Vaccinogen Announces Successful Acquisition of cGMP Manufacturing Facility
Nov 4, 2007
Frederick, MD, USA – November 4, 2007 – Vaccinogen announced today the successful acquisition of the cGMP manufacturing facility formerly owned by PerImmune BV a wholly owned subsidiary of Intracel Resources, LLC. Located In Emmen, The Netherlands, this facility has been built over the course of 3 years and has successfully obtained approvals by the Dutch and Swiss health authorities for the commercial manufacturing of OncoVAX® Active Specific Immunotherapy and by the US FDA for clinical trial purposes.
The Emmen facility is expected to be operational with trained specialists in 2008.
Founded by Michael G. Hanna, Jr., Ph.D., The purpose of Vaccinogen is to focus on the development of immunotherapy products for the treatment of solid tumors and on the commercialization of autologous tumor vaccine products.
OncoVAX® is based on a platform that utilizes an autologous (patient’s own) cancer cells as an active specific immunotherapy (ASI) for adjuvant treatment of colon cancer following surgery. The vaccine comprises sterile, metabolically active, irradiated, non-tumorigenic autologous tumor cells, with or without fresh frozen BCG bacteria as an adjuvant. OncoVAX® is produced individually for each patient and is administered by four intradermal injections. The vaccine is prepared using a proprietary, sterile manufacturing process following surgical removal of the colon tumor.
OncoVAX® immunotherapy is based on a decades-long attempt by scientists to transform the body’s immune response and its long-term memory to prevent the return of the disease. Such an approach has already been successful in preventing a number of infectious diseases. In most cases immune stimulation creates a population of white blood cells that can kill tumor cells wherever they arise in the body, years after surgical removal of the original tumor.
Vaccinogen’s scientists prepare a vaccine from the patient’s own tumor. The cells are dissociated, irradiated to make them non-tumorigenic and administered to the patient by three weekly injections, starting four weeks after surgery. A booster vaccination is administered six months later.
Vaccinogen is a biopharmaceutical company developing and commercializing cancer vaccines and other immunotherapeutic products. Based in Frederick, MD, the company has a portfolio of product candidates for the treatment of cancer, infectious disease, autoimmune and anti-inflammatory diseases and fully human monoclonal antibodies in various stages of clinical development. The company maintains a European subsidiary in Emmen, The Netherlands that operates a fully functioning cGMP manufacturing center for the production of OncoVAX® vaccine.