Results 71 to 80 of about 26,125 (257)

Prediction of Human Serum Concentration–Time Profiles of Golimumab and Ustekinumab Using Pharmacokinetic Data From Common Marmosets With Assessment of Anti‐Drug Antibodies

Biopharmaceutics &Drug Disposition, EarlyView.
This study identified new optimal allometric scaling exponents for human PK prediction of monoclonal antibodies with linear PKs from marmoset PK data. In addition, immunogenicity in common marmosets was evaluated following the repeated dose of golimumab and ustekinumab, minimal anti‐drug antibodies were detected.
Ayaka Tajiri, Shogo Matsumoto, Nanami Furukawa, Kensuke Kagiyama, Hiroshi Ikeda, Kazumasa Fukasawa, Hiroki Takano   +6 more
wiley   +1 more source

Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients

Clinical Pharmacology &Therapeutics, EarlyView.
ISB 2001 is a trispecific antibody that binds to two tumor‐associated antigens (TAA), CD38 and BCMA, and crosslinks to CD3 on T cells resulting in T cell‐mediated cytotoxicity of tumor cells expressing these TAAs. ISB 2001 is currently being tested in relapsed and/or refractory multiple myeloma (RRMM) patients in the first‐in‐human (FIH) TRIgnite‐1 ...
Vinu Chandralayam Ayyappa Menon, Tomomi Matsuura, Beata Holkova, Girish S. Gudi, Adam Drake, Maria Pihlgren, Piet H. van der Graaf, Sunitha GN, Andrew Garton, Mario Perro, Cyril Konto, Lida Pacaud   +11 more
wiley   +1 more source

Characterization of Lysosomal Hydrolases and Transporters and Their Age‐Dependent Variability: Relevance to Drug Metabolism and Transport of Small Molecule and Biologic Drugs

Clinical Pharmacology &Therapeutics, EarlyView.
Lysosomes play a key role in the accumulation, catabolism, and transport of endogenous and exogenous metabolites and proteins and are involved in drug metabolism and prodrug activation. However, the protein abundance and interindividual variability of lysosomal drug‐metabolizing enzymes and transporters (DMETs) remain underexplored.
Darshak Gadara, Dilip Kumar Singh, Sandhya Subash, Guihua Yue, Deepak Ahire, Chris Bohl, Maciej Czerwinski, Stephanie Helmstetter, Scott Heyward, Robert S. Jones, Cyrus Khojasteh, Ryota Kikuchi, Priyanka Kulkarni, Bin Ma, Bernard Murray, Chris Seib, Bill Smith, David M. Stresser, Mitchell E. Taub, Ting Wang, Bhagwat Prasad   +20 more
wiley   +1 more source

Structural and functional characterization of IgG- and non-IgG-based T-cell-engaging bispecific antibodies

Frontiers in Immunology
Bispecific T-cell-engaging antibodies are a growing class of therapeutics with numerous molecules being tested in clinical trials and, currently, seven of them have received market approval.
Nishant Mohan, Safiat Ayinde, Hanjing Peng, Shraboni Dutta, Yi Shen, Vincent M. Falkowski, Thomas G. Biel, Tongzhong Ju, Wen Jin Wu   +8 more
doaj   +1 more source

Patient‐Centric First‐in‐Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T‐Cell Engagers in Multiple Myeloma

Clinical Pharmacology &Therapeutics, EarlyView.
The minimal anticipated biological effect level (MABEL) approach to first‐in‐human (FIH) dose calculation can lead to long dose‐escalation periods before observing clinical activity. We used a novel ex vivo MABEL approach to calculate the FIH starting dose for forimtamig, a T‐cell bispecific antibody under investigation for the treatment of relapsed ...
Thomas E. Kraft, Estelle Marrer‐Berger, Sara Belli, Helene Haegel, Anneliese Schneider, Anna Maria Giusti, Michael Bscheider, Wolfgang Jacob, Martin Weisser, Laura Blanco, Nicolas Frances, Eva Rossmann, Guido Steiner, Aintzane Zabaleta Azpiroz, Bruno Paiva, Ludovic Martinet, Tanja Fauti   +16 more
wiley   +1 more source

Nonclinical immunogenicity risk assessment for knobs-into-holes bispecific IgG1 antibodies

mAbs
Bispecific antibodies, including bispecific IgG, are emerging as an important new class of antibody therapeutics. As a result, we, as well as others, have developed engineering strategies designed to facilitate the efficient production of bispecific IgG ...
Wen-Ting K. Tsai, Yinyin Li, Zhaojun Yin, Peter Tran, Qui Phung, Zhenru Zhou, Kun Peng, Dan Qin, Sien Tam, Christoph Spiess, Jochen Brumm, Manda Wong, Zhengmao Ye, Patrick Wu, Sivan Cohen, Paul J. Carter   +15 more
doaj   +1 more source

The evolution of bispecific antibodies [PDF]

Expert Opinion on Biological Therapy, 2022
openaire   +2 more sources

Flow cytometry‐based monitoring of chimeric antigen receptor (CAR) T cells: Reagent selection, assay design, and clinical utility

Cytometry Part B: Clinical Cytometry, EarlyView.
Abstract Accurate quantification of chimeric antigen receptor (CAR) T cells is essential for monitoring post‐infusion CART expansion and persistence and for real‐time clinical decision‐making. Multiparameter flow cytometry (MFC) enables rapid, live‐cell detection with absolute quantification and concurrent immunophenotypic characterization. This review
Jianhua Ling, Wei Wang, Sa A. Wang
wiley   +1 more source

Novel Organelle‐Based Intracellular Immunity With Mechanistic and Therapeutic Implications

Barrier Immunity, EarlyView.
A conceptual framework illustrating how PAMPs/DAMPs initiate barrier, innate, adaptive, and intracellular immune responses, with organelle‐based intracellular immunity serving as a central integrator linking metabolism, inflammatory signaling, and therapeutic interventions to restore immune homeostasis.
Keman Xu, Shih‐Yu Hung, Fatma Saaoud, Ying Shao, Yifan Lu, Juanjuan Liu, Bo Yuan, Haiyan Xiang, Hong Wang, Xiaofeng Yang   +9 more
wiley   +1 more source

Chemical-Assembled Macrophage-Engaging Glypican-3 × Signal Regulatory Protein-α (SIRP-α) Bispecific Antibody for Immunotherapy Against Liver Cancer. [PDF]

MedComm (2020)
We developed a novel chemical strategy to generate a glypican‐3 × SIRP‐α bispecific antibody that simultaneously blocks the CD47 “don't eat me” signal, engages macrophages to target liver cancer cells for enhanced phagocytosis, and antigen presentation. This novel combination of targets demonstrates remarkable efficacy in vitro and in vivo.
Tang B, Leung WH, Shao C, Li D, Lau KM, Lui MKH, Liu J, Chu JCH, Yan CSW, Che CM, Li X, Wong WT, Chow LMC, Lee TKW, Wong CTT.   +14 more
europepmc   +2 more sources