The birth pangs of monoclonal antibody therapeutics
Open Access
- 1 May 2012
- journal article
- review article
- Published by Informa UK Limited in mAbs
- Vol. 4 (3), 403-412
- https://doi.org/10.4161/mabs.19909
Abstract
This paper examines the development and termination of nebacumab (Centoxin®), a human IgM monoclonal antibody (mAb) drug frequently cited as one of the notable failures of the early biopharmaceutical industry. The non-approval of Centoxin in the United States in 1992 generated major concerns at the time about the future viability of any mAb therapeutics. For Centocor, the biotechnology company that developed Centoxin, the drug posed formidable challenges in terms of safety, clinical efficacy, patient selection, the overall economic costs of health care, as well as financial backing. Indeed, Centocor's development of the drug brought it to the brink of bankruptcy. This article shows how many of the experiences learned with Centoxin paved the way for the current successes in therapeutic mAb development.Keywords
This publication has 64 references indexed in Scilit:
- Sepsis: rethinking the approach to clinical researchJournal of Leukocyte Biology, 2008
- Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolutionPostgraduate Medical Journal, 2007
- The three pillars of bioentrepreneurshipNature Biotechnology, 1998
- Side-effects of a monoclonal antibody, muromonab CD3/orthoclone OKT3: bibliographic reviewToxicology, 1995
- Perspectives for the futureIntensive Care Medicine, 1993
- Association between protective efficacy of anti-lipopolysaccharide (LPS) antibodies and suppression of LPS-induced tumor necrosis factor alpha and interleukin 6. Comparison of O side chain-specific antibodies with core LPS antibodies.The Journal of Experimental Medicine, 1990
- Antibody engineeringPhilosophical Transactions of the Royal Society of London. B, Biological Sciences, 1989
- EVOLVING USE OF OKT3 MONOCLONAL ANTIBODY FOR TREATMENT OF RENAL ALLOGRAFT REJECTIONTransplantation, 1984
- Treatment of Gram-Negative Bacteremia and Shock with Human Antiserum to a MutantEscherichia coliNew England Journal of Medicine, 1982
- The Wellcome Foundation Lecture, 1980 - Monoclonal antibodies from hybrid myelomasProceedings of the Royal Society of London. B. Biological Sciences, 1981