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CancerVax seeks approval to advance anticancer drug into clinic

CancerVax Corporation has filed an investigational new drug application with the FDA seeking permission to move its anticancer drug D93 into clinical development.

D93 is an investigatory, humanized, monoclonal antibody with a novel anti-angiogenic and tumor inhibitory mechanism of action. Preclinical studies with the compound have demonstrated its ability to reduce angiogenesis and inhibit tumor growth in in vivo models of several types of cancer.

“Filing an IND for our D93 antibody is an important milestone for CancerVax and should strengthen the pipeline of antibody-based product candidates that would be created through the pending merger of CancerVax and Micromet,” said David Hale, president and CEO of CancerVax. “We anticipate that, following FDA approval of the IND, we will initiate a phase I clinical trial of D93 later this year to evaluate its safety and tolerability in the treatment of patients with solid tumors.”

D93’s mechanism of action differs from other angiogenesis inhibitors that are being evaluated in clinical trials or that have been approved by the FDA, such as Avastin.

According to the company, D93 selectively binds to targets in the extracellular matrix, a molecular network that provides structural support to tissues and regulates cellular processes such as adhesion, migration and cell growth. These targets are exposed during tumor formation, when the collagen comprising the extracellular matrix is denatured or remodeled by tumor cells.