Which are the antibodies to watch in 2013?

The start of the new year signals that it is time for mAbs’ annual review of the therapeutic monoclonal antibodies (mAbs) in active Phase 2/3 or Phase 3 clinical studies. The entire clinical pipeline currently includes ~350 mAbs, but most of these are in early development. As of the beginning of 2013, our “Antibodies to watch” list includes 28 single mAbs and one mAb mixture that are undergoing evaluation in Phase 3 studies for inflammatory or immunological disorders, cancers, high cholesterol, osteoporosis, Alzheimer disease and infectious disease. In alphabetical order, the 28 mabs are alirocumab, AMG 145, elotuzumab, epratuzumab, farletuzumab, gantenerumab, gevokizumab, inotuzumab ozogamicin, itolizumab, ixekizumab, lebrikizumab, mepolizumab, naptumomab estafenatox, necitumumab, nivolumab, obinutuzumab, ocrelizumab, onartuzumab, racotumomab, ramucirumab, reslizumab, romosozumab, sarilumab, secukinumab, sirukumab, solanezumab, tabalumab, and vedolizumab. The mixture of actoxumab and bezlotoxumab is being evaluated in two Phase 3 studies as a treatment for Clostridium difficile infection.

[1]  F. Raal,et al.  Low-Density Lipoprotein Cholesterol–Lowering Effects of AMG 145, a Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease in Patients With Heterozygous Familial Hypercholesterolemia: The Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterole , 2012, Circulation.

[2]  R. Giugliano,et al.  Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study , 2012, The Lancet.

[3]  S. Wasserman,et al.  Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study , 2012, The Lancet.

[4]  A. Shaywitz,et al.  Effects of AMG 145 on low-density lipoprotein cholesterol levels: results from 2 randomized, double-blind, placebo-controlled, ascending-dose phase 1 studies in healthy volunteers and hypercholesterolemic subjects on statins. , 2012, Journal of the American College of Cardiology.

[5]  E. Perez,et al.  5001 ORAL Trastuzumab Emtansine (T-DM1) Vs Trastuzumab Plus Docetaxel (H+T) in Previously-untreated HER2-positive Metastatic Breast Cancer (MBC): Primary Results of a Randomized, Multicenter, Open-label Phase II Study (TDM4450g/BO21976) , 2011 .