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SAI-EGF

Amgen, Inc.

Drug Names(s): EGF Vaccine

Description: Dysregulation of the EGFR pathway is associated with the spread of tumors (metastases), decreased survival, and decreased effectiveness of chemotherapy and radiotherapy. Increased stimulation of the EGFR pathway may occur as a direct result of over-expression of EGFR, epidermal growth factor (EGF), or transforming growth factor-alpha (TGF-(alpha)). EGF and TGF-(alpha) are proteins that bind to and activate EGFR. Some cancerous cells secrete EGF and TGF-(alpha) which, in turn, fuel their growth and proliferation by increased activation of the EGFR pathway.

Specific active immunotherapy is an approach in which cells, cell fragments or proteins are utilized as antigens to stimulate the immune system. SAI-EGF stimulates the immune system to develop antibodies that specifically target EGF. In addition to developing antibodies, SAIs may elicit a T cell response. By recruiting the patient's own immune system, this approach may provide a multi-faceted immune response, resulting in broader activity at the target with corresponding biologic effects on tumor growth and proliferation.

Deal Structure: CancerVax and Tarcanta
CancerVax announced in July 2004 that its wholly owned subsidiaries, Tarcanta, Inc., and Tarcanta, Ltd. (Ireland), have obtained the exclusive rights to complete the clinical development of three specific active immunotherapeutic (SAI) product candidates that target the epidermal growth factor receptor (EGFR) signaling pathway for the treatment of cancer. Under the agreements, CancerVax rights include commercialization of successful product candidates within the U.S., Western Europe, Canada, Japan, Australia, New Zealand and Mexico.

Under the terms of the license agreements, CancerVax will provide upfront access fees, technology transfer fees, development and commercialization milestones and royalties upon commercial sales, if any. With the execution of these agreements, CancerVax is obligated to make access and technology transfer payments of approximately $6 million over the next three years. If the three product candidates are approved for...See full deal structure in Biomedtracker


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