Self-Adjuvanting Fusion Polypeptide Vaccine Platform

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Solution Overview

Problem

Existing vaccine platforms face challenges in rapid development, production, and regulatory approval to cover emerging pathogen variants, particularly due to reliance on exogenous adjuvants and complex production processes.

Innovation Solution

A novel protein-based vaccine platform, PCF, utilizing an immunogenic fusion polypeptide combining the non-toxic B subunit of cholera toxin (CTB) and an immunoglobulin Fc region, which acts as a self-adjuvanting molecule, allowing for easy incorporation of any antigen and facilitating mucosal and systemic vaccine delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If RNA-based vaccines are used, then rapid vaccine development and production are achieved, but adaptability to emerging pathogen variants is limited

Engineering Contradiction:
Improvevaccine development speedVSAvoidadaptability to pathogen variants
Core Design Contradiction:
ProductivityVSAdaptability or versatility

Solution Approach 1:

The patent creates a universal protein-based vaccine platform that can accommodate multiple different antigens through standardized fusion polypeptide constructs. The platform uses consistent structural elements (Fc region, adjuvant domains) that can bind to various pathogen antigens, enabling rapid adaptation to new variants without redesigning the entire vaccine system.

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

2Reliability

If viral vectors or adjuvanted proteins are used, then licensed vaccine platforms are available, but complexity of production and need for exogenous adjuvants increases

Engineering Contradiction:
Improvevaccine platform reliabilityVSAvoidproduction complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the antigen, adjuvant, and delivery vehicle into a single fusion polypeptide construct. The Fc region serves both as a delivery mechanism and binds to adjuvant molecules, eliminating the need for separate adjuvant components and simplifying production while maintaining reliability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The fusion polypeptide is self-adjuvanting, meaning the Fc region inherently provides adjuvant activity through its structure and binding properties. This eliminates the need for external adjuvants and reduces production complexity while maintaining immunogenicity.

Inventive Principle:
Principle #25Self-service

3Reliability

If whole-inactivated vaccine approach is used, then robust immune response is achieved, but biosafety requirements and production complexity increase

Engineering Contradiction:
Improveimmune response robustnessVSAvoidproduction complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts only the essential immunogenic components (antigen epitopes) and combines them with Fc region and adjuvant elements, eliminating the need to produce entire inactivated viruses. This reduces biosafety requirements and production complexity while maintaining immune response robustness through targeted antigen presentation.

Inventive Principle:
Principle #2Taking out (Extraction)

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 PCF platform induces a robust mucosal immune response, is suitable for mucosal administration, and eliminates the need for exogenous adjuvants, thereby simplifying production and enhancing immunogenicity and flexibility in responding to emerging pathogens.

Implementation Method 1

immune cells target the antigen, or fragment or variant thereof, through the Ig-Fc, thereby enhancing its uptake

Methodology Applied
Scientific EffectFc-receptor binding: Adsorption

Implementation Method 2

the antigen, or a fragment or variant thereof, is delivered directly to Fc-receptor-bearing antigen-presenting cells (APCs) in the context of a strong AB5 Toxin-mediated mucosal immune response

Methodology Applied
Scientific EffectReceptor binding: Adsorption

Data Source

PatentUS20250127888A1Immunogenic Fusion Peptides Including FC Fragment and a Non Toxic B Subunit of AB5 Toxin
Publication Date: 2025.04.24 GENECELL BIOTECH INC
  • US20250127888A1 patent drawing
  • US20250127888A1 patent drawing
  • US20250127888A1 patent drawing

AI summary

The invention relates to fusion polypeptides, and to immunogenic polypeptides and their use as vaccines for treating, preventing or ameliorating a wide range of infectious diseases, for example caused by a virus, bacterium or fungus, or cancer. The fusion polypeptide comprises: a first amino acid sequence comprising a non-toxic B subunit of an AB5 Toxin, or a fragment or variant thereof; a second amino acid sequence comprising an immunoglobulin Fc region (Ig-Fc), or a fragment or variant thereof; and a third amino acid sequence comprising an antigen, or a fragment or variant thereof. The invention also extends to nucleic acids encoding such fusion polypeptides and proteins, and to recombinant vectors expressing such nucleic acids. The invention is especially useful for the rapid development of protein-based vaccines, and to their use in methods of treating infectious diseases or cancer, and also to pharmaceutical compositions comprising the fusion proteins.