Veltuzumab
Background
Veltuzumab is a humanized monoclonal antibody targeting CD20 receptors on B lymphocytes currently under development for the treatment of non-Hodgkin’s lymphoma (NHL) and autoimmune diseases.
We have licensed the subcutaneous formulation of Veltuzumab to Nycomed, GmbH, for all non-cancer indications worldwide, with rheumatoid arthritis as the primary indication. We retain the rights to Veltuzumab in cancer indications. In addition to initial cash and potential milestone payments, of which 3 have been received, the licensing agreement also provides us with an option to co-promote Veltuzumab for the immune thrombocytopenic purpura (ITP) indication in the United States.
We are studying the subcutaneous formulation of Veltuzumab in two Phase I/II trials. The first trial, for the treatment of ITP, is fully-funded by Nycomed. The second study is for the therapy of patients with chronic lymphocytic leukemia (CLL). In addition, a Phase I/II clinical trial, funded by a grant from the National Institutes of Health, is investigating the combination of Veltuzumab with yttrium-90-labeled Epratuzumab in patients with aggressive NHL.
Clinical Studies
Rheumatoid Arthritis
Nycomed has initiated a Phase II study of the subcutaneous formulation of Veltuzumab in patients with rheumatoid arthritis. More information can be accessed at clinicaltrials.gov.
Immune Thrombocytopenic Purpura (ITP)
Updated results from the Phase I/II trial in adult patients with chronic ITP who failed at least one standard therapy were presented at the 16th Congress of the European Hematology Association in 2011. For more information on this clinical trial, please go to clinicaltrials.gov.
Non-Hodgkin’s Lymphoma/Chronic Lymphocytic Leukemia
Results from the study in NHL have been published in Haematologica. Information on the Phase I/II trial in patients with CLL can be obtained from clinicaltrials.gov.
Aggressive Non-Hodgkin’s Lymphoma
The Phase I/II study combines Veltuzumab with yttrium-90-labeled Epratuzumab in patients with relapsed or refractory, aggressive non-Hodgkin's lymphoma clinicaltrials.gov.
References
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Subcutaneous injections of low-dose anti-CD20 Veltuzumab for patients with relapsed immune thrombocytopenia (ITP). A. Liebman, N. Saleh, J. Bussel, P. Bernstein, G. Negrea, C. Onyegbula, M. Farber, M. Bernhold, A. Horne, K. Teoh, A. Wegener, D. Goldenberg. Haematologica 96(s2):abstract 0527, 2011.
Subcutaneous injections of low-dose Veltuzumab (humanized anti-CD20 antibody) are safe and active in patients with indolent non-Hodgkin lymphoma. O.G. Negrea, R. Elstrom, S.L. Allen, K.R. Rai, R.M. Abbasi, C.M. Farber, N. Teoh, H. Horne, W.A. Wegener, D.M. Goldenberg. Haematologica 96:567-573, 2010.
Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. D.M. Goldenberg, F. Morschhauser, W.A. Wegener. Leuk Lymphoma 51:747-755, 2010.
Properties and structure-function relationships of Veltuzumab (hA20), a humanized anti-CD20 monoclonal antibody. D.M. Goldenberg, E.A. Rossi, R. Stein, T.M. Cardillo, M.S. Czuczman, F.J. Hernandez-Ilizaliturri, H.J. Hansen, C. Chang. Blood 113:1062-1070, 2009.
Humanized anti-CD20 antibody, Veltuzumab, in refractory or recurrent non-Hodgkin's lymphoma: Phase I/II results. F. Morschhauser, J.P. Leonard, L. Fayad, B. Coiffier, M. Petillon, M. Coleman, S.J. Schuster, M.J.S. Dyer, H. Horne, N. Teoh, W.A. Wegener, D.M. Goldenberg. J Clin Oncol 27:3346-3353, 2009.
