Directed-Evolution rAAV Capsids for Brain and Heart Enrichment

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Solution Overview

Problem

Existing recombinant adeno-associated viruses (rAAVs) do not efficiently target and transduce brain and heart tissues upon systemic delivery, limiting their effectiveness in treating related diseases.

Innovation Solution

Engineering rAAVs with peptide insertions and substitutions in the capsid structure through directed evolution in non-human primates, resulting in variants with enhanced transduction enrichment in brain and heart tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If unmodified rAAVs such as AAV9 are used for systemic delivery, then the virus can be easily administered, but the tissue enrichment in brain and heart is insufficient

Engineering Contradiction:
Improvesystemic deliveryVSAvoidtissue enrichment
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies parameter changes by modifying the capsid protein sequence of AAV9 through directed evolution in non-human primates. Specific amino acid residues were mutated to alter capsid properties, enabling the virus to achieve both easy systemic delivery and enhanced tissue enrichment in brain and heart, resolving the contradiction between administration ease and targeting reliability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs feedback mechanisms through iterative selection rounds in non-human primates. The capsid variants were continuously selected and refined based on observed transduction efficiency and tissue enrichment data, allowing the system to learn from previous generations and progressively improve both deliverability and targeting accuracy

Inventive Principle:
Principle #23Feedback

2Reliability

If existing AAV serotypes are used, then the vector has low immunogenicity and long-term persistence, but the transduction efficiency in brain and heart is limited

Engineering Contradiction:
Improvepersistence and low immunogenicityVSAvoidtransduction efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent applies local quality by making targeted modifications to specific regions of the capsid protein while maintaining the overall structure and properties that confer low immunogenicity and long-term persistence. The mutations were localized to specific amino acid positions that influence transduction efficiency without compromising the fundamental safety characteristics of the AAV vector

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent utilizes parameter changes by carefully adjusting capsid protein parameters (amino acid sequences) to enhance transduction efficiency in brain and heart while preserving the inherent safety profile of AAV. The directed evolution process optimized productivity parameters without sacrificing the reliability attributes of persistence and low immunogenicity

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20250255989A1Adeno-associated virus compositions having increased brain enrichment and/or heart enrichment
Publication Date: 2025.08.14 CAPSIDA BIOTHERAPEUTICS INC

AI summary

Described herein are compositions and kits comprising recombinant adeno-associated viruses (rAAVs) with increased transduction enrichment in the brain, heart, or brain and heart. The rAAV compositions described herein encapsidate a transgene, such as a therapeutic nucleic acid. Gene therapy using the rAAVs is described. Also described are methods of treating brain-related and heart-related diseases and conditions.