Immunomedics announced that it has received notices that the U.S. and Australian patent offices have allowed claims in respective patent applications covering methods for treating a wide range of autoimmune diseases using monoclonal antibodies that bind to the CD22 antigen present on B-lymphocytes.
The allowed claims cover the use of the Company's lead product, epratuzumab, which is a humanized anti-CD22 monoclonal antibody.
The claims also cover the use of anti-CD22 antibodies, alone and in combination with other therapeutics, including antibodies, cytokines, or drugs, for the treatment of major autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, vasculitis, multiple sclerosis, myasthenia gravis, diabetes mellitus, and ulcerative colitis. The Company already has received patents for the use of CD22 antibodies in the therapy of B-cell lymphomas.
"Gaining this patent protection in these two countries will further strengthen the proprietary position of our CD22 antibody, epratuzumab, as we advance its development for the treatment of autoimmune diseases such as lupus and Sjogren's syndrome, which are in clinical trials," commented Company President and CEO, Cynthia L. Sullivan.
Epratuzumab is a humanized monoclonal antibody that targets CD22 antigen, found on the surface of B-lymphocytes, a type of white blood cell. Epratuzumab is being evaluated in patients with Sjogren's syndrome and is also Immunomedics' lead product candidate in two pivotal Phase III trials for the treatment of patients with moderate and severe systemic lupus erythematosus (SLE). The FDA granted a Fast Track designation to the clinical development program for epratuzumab for the treatment of patients with SLE. Epratuzumab has also demonstrated good safety, tolerability, and clinical efficacy in more than 340 patients with non-Hodgkin's lymphoma, resulting in reports published in The Journal of Clinical Oncology and Clinical Cancer Research.