This authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Fourteen comprehensive chapters are divided into six sections including an introduction to ADCs, the ADC construct, development issues, landscape, IP and pharmacoeconomics, case studies, and the future of the field. The book examines everything from the selection of the antibody, the drug, and the linker to a discussion of developmental issues such as formulations, bio-analysis, pharmacokinetic-pharmacodynamic relationships, and toxicological and regulatory challenges. It also explores pharmacoecomonics and intellectual properties, including recently issued patents and the cost analysis of drug therapy. Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg®), Brentuximab vedotin (Adcetris®), and ado-trastuzumab emtansine (Kadcyla®), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011). Finally, the volume presents a perspective by the editors on the future directions of ADC development and clinical applications. Antibody-Drug Conjugates is a practical and systematic resource for scientists, professors, and students interested in expanding their knowledge of cutting-edge research in this exciting field.

Provides in-depth discussions on factors impacting development of antibody-drug conjugates Offers practical considerations in constructing antibody-drug conjugates Summarizes current antibody-drug conjugate programs and proposes future directions

Autorentext

Dr. Jeffrey Wang received his PhD in pharmaceutical sciences from the University of Southern California in Los Angeles. Dr. Wang's research focuses on the application of principles of pharmacokinetics and drug metabolism in drug discovery and delivery, particularly in anti-cancer drug discovery and peptide and protein drug delivery. He has published more than 100 peer-reviewed articles, book chapters and meeting abstracts and is the co-inventor of several U.S. and international patents. Dr. Wang is currently Associate Professor of Pharmaceutical Sciences and Director of Graduate Education at the College of Pharmacy, Western University of Health Sciences, Pomona, California.

Dr. Wei-Chiang Shen is John A. Biles Professor in Pharmaceutical Sciences at the University of Southern California's School of Pharmacy in Los Angeles. Dr. Shen received his PhD in bio-organic chemistry from Boston University, Massachusetts. He has many years of experience on the conjugation of drug to macromolecules, including poly (amino acids), transferrin and antibodies. His current focus of research is on recombinant fusion proteins and cell-penetrating peptides. Dr. Shen has published about 150 papers, mostly in the area of drug delivery. He is an inventor or co-inventor of 16 issued U.S. patents and a Fellow of the American Association of Pharmaceutical Scientists and the American Association for the Advancement of Science.

Dr. Jennica L. Zaro is a Research Assistant Professor at the School of Pharmacy, University of Southern California, Los Angeles. Her main research projects are focused on targeted delivery of peptide and protein drugs and on recombinant bifunctional fusion proteins as therapeutics. Dr. Zaro is also the Core Director of the Translational Research Laboratory. Prior to joining the university, Dr. Zaro received her PhD in pharmaceutical sciences from the University of Southern California, where she focused on the design and characterization of peptide carriers for protein drugs. In addition, she has held several roles in the pharmaceutical industry, where she developed formulations for aerosol products and designed and validated analytical methods for protein drugs.

Inhalt

1 Antibody-Drug Conjugates: A Historical Review.- 2 Payloads of Antibody-Drug Conjugates.- 3 Selecting an Optimal Antibody for Antibody-Drug Conjugate Therapy.- 4 Linker Design for Antibody-Drug Conjugates.- 5 Formulation Development for Antibody-Drug Conjugates.- 6 Bioanalytical Assay for Characterization of Antibody Drug Conjugates.- 7 Pharmacokinetics/Pharmacodynamics and Disposition of Antibody-Drug Conjugates.- 8 Regulatory Considerations.- 9 Major ADC Companies, Current Clinical Trials, Recent Patents Issued and Patent Applications, and Cost Analysis of Drug Therapy.- 10 Mylotarg: Revisiting its Clinical Potential Post-Withdrawal.- 11 ADCETRIS: A Regulatory Case Study of a New Generation Antibody Drug Conjugate.- 12 Ado-Trastuzumab Emtansine.- 13 The Antibody-Drug Conjugate Glembatumumab Vedotin (CDX-011) and its Use in Treatment of Breast Cancer.- 14 Summary and Future Directions.