Rationale for using centralized transduction inhibition assays in three phase 3 rAAV gene therapy clinical trials

Author:

Schulz Martin,Bashirians George,Cheng Seng H.,Levy Daniel I.,Lundie Mark,Wilcox Lisa,Winburn Ian,Somanathan SuryanarayanORCID

Funder

Pfizer

Publisher

Elsevier BV

Subject

Genetics,Molecular Biology,Molecular Medicine

Reference26 articles.

1. Binding and neutralizing anti-AAV antibodies: Detection and implications for rAAV-mediated gene therapy;Schulz;Mol. Ther.,2023

2. Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays;Gorovits;AAPS J.,2020

3. Measuring immune responses to recombinant AAV gene transfer;Martino;Methods Mol. Biol.,2011

4. A Study to Evaluate the Safety and Tolerability of PF-06939926 Gene Therapy in Duchenne Muscular Dystrophy,2017

5. Study to Evaluate the Efficacy and Safety of PF-07055480/Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults,2020

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