Results 81 to 90 of about 27,196 (258)

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐07261271 in healthy participants

British Journal of Clinical Pharmacology, EarlyView.
Aim There is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF‐07261271, a bispecific antibody targeting both the p40 subunit of interleukin‐12/23 and tumour necrosis factor‐like cytokine 1A ...
Srividya Neelakantan, Christopher Banfield, Kenneth Hung, Anna Sapone, Vivek Pradhan, Yuxi Zhao, Dana Parsons‐Rich, Grace Lee, Bryce G. Johnson, Elena Peeva, Michael S. Vincent, Valerie M. Clerin   +11 more
wiley   +1 more source

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

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

Overcoming the Constraints of Anti-HIV/CD89 Bispecific Antibodies That Limit Viral Inhibition

Journal of Immunology Research, 2016
Innovative strategies are necessary to maximize the clinical application of HIV neutralizing antibodies. To this end, bispecific constructs of human antibody F240, reactive with well-conserved gp41 epitope and antibody 14A8, reactive with the IgA ...
Xiaocong Yu, Mark Duval, Melissa Gawron, Marshall R. Posner, Lisa A. Cavacini   +4 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

The German ONKOPEDIA Guideline for Myelofibrosis in 2025—Recommendations of an MPN Expert Panel of the German Society for Hematology and Oncology (DGHO)

International Journal of Cancer, EarlyView.
ABSTRACT The recently published ONKOPEDIA guideline on myelofibrosis, issued under the auspices of the German Society of Hematology and Oncology (DGHO), provides an updated, evidence‐based framework for the diagnosis and management of this rare, chronic myeloproliferative neoplasm.
Martin Griesshammer, Haifa Kathrin Al‐Ali, Gabriela M. Baerlocher, Konstanze Döhner, Steffen Koschmieder, Nicolaus Kröger, Petro E. Petrides, Dominik Wolf, Florian H. Heidel   +8 more
wiley   +1 more source