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PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1.
AAPS J. 2023.
PMID: 37523051
Review.
Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Yang TY, Braun M, Lembke W, McBlane F, Kamerud J, DeWall S, Tarcsa E, Fang X, Hofer L, Kavita U, Upreti VV, Gupta S, Loo L, Johnson AJ, Chandode RK, Stubenrauch KG, Vinzing M, Xia CQ, Jawa V.
Yang TY, et al. Among authors: lembke w.
Mol Ther Methods Clin Dev. 2022 Aug 2;26:471-494. doi: 10.1016/j.omtm.2022.07.018. eCollection 2022 Sep 8.
Mol Ther Methods Clin Dev. 2022.
PMID: 36092368
Free PMC article.
Review.
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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Loo L, Harris S, Milton M, Meena, Lembke W, Berisha F, Bertholet S, Dessy F, Dodge R, Fang X, Fiscella M, Garofolo F, Gorovits B, Gupta S, Jawa V, Ishii-Watabe A, Long B, Lu Y, Mack T, McGuire K, Nolan K, Pan L, Potthoff B, Purushothama S, Smith D, Solstad T, Sonderegger I, Taddeo F, Tangri S, Wagner L, Wu B, Xu Y, Kirshner S, Verthelyi D, Yan H, Maxfield K, Pedras-Vasconcelos J, Abhari MR, Gupta S, Wu Y, Rajadhyaksha M, Andisik M, Baltrukonis D, Cherry E, Cludts I, Gunn G, Millner AH, Jordan G, Kar S, Kubiak R, Lotz GP, Palmer R, Peng K, Poetzl J, Richards S, Savoie N, Staack RF, Stubenrauch K, Wadhwa M, Waxenecker G, Yang TY, Zhang L.
Loo L, et al. Among authors: lembke w.
Bioanalysis. 2022 Jun;14(11):737-793. doi: 10.4155/bio-2022-0081. Epub 2022 May 17.
Bioanalysis. 2022.
PMID: 35578991
Free article.
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Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
Braun M, Lange C, Schatz P, Long B, Stanta J, Gorovits B, Tarcsa E, Jawa V, Yang TY, Lembke W, Miller N, McBlane F, Christodoulou L, Yuill D, Milton M.
Braun M, et al. Among authors: lembke w.
Mol Ther Methods Clin Dev. 2024 Feb 20;32(1):101217. doi: 10.1016/j.omtm.2024.101217. eCollection 2024 Mar 14.
Mol Ther Methods Clin Dev. 2024.
PMID: 38496304
Free PMC article.
Review.
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COVA4231, a potent CD3/CD33 bispecific FynomAb with IgG-like pharmacokinetics for the treatment of acute myeloid leukemia.
Klupsch K, Baeriswyl V, Scholz R, Dannenberg J, Santimaria R, Senn D, Kage E, Zumsteg A, Attinger-Toller I, von der Bey U, König-Friedrich S, Dupuy F, Lembke W, Albani C, Wendelspiess S, Dinkel L, Saro D, Hepler RW, Laszlo GS, Gudgeon CJ, Bertschinger J, Brack S, Walter RB.
Klupsch K, et al. Among authors: lembke w.
Leukemia. 2019 Mar;33(3):805-808. doi: 10.1038/s41375-018-0249-z. Epub 2018 Sep 11.
Leukemia. 2019.
PMID: 30206306
No abstract available.
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Discovery and characterization of COVA322, a clinical-stage bispecific TNF/IL-17A inhibitor for the treatment of inflammatory diseases.
Silacci M, Lembke W, Woods R, Attinger-Toller I, Baenziger-Tobler N, Batey S, Santimaria R, von der Bey U, Koenig-Friedrich S, Zha W, Schlereth B, Locher M, Bertschinger J, Grabulovski D.
Silacci M, et al. Among authors: lembke w.
MAbs. 2016;8(1):141-9. doi: 10.1080/19420862.2015.1093266. Epub 2015 Sep 22.
MAbs. 2016.
PMID: 26390837
Free PMC article.
Clinical Trial.
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Linker length matters, fynomer-Fc fusion with an optimized linker displaying picomolar IL-17A inhibition potency.
Silacci M, Baenziger-Tobler N, Lembke W, Zha W, Batey S, Bertschinger J, Grabulovski D.
Silacci M, et al. Among authors: lembke w.
J Biol Chem. 2014 May 16;289(20):14392-8. doi: 10.1074/jbc.M113.534578. Epub 2014 Apr 1.
J Biol Chem. 2014.
PMID: 24692552
Free PMC article.
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