Antibodies to watch in 2010
- 1 January 2010
- journal article
- Published by Informa UK Limited in mAbs
- Vol. 2 (1), 84-100
- https://doi.org/10.4161/mabs.2.1.10677
Abstract
Monoclonal antibodies (mAbs) are a burgeoning class of therapeutics, with more than 25 approved in countries worldwide. Novel molecules are entering clinical study at a rate of nearly 40 per year, and the commercial pipeline includes approximately 240 mAb therapeutics in clinical studies that have not yet progressed to regulatory approval or been approved. Of particular interest are the 26 mAbs that are currently at Phase 3, when safety and efficacy data critical to approval is established. Phase 3 study lengths are typically two to four years, so results for some studies might be announced in 2010, but data from others might not be presented until 2014. This overview of the 26 candidates provides a brief description of the background and the on-going Phase 3 studies of each mAb. Additional mAbs that have progressed to regulatory review or been approved may also be in Phase 3 studies, but these, as well as Fc fusion proteins, have been excluded. Due to the large body of primary literature about the 26 candidates, only selected references are given, with a focus on recent publications and articles that were relevant to Phase 3 studies. Current as of October 2009, the results presented here will serve as a baseline against which future progress can be measured.Keywords
This publication has 56 references indexed in Scilit:
- Phase I Dose Escalation, Pharmacokinetic and Pharmacodynamic Study of Naptumomab Estafenatox Alone in Patients With Advanced Cancer and With Docetaxel in Patients With Advanced Non–Small-Cell Lung CancerJournal of Clinical Oncology, 2009
- A phase II, randomized, double‐blind, placebo‐controlled, dose‐ranging study of belimumab in patients with active systemic lupus erythematosusArthritis Care & Research, 2009
- Phase 1/2 Double-Blind, Placebo-Controlled, Dose Escalation, Safety, and Pharmacokinetic Study of Pagibaximab (BSYX-A110), an Antistaphylococcal Monoclonal Antibody for the Prevention of Staphylococcal Bloodstream Infections, in Very-Low-Birth-Weight NeonatesAntimicrobial Agents and Chemotherapy, 2009
- Treatment of patients with new onset Type 1 diabetes with a single course of anti-CD3 mAb teplizumab preserves insulin production for up to 5 yearsClinical Immunology, 2009
- The role of B lymphocyte stimulator (BLyS) in systemic lupus erythematosusJCI Insight, 2009
- The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti–HER-2 Therapy and Personalized MedicineThe Oncologist, 2009
- The antibody zalutumumab inhibits epidermal growth factor receptor signaling by limiting intra- and intermolecular flexibilityProceedings of the National Academy of Sciences, 2008
- A pilot study: 131I-Antitenascin monoclonal antibody 81c6 to deliver a 44-Gy resection cavity boostNeuro-Oncology, 2008
- Prognostic Factors Related to Clinical Response in Patients with Metastatic Melanoma Treated by CTL-Associated Antigen-4 BlockadeClinical Cancer Research, 2007
- A phase Ib study of pertuzumab, a recombinant humanised antibody to HER2, and docetaxel in patients with advanced solid tumoursBritish Journal of Cancer, 2007