from complex IVIG preparations to create purified monoclonal antibody therapies. By taking out the effective neutralizing components while removing the problematic mixture of uncharacterized IgGs, the invention achieves both broad viral coverage and consistent safety profiles, eliminating batch-to-batch variations and hemolysis risks associated with commercial IVIG products.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention creates standardized copies of specific neutralizing antibody sequences that can be reproduced consistently. Rather than relying on variable natural antibodies from different plasma donors, the patent establishes defined amino acid sequences that can be manufactured with high fidelity, ensuring reliable and consistent therapeutic effect across all batches while maintaining broad viral coverage.

Inventive Principle:
Principle #26Copying

3Reliability

If pre-emptive immunosuppression reduction is implemented, then BKV replication is reduced, but graft rejection risk increases

Engineering Contradiction:
ImproveBKV replication controlVSAvoidgraft rejection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces human monoclonal antibodies as intermediary agents that specifically target and neutralize BKV and JCV without affecting the overall immunosuppression regimen. These antibodies act as mediators that provide antiviral protection while allowing maintenance of necessary immunosuppressive therapy to prevent graft rejection, thereby resolving the contradiction between viral control and graft acceptance.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention converts the presence of immunocompromised state, which is harmful for viral control, into a manageable condition by providing targeted antiviral therapy. The monoclonal antibodies transform the vulnerable immunocompromised state into an opportunity for precise, targeted intervention that protects against viral replication while preserving the immunosuppression needed for graft acceptance, effectively converting harm into benefit.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

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 antibodies provide a targeted therapeutic approach with high affinity and broad neutralization capabilities, reducing the risk of graft rejection and severe complications in transplant recipients.

Implementation Method 1

human monoclonal antibodies, or antigen-binding fragment thereof, directed against a polyomavirus, in particular BKV... that binds and neutralizes a plurality of BK virus subtypes... high affinity and broad neutralization capabilities

Methodology Applied
Scientific EffectAntigen-antibody binding:

Data Source

PatentUS20250376504A1BK virus neutralizing antibodies
Publication Date: 2025.12.11 UNIVERSITY OF STRASBOURG
  • US20250376504A1 patent drawing
  • US20250376504A1 patent drawing
  • US20250376504A1 patent drawing

AI summary

The present patent application relates to the fields of antibodies and polyomaviruses. More specifically, the present patent application relates to a human monoclonal antibody, or antigen-binding fragment thereof, directed against a polyomavirus, in particular BKV, and that is useful in the treatment of an infection by said polyomavirus or associated-disorder thereof.