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Development trends for human monoclonal antibody therapeutics

Nelson, Aaron, Dhimolea, Eugen and Reichert, Janice (2010) Development trends for human monoclonal antibody therapeutics. Nature Reviews Drug Discovery, 9 (10). pp. 767-774. ISSN 1474-1776


Fully human monoclonal antibodies (mAbs) are a promising and rapidly growing category of targeted therapeutic agents. The first such agents were developed during the 1980s, but none achieved clinical or commercial success. Advances in technology to generate the molecules for study — in particular, transgenic mice and yeast or phage display — renewed interest in the development of human mAbs during the 1990s. Adalimumab was the first human mAb to be approved by the US Food and Drug Administration (FDA), in 2002, and an additional six human mAbs (panitumumab, golimumab, canakinumab, ustekinumab, ofatumumab and denosumab) have been FDA-approved since then. In addition, three candidates (raxibacumab, belimumab and ipilimumab) are currently in FDA review, seven are in Phase 3 studies, and 81 are in either Phase 1 or 2 studies. Here, we analyse data on 147 human mAbs that have entered clinical development to highlight trends in their development and approval and help inform future study of this class of therapeutic agents.

Item Type: Article
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Additional Information: Essentially, this entire project was complete before I began working at NIBR, while I was a student at Tufts University. The project was based on research I performed at the Tufts Center for the Study of Drug Development with Dr. Janice Reichert during the summer and fall of 2008. Indeed, this research yielded a previous publication with Dr. Reichert, for the work for which was performed in parallel. The manuscript was originally submitted to NRDD in the spring/summer of 2009. In the ensuing year, the manuscript has undergone several revisions, and several new pieces of data emerged. However, none were fundamental to the work. In addition, no NIBR resources whatsoever were utilized in this work.
Keywords: antibody, mAb, human, chimeric, humanized, humaneered, development,
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Date Deposited: 13 Oct 2015 13:16
Last Modified: 13 Oct 2015 13:16


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