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First in human dose calculation of a single-chain bispecific antibody targeting glioma using the MABEL approach

J Immunother Cancer. 2020; 
Teilo H Schaller, David J Snyder, Ivan Spasojevic, Patrick C Gedeon, Luis Sanchez-Perez, John H Sampson
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Molecular Biology Reagents … with Protein-L-biotin (Genscript M00097) for 30 min at 4°C. Finally, after two more washes, cells were incubated with Streptavidin-PE (Biolegend 405204) for 30 min at 4°C. Cells were analyzed in a BD Fortessa flow cytometer. Fluorescence data were analyzed using Flowjo … Get A Quote

摘要

background: First-in-human (FIH) clinical trials require careful selection of a safe yet biologically relevant starting dose. Typically, such starting doses are selected based on toxicity studies in a pharmacologically relevant animal model. However, with the advent of target-specific and highly active immunotherapeutics, both the Food and Drug Administration and the European Medicines Agency have provided guidance that recommend determining a safe starting dose based on a minimum anticipated biological effect level (MABEL) approach. methods: We recently developed a T cell activating bispecific antibody that effectively treats orthotopic patient-derived malignant glioma and syngeneic glioblastoma in mice (hEGFR... More

关键词

immunology, neurooncology, oncology, pharmacokinetics