Veltuzumab is a humanized monoclonal antibody targeting CD20 receptors on B lymphocytes currently under development for the treatment of NHL and autoimmune diseases.
In autoimmune diseases, we are studying the subcutaneous formulation of veltuzumab in patients with immune thrombocytopenia (ITP), in a Phase 1/2 trial. This trial, designed to evaluate different dosing schedules, has completed patient accrual and patients are being followed for up to 5 years. On July 28, 2015 the Office of Orphan Products Development of FDA granted orphan status for the use of veltuzumab for the treatment of ITP.
In oncology, a NCI-funded Phase 1/2 study in patients with aggressive NHL in combination with 90Y-epratuzumab tetraxetan has completed patient enrollment, with patient follow-up continuing.
We are currently evaluating various options for further clinical development of veltuzumab in ITP and other autoimmune disease indications, including pemphigus, as well as in oncology, including licensing arrangements and collaborations with outside study groups.
The Phase I/II trial in adult patients with chronic ITP has completed patient enrollment. For more information on this clinical trial, please go to clinicaltrials.gov.
The National Cancer Institute is funding a Phase I/II study combining veltuzumab with yttrium-90-labeled epratuzumab in patients with relapsed or refractory, aggressive NHL.
- Liebman H, Bussel JB, Saleh MN, Horne H, Wegener WA, Goldenberg DM. Comparison of two dosing schedules for subcutaneous injections of low-dose anti-CD20 veltuzumab in relapsed immune thrombocytopenia: final results of a phase I study. Blood 2013; 122(21): 1080.
- Liebman HA, Saleh MN, Bussel JB, Negrea OG., Horne H, Wegener WA, Goldenberg, DM. Low-dose anti-CD20 veltuzumab given intravenously or subcutaneously is active in relapsed immune thrombocytopenia: a phase I study. Br J Haematol. 162(5):693-701, Sept 2013.
- Tomblyn M, Witzig T, Himelstein A, Kio E, Sharkey RM, Rojo J, Wegener WM, Goldenberg DM. Anti-CD22 radioimmunotherapy (RIT) combined with anti-CD20 immunotherapy in aggressive non-Hodgkin lymphoma (NHL): Phase I results. Proc. Soc. Nucl. Med. 60th Annual Meeting, J. Nucl. Med. 54(Suppl 2): 304P (Abstr. #1368), 2013.
- Kalaycio M, Negrea OG, elstrom R, Farber C, Horne H, Wegener WA, Goldenberg DM. Monotherapy with subcutaneous (SC) injections of low doses of humanized anti-CD20 veltuzumab is active in chronic lymphocytic leukemia (CLL). Blood 2012; 120(21): 192.
- Negrea GO, Elstrom R, Allen SL, Rai KR, Abbasi RM, Farber CM, Teoh N, Horne H, Wegener WA, Goldenberg DM. Subcutaneous injections of low-dose veltuzumab (humanized anti-CD20 antibody) are safe and active in patients with indolent non-Hodgkin’s lymphoma. Haematologica 96(4):567-73, 2011.