RSV F Protein Mutants for Pre-Fusion Conformation Stability

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Solution Overview

Problem

Current RSV vaccines fail to elicit sufficient levels of protection due to the challenge of maintaining the pre-fusion conformation of the RSV F protein, which is crucial for neutralizing antibodies to bind effectively, as the protein often converts to the less effective post-fusion form under stress conditions.

Innovation Solution

Development of RSV F protein mutants with engineered disulfide bonds, cavity-filling mutations, and electrostatic mutations to stabilize the pre-fusion conformation, enhancing immunogenicity and stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the RSV F protein is used as a vaccine antigen, then neutralizing antibody responses can be elicited, but the protein converts to the post-fusion form under stress conditions, reducing vaccine efficacy

Engineering Contradiction:
Improvevaccine efficacyVSAvoidpre-fusion conformation stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies parameter changes by introducing specific amino acid substitutions at defined positions in the F protein sequence. These substitutions alter the physical-chemical parameters of the protein structure, specifically enhancing the stability of the pre-fusion conformation through engineered disulfide bonds and cavity-filling mutations that prevent thermal denaturation and conformational conversion to the post-fusion state

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite structure by combining the native F protein sequence with engineered stabilizing elements, including disulfide bonds and hydrophobic cavity fillers. This composite approach integrates foreign amino acid residues into the native protein framework to create a hybrid structure that maintains immunogenicity while gaining enhanced thermal and conformational stability

Inventive Principle:
Principle #40Composite materials

2Stability of the object's composition

If mutations are introduced to stabilize the pre-fusion conformation, then protein stability improves, but the complexity of protein engineering increases

Engineering Contradiction:
Improvepre-fusion conformation stabilityVSAvoidprotein engineering complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent applies local quality by introducing stabilizing mutations only at specific, strategically chosen positions within the F protein sequence rather than throughout the entire structure. The mutations are localized to regions that provide maximum stabilizing effect with minimal disruption to overall protein function and immunogenicity, such as creating disulfide bonds at defined cysteine positions and filling specific hydrophobic cavities

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP3393512B1RSV f protein mutants
Publication Date: 2025.11.19 PFIZER INC
  • EP3393512B1 patent drawingFigure 1
  • EP3393512B1 patent drawingFigure 2A
  • EP3393512B1 patent drawingFigure 2B

AI summary

The present disclosure relates to RSV F protein mutants, nucleic acids or vectors encoding a RSV F protein mutant, compositions comprising a RSV F protein mutant or nucleic acid, and uses of the RSV F protein mutants, nucleic acids or vectors, and compositions.