Immunomedics, Inc., a clinical-stage biopharmaceutical company, develops monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. Clinical Programs The company focuses its activities on unlabeled, or ‘naked’ antibodies and antibodies conjugated with drugs, cytokines, or toxins, and on the use of radioisotopes, such as such as yttrium-90 (90Y). Antibody-Drug Conjugates (ADCs): The company has two product candidates from its proprietary ADC program that are in clinical development, focusing on the treatment of patients with metastatic solid tumors. The first ADC program, sacituzumab govitecan, is an anti-TROP-2-SN-38 ADC being evaluated in patients with various solid tumors. Labetuzumab govitecan is an anti-CEACAM5-SN-38 ADC that is in development for the treatment of metastatic colorectal cancer. Sacituzumab govitecan or IMMU-132: Sacituzumab govitecan is an ADC that contains SN-38, the active metabolite of irinotecan, approved by Health Authorities, including the U.S. Food and Drug Administration (FDA), as a chemotherapeutic for patients with cancer. Sacituzumab govitecan was created at the company by conjugating SN-38 site-specifically and at a high ratio of drug to hRS7, its anti-TROP-2 antibody. Sacituzumab govitecan has received Fast Track designation from FDA for the treatment of patients with TNBC who have failed prior therapies for metastatic disease and for patients with small-cell lung cancer (SCLC), or non-small-cell lung cancer (NSCLC). This ADC also has been designated an orphan drug by FDA for the treatment of patients with SCLC or pancreatic cancer in the U.S. and by the European Medicines Agency (EMA) for the treatment of patients with pancreatic cancer in the European Union. Labetuzumab Govitecan or IMMU-130: The company’s second investigational solid-tumor ADC involves its anti-CEACAN5 antibody, labetuzumab, conjugated to SN-38. The agent is being studied in patients with mCRC who had received at least one prior irinotecan-containing regimen and had an elevated blood titer of carcinoembryonic antigen (CEA). Epratuzumab: Epratuzumab is a humanized antibody which targets CD22, an antigen found on the surface of B lymphocytes, a type of white blood cell critical to proper immune system function. Early-Stage Programs The company has additional potential products for the treatment of cancer and autoimmune diseases, including veltuzumab, its anti-CD20 antibody, and milatuzumab, its anti-CD74 antibody. IMMU-114 IMMU-114 is a novel humanized antibody directed against an immune response target, HLA-DR, under development for the treatment of patients with B-cell cancers. Milatuzumab Milatuzumab is a humanized monoclonal antibody targeting tumors that express the CD74 antigen, which is present on various hematological tumors and even on some solid cancers, with restricted expression by normal tissues. It has received orphan drug designation from the FDA for the treatment of patients with chronic lymphocytic leukemia. Veltuzumab Veltuzumab is a humanized monoclonal antibody targeting CD20 receptors on B lymphocytes under development for the treatment of non-Hodgkin lymphoma (NHL) and autoimmune diseases. The company is evaluating various options for further clinical development of veltuzumab in immune thrombocytopenia and other autoimmune disease indications, as well as in oncology, including licensing arrangements and collaborations with outside study groups. Yttrium-90-Labeled Epratuzumab Tetraxetan 90Y-epratuzumab tetraxetan is the company’s radiolabeled anti-CD22 investigational product for patients with NHL or acute lymphoblastic leukemia (ALL). Diagnostic Imaging Products The company has continued to transition its focus away from the development and commercialization of new diagnostic imaging products in order to accelerate the development of its therapeutic product candidates, although the company continues to manufacture and commercialize LeukoScan (sulesomab) in territories where regulatory approvals have previously been granted. LeukoScan is indicated for diagnostic imaging to determine the location
immunomedics inc (IM3:Frankfurt)
300 The American Road
Morris Plains, NJ 07950
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