IDM Pharma, Inc. (NASDAQ:IDMI)
Industry: Healthcare
IDM Pharma Inc. (IDM), incorporated in 1987, is a biopharmaceutical company focused on developing products to treat and control cancer while maintaining the patient's quality of life. IDM is developing two lines of products designed to stimulate the patient's immune response. The Company's first line of product candidates, which are designed to destroy residual cancer cells, is based on in vivo or ex vivo activation of certain immune cells called macrophages. Its second line of product candidates designed to prevent tumor recurrence includes both synthetic and cell-based therapeutic cancer vaccines. On August 16, 2005, Epimmune Inc. completed a share exchange transaction with the shareholders of Immuno-Designed Molecules, S.A. and related transactions, referred to as the Combination. In connection with the closing of the Combination, Epimmune changed its name from Epimmune Inc. to IDM Pharma, Inc. Products to Destroy Residual Cancer Cells Junovan is an immune system stimulant that IDM is developing for the treatment of osteosarcoma, which is a rare aggressive bone tumor that occurs primarily in adolescents and young adults. Junovan activates macrophages in vivo, in order to enhance their ability to destroy cancer cells. A randomized Phase III study of Junovan in 793 patients for the treatment of newly diagnosed osteosarcoma in combination with a three or four drug chemotherapy regimen was conducted by Children's Oncology Group, under an investigational new drug application (IND) granted by the United States Food and Drug Administration (FDA) and held by the National Cancer Institute, prior to the Company's purchase of Junovan in 2003. Junovan is limited for clinical investigational use only; its safety and efficacy have not been reviewed or approved for commercial distribution by any regulatory agencies. IDM is preparing marketing authorization applications for submission in the United States and Europe, which the Company expects to submit in 2006. If IDM's applications are submitted as planned and are accepted by the respective agencies, and if it receives regulatory approval, the Company intend to start commercializing Junovan in 2007. Bexidem is a cell-based immunotherapeutic consisting of monocyte-derived activated killer cells (MAK cells) derived from the patient's own white blood cells. This cell drug is in development as an adjuvant treatment after transurethral resection (TUR), for patients with superficial bladder cancer. A Phase II/ III study of Bexidem for treatment of patients with superficial bladder cancer with intermediate to high risk of recurrence is in progress in France, Belgium, Luxembourg and Germany. In November 2005, IDM filed a Special Protocol Assessment (SPA), request for a second Phase II/ III clinical study of Bexidem planned in the United States in order to compare TUR associated with Bexidem to TUR alone in patients with recurrent superficial papillary bladder cancer who have failed intravesical Bacilli Calmette-Guerin therapy (BCG). Clearance to initiate the study is still subject to FDA's approval of complementary chemistry, manufacturing, and control (CMC), information to be provided with respect to Bexidem and its manufacturing process. Jenact is a second-generation compound derived from Junovan. Jenact is an immune system stimulant that can be administered orally or in a systemic fashion. Preclinical studies have shown that it has low toxicity and it has also shown efficacy in an animal model. Preclinical models also demonstrated a potential as an adjuvant, as well as anti-infectious activity. The Company intends to explore its use for treatment of cancers that are prone to lung or liver metastases, such as breast, digestive tract and renal cancers. Products to Prevent Tumor Recurrence Uvidem is a cell drug made from the patient's own cells and consists of dendritophages loaded with melanoma cell antigens using cell lines licensed to the Company by third parties. Uvidem is in Phase II clinical trials for the treatment of melanoma. Sanofi-Aventis has exercised an op
As Of: 10/07 00:00 ET
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