Ofatumumab is a novel, investigational, fully-human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells.4 This epitope is different from the binding sites targeted by other CD20 antibodies currently available.(5) The CD20 molecule is a key target in CLL therapy because it is highly expressed in most B-cell malignancies.(6) Ofatumumab is being developed under a co-development and commercialisation agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country. In Europe, ofatumumab has been granted orphan designation for CLL as it affects approximately 3.5 in 10,000 persons in the European Union.(8) About CLL
CLL is the most common adult leukaemia(1,2) and one of the most common malignant lymphoid diseases.(7) Based on 2007 worldwide estimates, leukaemia accounted for more than 330,000 new cases and more than 245,000 deaths.(9) GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For further information please visit www.gsk.com. GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary 'bench to bedside' approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centers. GSK is closing in on cancer from all sides with a new generation of patient-focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies. GSK's BioPharm R&D division has a rich early pipeline based on cutting edge molecular biology and genetic technology and a mature late-stage portfolio that will provide important medicines to oncology. Genmab A/S is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab's world class discovery, development and manufacturing teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit www.genmab.com. Arzerra™ is the proposed registered trademark to be used in the United States and Europe. References
1. American Cancer Society. Cancer Facts and Figures 2008. http://cancer.org/downloads/STT/2008CAFFfinalsecured.pdf. Accessed 28 January 2009
2. Eichhorst B. Chronic lymphocytic leukemia: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. Ann Oncol 2008. 19:60-62. doi:10.1093/annonc/mdn090.
3. Tam CS, O'Brien S, et al. The natural history of fludarabine-refractory chronic lymphocytic leukemia patients who fail alemtuzumab or have bulky lymphadenopathy. Leukemia and Lymphoma 2007;48(10):1931-1939
4. Hagenbeek A, Gadeberg O, et al. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood, 2008; 111: 5486-5495
5. Teeling JL, Mackus, W,J., et al. The Biological Activity of Human CD20 Monoclonal Antibodies Is Linked to Unique Epitopes on CD20. J Immunol 2006; 177: 362-371
6. Glennie MJ, French RR, et al. Mechanisms of killing by anti-CD20 monoclonal antibodies. Molecular Immunology, 2007;44 (16):3823-3837
7. Shanafelt TD, Byrd JC, et al. Narrative review: initial management of newly diagnosed, early-stage chronic lymphocytic leukemia. Ann Intern Med. 2006 Sep 19;145(6):435-47.
8. European Medicines Agency. Public Summary of Positive Opinion for Orphan Designation of Ofatumumab www.emea.europa.eu/pdfs/human/comp/opinion/48024408en.pdf Accessed 5 February 2009
9. American Cancer Society. Cancer Facts and Figures 2007. http://cancer.org/downloads/STT/Global_Facts_and_Figures_2007_rev2.pdf. Accessed 28 January 2009