The menace of severe adverse events and deaths associated with viral gene therapy and its potential solution

A Kachanov, A Kostyusheva, S Brezgin… - Medicinal Research …, 2024 - Wiley Online Library
Over the past decade, in vivo gene replacement therapy has significantly advanced,
resulting in market approval of numerous therapeutics predominantly relying on adeno …

Role of FoxP3+ Regulatory T Cells in Modulating Immune Responses to Adeno-Associated Virus Gene Therapy

M Muñoz-Melero, M Biswas - Human Gene Therapy, 2024 - liebertpub.com
Adeno-associated virus (AAV) gene therapy is making rapid strides owing to its wide range
of therapeutic applications. However, development of serious immune responses to the …

Valoctocogene roxaparvovec gene therapy provides durable haemostatic control for up to 7 years for haemophilia A

E Symington, S Rangarajan, W Lester, B Madan… - …, 2024 - Wiley Online Library
Introduction Valoctocogene roxaparvovec is an adeno‐associated virus vector serotype 5
(AAV5)‐mediated gene therapy approved for severe haemophilia A (HA). Aim To report the …

[HTML][HTML] Immune responses to central nervous system directed adeno-associated virus gene therapy: Does direct CNS delivery make a difference?

AL Harkins, PP Ambegaokar, AM Keeler - Neurotherapeutics, 2024 - Elsevier
Adeno-associated virus (AAV) mediated gene therapy is a leading gene delivery platform
with potential to transform the landscape of treatment for neurological disorders. While AAV …

Essential role of pre-existing humoral immunity in TLR9-mediated type I IFN response to recombinant AAV vectors in human whole blood

NS Alakhras, CA Moreland, LC Wong, P Raut… - Frontiers in …, 2024 - frontiersin.org
Recombinant adeno-associated virus (AAV) vectors have emerged as the preferred platform
for gene therapy of rare human diseases. Despite the clinical promise, host immune …

Clinical Pharmacology Perspective on Development of Adeno‐Associated Virus Vector‐Based Retina Gene Therapy

JL Ford, E Karatza, H Mody… - Clinical …, 2024 - Wiley Online Library
Adeno‐associated virus (AAV) vector‐based gene therapy is an innovative modality being
increasingly investigated to treat diseases by modifying or replacing defective genes or …

Human cell surface-AAV interactomes identify LRP6 as blood-brain-barrier transcytosis receptor and immune cytokine IL3 as AAV9 binder

TF Shay, S Jang, X Chen, B Walker, C Tebbutt… - bioRxiv, 2024 - biorxiv.org
Adeno-associated viruses (AAVs) are foundational gene delivery tools for basic science and
clinical therapeutics. However, lack of mechanistic insight, especially for engineered vectors …

Immunogenicity Risk Assessment of Process-Related Impurities in An Engineered T Cell Receptor Cellular Product

J Mora, D Forman, J Hu, A Ijantkar, J Gokemeijer… - Journal of …, 2024 - Elsevier
Cell therapies such as genetically modified T cells have emerged as a promising and viable
treatment for hematologic cancers and are being aggressively pursued for a wide range of …

Development of an Enzyme-Linked Immunosorbent Spot Assay for the Assessment of Adeno-Associated Virus Peptides to Examine Immune Safety

SR Krivoshik, L Dzielak, AR Masters, J Hall… - Human Gene …, 2024 - liebertpub.com
Adeno-associated virus (AAV)-based gene therapies have shown promise as novel
treatments for rare genetic disorders such as hemophilia A and spinal muscular atrophy …

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV …

J Mora, R Palmer, L Wagner, B Wu, M Partridge… - Bioanalysis, 2024 - Taylor & Francis
The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL,
USA on June 19–23, 2023. Over 1000 professionals representing pharma/biotech …