Pai‐Hsi Huang

Viral Kinetics Model of SARS‐CoV‐2 Infection Informs Drug Discovery, Clinical Dose, and Regimen Selection

Allison Claas, Meelim J. Lee, Pai‐Hsi Huang, Charles G. Knutson et autres

Quantitative systems pharmacology (QSP) has been an important tool to project safety and efficacy of novel or repurposed therapies for the SARS-CoV-2 virus. Here, we present a QSP modeling framework to predict response to antiviral therapeutics with three mechanisms of action (MoA): …

cn, us, ch (code pays fourni par la source)

Model‐based dose selection to inform translational clinical oncology development of WNT974 , a first‐in‐class Porcupine inhibitor

Yan Ji, Pai‐Hsi Huang, Steve Woolfenden, Andrea Pomrehn Myers

WNT974 is a potent, selective, and orally bioavailable first-in-class inhibitor of Porcupine, a membrane-bound O-acyltransferase required for Wnt secretion, currently under clinical development in oncology. A phase I clinical trial is being conducted in patients with advanced solid tumors. During the dose-escalation …

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Tisagenlecleucel Model‐Based Cellular Kinetic Analysis of Chimeric Antigen Receptor–T Cells

Andrew Marc Stein, Stephan A. Grupp, John E. Levine, Theodore Willis Laetsch et autres

B cells. A model was developed for the kinetics of tisagenlecleucel and the impact of therapies for treating cytokine release syndrome (tocilizumab and corticosteroids) on expansion. Data from two phase II studies in pediatric and young adult relapsed/refractory B cell acute lymphoblastic …

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CTL019 Model-Based Cellular Kinetic Analysis of Chimeric Antigen Receptor (CAR) T Cells to Characterize the Impact of Tocilizumab on Expansion and to Identify Correlates of Cytokine Release Syndrome Severity

Andrew Marc Stein, Stephan A. Grupp, John E. Levine, Theodore Willis Laetsch et autres

Background: CTL019 is an investigational therapy whereby autologous T cells are genetically engineered with a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant B cells. Data from two phase 2 studies (ELIANA; NCT02435849 and ENSIGN; NCT02228096) in pediatric and young …

us, ch (code pays fourni par la source)

Population Pharmacokinetics of Ceritinib in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase

Ying Sen Hong, Vanessa Q. Passos, Pai‐Hsi Huang, Yvonne Y. Lau

Abstract Ceritinib is a second‐generation selective and potent oral anaplastic lymphoma kinase (ALK) inhibitor approved for ALK‐positive advanced non–small cell lung cancer previously treated with crizotinib. Population pharmacokinetic (PK) analysis was performed to describe the PK of ceritinib and was used to …

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Population pharmacokinetics of sonidegib (LDE225), an oral inhibitor of hedgehog pathway signaling, in healthy subjects and in patients with advanced solid tumors

Varun Goel, Eunju Hurh, Andrew Marc Stein, Jerry R. Nedelman et autres

us, ch (code pays fourni par la source)