DCVax therapeutic cancer vaccine manufacturing process receives patent approval

Northwest Biotherapeutics, Inc. ("NWBT" or the "Company") (OTC Bulletin Board: NWBO) announced today that the US Patent and Trademark Office has allowed its patent application on a system for automation of the initial stages of the manufacture of the Company's DCVax® therapeutic cancer vaccines. These initial manufacturing stages are key to the very high concentration of dendritic cells (which are the critical ingredient) in the finished DCVax® vaccine.

The current first generation (non-automated) manufacturing is highly precise, and achieves a concentration of at least 80% or more dendritic cells in the vaccines. (In contrast, various immune therapy products being developed by other parties contain much lower levels of active ingredient.) The automation system covered by the US patent maintains NWBT's very high levels of dendritic cells, while also enabling major reductions in costs and scale-up to handle large numbers of patients.

The essential active component in the DCVax® vaccine is the patient's own master immune cells, called "dendritic cells." The dendritic cells are responsible for mobilizing the entire immune system, and its many players (including T cells, B cells and the antibodies they produce, natural killer cells and others). The dendritic cells are obtained through a blood draw from the patient, with the desired cells carefully separated from the many other types of cells in the patient's blood. The more rigorously and precisely the dendritic cells are isolated, the higher the concentration of this active ingredient in the vaccine.

The automated system developed by NWBT maintains this very high level of precision and purity of dendritic cells in DCVax®. After years of development work, the system is able to consistently and reliably separate the desired cells from the many other kinds of cells in a patient's blood, despite similarities among the cells and despite size differences of as little as a few microns. (By comparison, a human hair is around 50 microns in size.)

Use of NWBT's automated system has already been cleared by FDA for human clinical trials. The INDs (Investigational New Drug applications) which have been cleared by the FDA for five different cancers include use of the automated system in the manufacturing process for DCVax®.

Such automation of the initial stages of manufacturing DCVax® will greatly reduce the costs involved, including a more than 10-fold reduction in labor costs. For example, under current (first generation) processes, it takes 24 man hours to complete the initial manufacturing stage for 6 patients' vaccines. With the automated device, it takes only 2 man hours to complete the same work for 6 patients' vaccines. In addition, the need for certain high-cost materials is eliminated.

In addition to major reduction of direct costs, the automation also offers significant reduction of indirect costs: the reduction of capital costs for manufacturing facilities. Each manufacturing step that is "open" (i.e., in which the cells have any exposure to the air) must be carried out in "cGMP" clean room facilities where the air is sterile in the whole manufacturing suite. Such facilities are extremely costly to build, operate and maintain - so costly that the recoupment forms a large part of the costs of the vaccine. Automation can turn an "open" manufacturing step into a "closed" step, in which the cells remain enclosed in a machine or container, and have no exposure to the air. That eliminates the need for the air to be sterile, and enables those automated steps to be conducted in low-cost, ordinary space and facilities.

The automated system developed by NWBT, on which the US patent has now been allowed, makes just such a change: it turns the initial stages of DCVax® manufacturing into "closed" steps. Accordingly, a substantial portion of the high costs of sterile clean room facilities can be eliminated from the cost of producing DCVax®.

"We have spent over a decade working on manufacturing technologies to achieve cost efficiencies and scalability," said Dr. Marnix Bosch, Chief Technology Officer of NWBT. "NWBT has already achieved significant cost efficiencies by pioneering a unique batch manufacturing process. These efficiencies will be further enhanced by the automated system we have developed, and it is very gratifying to receive the allowance of this important US patent on our automated device."

The batch manufacturing process that NWBT has pioneered produces several years (typically at least 3 years) of personalized DCVax® vaccine for a patient in a single manufacturing run. The large, multi-year batch of the patient's vaccine is then frozen in single-dose vials and stored in standard bio freezers, making DCVax® an "off-the-shelf" product for that patient throughout the multi-year treatment period (and avoiding very costly repeat-cycles of manufacturing). The batch manufacturing process takes only 10 days. The shelf life and potency of the frozen DCVax® product have been validated.