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Akademický článek

Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper

Autor: Tong-yuan Yang, Manuela Braun, Wibke Lembke, Fraser McBlane, John Kamerud, Stephen DeWall, Edit Tarcsa, Xiaodong Fang, Lena Hofer, Uma Kavita, Vijay V. Upreti, Swati Gupta, LiNa Loo, Alison J. Johnson, Rakesh Kantilal Chandode, Kay-Gunnar Stubenrauch, Maya Vinzing, Cindy Q. Xia, Vibha Jawa

Publikováno v: Molecular Therapy: Methods & Clinical Development, Vol 26, Iss , Pp 471-494 (2022)

Immunogenicity has imposed a challenge to efficacy and safety evaluation of adeno-associated virus (AAV) vector-based gene therapies. Mild to severe adverse events observed in clinical development have been implicated with host immune responses again

Externí odkaz: https://doaj.org/article/1b85bb2274f44631a3d3b829f5704b0f

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Akademický článek

Immunopotentiation of trivalent influenza vaccine when given with VAX102, a recombinant influenza M2e vaccine fused to the TLR5 ligand flagellin.

Autor: H Keipp Talbot, Michael T Rock, Casey Johnson, Lynda Tussey, Uma Kavita, Anita Shanker, Alan R Shaw, David N Taylor

Publikováno v: PLoS ONE, Vol 5, Iss 12, p e14442 (2010)

Currently controversy exists about the immunogenicity of seasonal trivalent influenza vaccine in certain populations, especially the elderly. STF2.4×M2e (VAX102) is a recombinant fusion protein that links four copies of the ectodomain of influenza v

Externí odkaz: https://doaj.org/article/550b5e48d91d4fefa80b68e11c54062c

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Akademický článek

Efficacious recombinant influenza vaccines produced by high yield bacterial expression: a solution to global pandemic and seasonal needs.

Publikováno v: PLoS ONE, Vol 3, Iss 5, p e2257 (2008)

It is known that physical linkage of TLR ligands and vaccine antigens significantly enhances the immunopotency of the linked antigens. We have used this approach to generate novel influenza vaccines that fuse the globular head domain of the protectiv

Externí odkaz: https://doaj.org/article/6ba45ece307a49aabda85d5795843da3

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BMS‐986263 in patients with advanced hepatic fibrosis: 36‐week results from a randomized, placebo‐controlled phase 2 trial

Autor: Shuyan Du, Diane E. Shevell, Warner Chen, Edgar D. Charles, Uma Kavita, Angie Coste, Fred Poordad, Zachary Goodman, Eric Lawitz, Mette Juul Nielsen, Giridhar S. Tirucherai, Morten A. Karsdal

Publikováno v: Hepatology. 75:912-923

Background & aims Hepatic fibrosis secondary to HCV infection can lead to cirrhosis and hepatic decompensation. Sustained virologic response (SVR) is possible with direct-acting antiviral drug regimens; however, patients with advanced fibrosis have a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e802021fa75e6b6ce3e5c628a8f75647
https://doi.org/10.1002/hep.32181

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Prevalence of Pre-Existing Neutralizing Antibodies Against Adeno-Associated Virus Serotypes 1, 2, 5, 6, 8, and 9 in Sera of Different Pig Strains

Autor: Yanshan Dai, Uma Kavita, Margit H. Lampen, Sander Gielen, Glen Banks, Paul Levesque, Alexander Kozhich, Renuka Pillutla, Yan Zhang, Vibha Jawa, Leonard Adam

Publikováno v: Human gene therapy. 33(7-8)

Pre-existing neutralizing antibodies (NAb) to adeno-associated virus (AAV) may diminish the efficacy of AAV-based therapies depending on the titer. To support gene therapy studies in pigs, the seroprevalence of NAb to AAV1, 2, 5, 6, 8, and 9 serotype

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a0305af41d3a11a05e27cc9f4d602127
https://pubmed.ncbi.nlm.nih.gov/34913759

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Development of a Chemiluminescent ELISA Method for the Detection of Total Anti-Adeno Associated Virus Serotype 9 (AAV9) Antibodies

Autor: Yan-Shan Dai, Lisa Salvador, Paul Levesque, Uma Kavita, Qin C Ji, Wendy Miller, Yan J Zhang, Renuka Pillutla, Leonard P. Adam

Publikováno v: Human Gene Therapy Methods. 29:237-250

Recombinant adeno associated viruses (rAAV) have become an important tool for the delivery of gene therapeutics due to long-standing safety and success in clinical trials. Since humans often become exposed to AAVs and develop anti-AAV antibodies (Abs

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e88775e17f31316680262df4447b2c0e
https://doi.org/10.1089/hgtb.2018.131

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A Fit-for-Purpose Method for the Detection of Human Antibodies to Surface-Exposed Components of BMS-986263, a Lipid Nanoparticle-Based Drug Product Containing a siRNA Drug Substance

Autor: Wendy Miller, Uma Kavita, Renuka Pillutla, Qin C Ji

Publikováno v: The AAPS journal. 21(5)

ND-L02-s0201/BMS-986263 is a lipid nanoparticle (LNP) drug product containing a heat shock protein 47 (HSP47)–specific small interfering ribonucleic acid (siRNA) and being developed for the treatment of liver and idiopathic pulmonary fibrosis. To a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e4c1a6b47346b1f03a8679b0e0163738
https://pubmed.ncbi.nlm.nih.gov/31332587

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A systematic study of the effect of low pH acid treatment on anti-drug antibodies specific for a domain antibody therapeutic: Impact on drug tolerance, assay sensitivity and post-validation method assessment of ADA in clinical serum samples

Autor: Carol Gleason, Rong Liu, Robert Dodge, Huijin Dong, Jia Duo, Joan Valcin, Binodh DeSilva, Snaehal Gadkari, Renuka Pillutla, Uma Kavita, Sean M. Crawford

Publikováno v: Journal of immunological methods. 448

We developed a homogeneous bridging anti-drug antibody (ADA) assay on an electro chemiluminescent immunoassay (ECLIA) platform to support the immunogenicity evaluation of a dimeric domain antibody (dAb) therapeutic in clinical studies. During method

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::98092e4753ff4647adaafef84eb5bb19
https://pubmed.ncbi.nlm.nih.gov/28625864

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