Correction: VTX-PID as a novel recombinant immunoglobulin G–degrading enzyme (IdeS) for efficient AAV-based gene therapy in participants with neutralizing antibodies: results of the phase I first-in-human NAVIgATE study - Report - MDSpire

Correction: VTX-PID as a novel recombinant immunoglobulin G–degrading enzyme (IdeS) for efficient AAV-based gene therapy in participants with neutralizing antibodies: results of the phase I first-in-human NAVIgATE study

  • By

  • Bernard Benichou

  • Rainard Fuhr

  • Elodie Vernadal

  • Sonia Valero

  • Blanche Tamarit

  • Veronica Ferrer

  • Gloria Gonzalez-Aseguinolaza

  • Anne Douar

  • Marc Froissart

  • Annelise Brossel

  • Simone Floettmann

  • Francesca Del Bene

  • Céline Bouquet

  • Jean-Philippe Combal

  • June 17, 2026

  • 0 min

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Clinical Report: Correction on VTX-PID for AAV-Based Gene Therapy

Overview

This report addresses a correction regarding VTX-PID, a recombinant immunoglobulin G-degrading enzyme, which is crucial for enhancing AAV-based gene therapy in subjects with neutralizing antibodies. The Phase I NAVIgATE trial demonstrated the enzyme's potential to reduce anti-AAV3B neutralizing antibodies, facilitating gene transfer.

Background

Neutralizing antibodies (NAbs) against adeno-associated virus (AAV) can significantly impede the efficacy of AAV-mediated gene therapies. VTX-PID (imlifidase) has emerged as a promising solution by selectively degrading IgG antibodies, thereby potentially overcoming this barrier. The NAVIgATE trial represents a significant step in evaluating this innovative approach in a clinical setting.

Data Highlights

No numerical data or trial results are provided in the correction notice.

Key Findings

  • Correction of Figure 4C to accurately reflect the negativity threshold for NAbs.
  • Omission of writing assistance acknowledgment in the original publication has been rectified.
  • The NAVIgATE trial demonstrated that VTX-PID can create a transient window of NAb negativity.
  • 0.3 mg/kg was identified as the appropriate dose for further studies following observed ALT elevations at 0.6 mg/kg.
  • Clinical implications of VTX-PID include enabling AAV therapy in previously ineligible patients due to NAbs.

Clinical Implications

The findings underscore the importance of addressing pre-existing NAbs in patients undergoing AAV gene therapy. VTX-PID may provide a viable strategy to enhance treatment eligibility and efficacy in this patient population.

Conclusion

The correction highlights critical updates regarding the NAVIgATE trial and reinforces the potential of VTX-PID in facilitating AAV-based gene therapies. Continued research is essential to fully understand its clinical applications.

Related Resources & Content

  1. Benichou B et al., Frontiers in Immunology, 2026 -- Correction: VTX-PID as an Innovative Recombinant Immunoglobulin G-Degrading Enzyme
  2. Retinal Physician — Gene Therapy for Neovascular AMD
  3. Ophthalmology Management — FDA Approves ViGeneron’s IND for Gene Therapy That Targets Stargardt Disease, ABCA4-Linked Retinal Conditions
  4. Retinal Physician — ViGeneron Receives FDA Clearance
  5. Premarket Approval (PMA)
  6. Frontiers | VTX-PID as a novel recombinant immunoglobulin G–degrading enzyme (IdeS) for efficient AAV-based gene therapy in participants with neutralizing antibodies: results of the phase I first-in-human NAVIgATE study
  7. Global seroprevalence of neutralizing antibodies against adeno-associated virus serotypes used for human gene therapies - ScienceDirect

Original Source(s)

Correction: VTX-PID as a novel recombinant immunoglobulin G–degrading enzyme (IdeS) for efficient AAV-based gene therapy in participants with neutralizing antibodies: results of the phase I first-in-human NAVIgATE study

  • by Bernard Benichou, Rainard Fuhr, Elodie Vernadal, Sonia Valero, Blanche Tamarit, Veronica Ferrer, Gloria Gonzalez-Aseguinolaza, Anne Douar, Marc Froissart, Annelise Brossel, Simone Floettmann, Francesca Del Bene, Céline Bouquet, Jean-Philippe Combal

  • June 17, 2026

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