nonclinical and clinical pharmacology, pharmacokinetics and pharmacodynamics of etrolizumab, an anti‐β7 integrin therapy for inflammatory bowel disease

…, ME Keir, R Erickson, EG Stefanich… - Alimentary …, 2018 - Wiley Online Library
Background Novel treatments with superior benefit‐risk profiles are needed to improve the
long‐term prognosis of patients with inflammatory bowel disease ( IBD ). Etrolizumab—a …

A humanized monoclonal antibody targeting the β7 integrin selectively blocks intestinal homing of T lymphocytes

EG Stefanich, DM Danilenko, H Wang… - British journal of …, 2011 - Wiley Online Library
… M Williams and EG Stefanich contributed equally to this manuscript. … therapy with corticosteroids
and immunomodulator therapy (eg azathioprine, 6-mercaptopurine and methotrexate) is …

Pre-clinical and translational pharmacology of a human interleukin-22 IgG fusion protein for potential treatment of infectious or inflammatory diseases

EG Stefanich, J Rae, S Sukumaran, J Lutman… - Biochemical …, 2018 - Elsevier
Interleukin (IL)-22 plays protective roles in infections and in inflammatory diseases that have
been linked to its meditation of innate immunity via multiple mechanisms. IL-22 binds …

Translational pharmacokinetics and pharmacodynamics of an FcRn‐variant anti‐CD4 monoclonal antibody from preclinical model to phase I study

…, C Woods, PJ Fielder, EG Stefanich - Clinical …, 2011 - Wiley Online Library
MTRX1011A is a humanized anti‐CD4 antibody with an amino acid substitution (N434H) to
improve its binding to the neonatal Fc receptor (FcRn). Pharmacokinetic/pharmacodynamic (…

Automated Affinity Capture and On-Tip Digestion to Accurately Quantitate in Vivo Deamidation of Therapeutic Antibodies

…, T Huang, K Reif, I Hotzel, EG Stefanich… - Analytical …, 2016 - ACS Publications
Deamidation of therapeutic antibodies may result in decreased drug activity and undesirable
changes in pharmacokinetics and immunogenicity. Therefore, it is necessary to monitor the …

A preclinical population pharmacokinetic model for anti‐CD20/CD3 T‐cell‐dependent bispecific antibodies

…, S Ramanujan, EG Stefanich - Clinical and …, 2018 - Wiley Online Library
CD20 is a cell‐surface receptor expressed by healthy and neoplastic B cells and is a well‐established
target for biologics used to treat B‐cell malignancies. Pharmacokinetic (PK) and …

[HTML][HTML] Nonclinical pharmacokinetics and pharmacodynamics characterization of anti-CD79B/CD3 T cell-dependent bispecific antibody using a surrogate molecule: a …

…, D Ellerman, C Spiess, A Polson, EG Stefanich… - Pharmaceutics, 2022 - mdpi.com
… development stages when there is limited data (eg, design and dose selection in multiple …
Our model with these features (eg, sequential binding and ternary complex formation) was …

Effect of antigen binding affinity and effector function on the pharmacokinetics and pharmacodynamics of anti-IgE monoclonal antibodies

DL Mortensen, S Prabhu, EG Stefanich… - MAbs, 2012 - Taylor & Francis
Modulating the binding affinities to IgE or changing the FcγR binding properties of anti-IgE
antibodies offers an opportunity to enhance the therapeutic potential of anti-IgE antibodies, …

Evidence for an asialoglycoprotein receptor on nonparenchymal cells for O-linked glycoproteins

EG Stefanich, S Ren, DM Danilenko, A Lim… - … of Pharmacology and …, 2008 - ASPET
B cell-activating factor receptor 3 (BR3)-Fc is an IgG1-receptor dimeric fusion protein that
has multiple O-linked glycosylation sites and sialylation levels that can vary in the …

[HTML][HTML] Utilizing PK and PD Biomarkers to Guide the First-in-Human Starting Dose Selection of MTBT1466A: A Novel Humanized Monoclonal Anti-TGFβ3 Antibody for …

…, JR Arron, L Pan, AV Kamath, EG Stefanich - Journal of …, 2023 - Elsevier
MTBT1466A is a high-affinity TGFβ3-specific humanized IgG1 monoclonal antibody with
reduced Fc effector function, currently under investigation in clinical trials as a potential anti-…