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GEN News Highlights : May 18, 2011

Northwest Biotherapeutics Signs on Fraunhofer IZI for Brain Cancer Vaccine Development

Institute will manufacture DCVax-L for Phase III trials and compassionate use.

Northwest Biotherapeutics (NWBT) has contracted out the manufacturing of DCVax®-L immunotherapy for brain cancer as well as the management of European clinical trials and compassionate use of the drug to the Fraunhofer Institute for Cell Therapy and Immunology (IZI).

The company says Fraunhofer IZI has dedicated “a substantial portion” of its manufacturing facilities to producing DCVax-L. It has also selected and initiated contacts with clinical centers on behalf of NWBT. NWBT is eligible for certain grants through the German government which, if approved, can amount to as much as €2 million to €3 million ($2.8 million to 4.2 million).

DCVax combines a patient’s own dendritic cells with cancer antigens, with the aim of inducing immune responses against a patient’s cancer cells. In the U.S., the company has received clearance from the FDA for a 612-patient Phase III trial in prostate cancer and clearance from the FDA for Phase I trials in five other cancers.

DCVax is also the subject of a clinical trial for which NWBT earlier this month said it is actively recruiting and screening to enroll additional new patients. The ongoing 240-patient randomized, double-blind, placebo-controlled clinical trial is designed to examine the immunotherapy in glioblastoma multiforme. DCVax has also been tested in a Phase I/II trial for recurrent metastatic ovarian cancer.