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November 26, 2025Cell Reports MedicineOpen Access

Engineered AAV capsids fully evade neutralization and increase therapeutic GAA upon redosing in Pompe disease models.

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Why the study?

Pre-existing immunity, high seroprevalence, and broad antigenic cross-reactivity of primate-derived AAVs limit patient eligibility and preclude therapeutic redosing in gene therapy.

Does AAV.div3A enable gene therapy redosing by evading neutralizing antibodies in preclinical models?

Population

Mice, including a Pompe disease model

Comparison

AAV.div3A or AAV.div3A-M1 vs pre-existing or vector-induced immunity

Design

Preclinical experimental study

Key result

Engineered non-mammalian AAV capsids (AAV.div3A and div3A-M1) fully evaded neutralization and significantly increased therapeutic GAA levels upon redosing in a Pompe disease model.

Authors

ELE. LoebSFSophia FergioneVYVivian Yudistyra

Discussion

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Overview

Enables AAV redosing in Pompe models; leaves open human translation and safety trials.

Structured PICO

Does AAV.div3A enable gene therapy redosing by evading neutralizing antibodies in preclinical models?

P
Population
Mice (including a Pompe disease model) and in vitro screening
I
Intervention
AAV.div3A and AAV.div3A-M1 (engineered serologically distinct AAV capsids derived from non-mammalian dependoparvoviruses)
O
Outcome
Neutralizing antibody evasion, transduction efficiency, and therapeutic GAA levels upon redosingsurrogate

Engineered non-mammalian AAV capsids completely evade pre-existing neutralizing antibodies, enabling effective gene therapy redosing in preclinical models.

Cite This Study

Loeb et al. (2025) studied Pompe disease. AAV.div3A and div3A-M1 was evaluated on Therapeutic GAA levels. Engineered non-mammalian AAV capsids (AAV.div3A and div3A-M1) fully evaded neutralization and significantly increased therapeutic GAA levels upon redosing in a Pompe disease model.

synapsesocial.com/papers/6a62d8c41ec0c1a689b6d2d1https://doi.org/10.1016/j.xcrm.2025.102475
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