Sevilla, October 2025 – At the 32nd Annual Congress of the European Society of Gene & Cell Therapy (ESGCT), Vivet Therapeutics shared new clinical data with its VTX-PID proprietary imlifidase formulation, highlighting the effective reduction of neutralizing antibodies (NAbs) against AAV3B in healthy volunteers.
Key Findings:
- In naturally immunized populations, targeted intervention reduced anti-AAV3B NAbs to non-inhibitory levels in a significant portion of participants, a critical threshold for enabling subsequent AAV3B-based gene therapy.
- These results, validated with dose-ranging and PK/PB modeling, indicate that a meaningful proportion of the general population—previously ineligible due to pre-existing immunity—may become candidates for AAV3B gene therapy.
- This strategy is poised to expand access to transformative gene therapies by overcoming one of the main immunological barriers to treatment.
- We believe that these results open new perspectives for expanding safe and effective gene therapy to broader patient groups, and pave the way for clinical translation across multiple indications and AAVs.
- Moreover, preliminary data presented by Genethon on Crigler Najar patients AAV8 NAbs positive, demonstrate such approach as clinically relevant although requested longer time outcome to ensure sustainability upon inclusion criteria such as NAbs baseline
Vivet Therapeutics remains committed to advancing innovative therapies and supporting the gene therapy community’s progress toward greater patient access and improved clinical outcomes with VTX-PID ownership across the CMC package, including manufacturing process, non-clinical package & full clinical PK/PB model from Phase 1 dataset.
