BETHESDA, Md., \

March 5, 2013 Northwest Biotherapeutics  (NW Bio), a biotechnology company developing DCVax^® personalized immune therapies for solid tumor cancers, announced today that its Phase I/II  DCVax-Direct clinical trial for all inoperable solid tumor cancers is planned to begin within approximately the next sixty days.  As a Phase I/II trial, this trial is not blinded and the results will be seen as the trial proceeds.  With an efficacy endpoint of tumor regression (i.e., tumor shrinkage or elimination), this innovative trial is expected to yield meaningful ongoing results by the second half of 2013.

This clinical trial is approved by the FDA for all types of solid tumor cancers (i.e., cancers in any tissues of the body), and is configured to provide rapid results.  In the Phase I portion, it will test both safety and a variety of dosing regimes, and will do so in multiple different cancers – avoiding the need to conduct separate Phase I studies in each such cancer, as is usually the case.  Then, the trial will go directly into the Phase II portion, testing for efficacy, without the need for another FDA review.

DCVax^®

All immune responses start in the same way that involves initially a single cell type, the dendritic cell (DC). This cell functions like the General of an army, in that it directs all ensuing activities of the immune response. The immune system is like an army with many divisions, and multiple soldiers with various types of weapons. When an invader, which could be a virus, bacteria, or a cancer cell, encounters a DC the result is that the DC consumes or eats the invader and chops it into small pieces. In the process, the DC becomes activated and starts traveling to the lymph node. In the lymph nodes the DC elicits a cascade of events eventually involving the entire army that leads to a full-blown immune response. Importantly, the nature of the invader and the nature of the DC activation dictate the type of immune response: the DC is the general of the army who directs all the soldiers to work in synchrony, and who determines which weapons to use to best defeat the enemy. We believe that preparing the DC outside the body, as done for DCVax^® products, allows the greatest degree of control and begins the immune response in the natural fashion leading to the most complete attack on the foreign invader.

Different Approaches

We believe that the optimal way to arrive at the most effective immune response is through the control of the DC. Most traditional immunization approaches, including traditional virus, specific antigen or peptide vaccines as well as some that are used for immunotherapy of cancer, try to control the already existing DC in the body, or they try to modulate only one arm of the immune system. The immunogen, i.e. the virus, specific antigen, peptide or the cancer cells used to prepare the vaccine, is in those cases injected into the body in a formulation that aims at targeting and activating local DC. Examples are viral, specific antigen or peptide vaccines formulated with adjuvant, or killed tumor cells alone or modified to produce the DC mobilizing protein GM-CSF. In these instances, it is left to chance as to whether the immunogen arrives at the DC, whether the DC are properly activated, and effectively migrate to lymph nodes to produce an effective immune response. We believe that the failure of several recent clinical trials may be the result of the inability of these other approaches to effectively mount a natural and robust immune response.

Treatments that use only a single division of the immune system may employ only large amounts of T cells, or a single (monoclonal) antibody. DCVax^® products are being developed to activate all aspects of the immune response, both cellular and antibody, thus potentially providing a broader and longer lasting immune and clinical response. Northwest Biotherapeutics’ products are deigned as pure, activated DC loaded with the immunogen as would naturally occur, and that are capable of migrating to lymph nodes. The intended result is a very robust, and full immune response consisting of both a specific cellular T cell response and a specific antibody response against the cancer associated antigen. Data obtained in our Phase I and Phase II clinical trials suggest that such response may occur and may translate into a clinical benefit.

Cancer and the Immune System

Cancer cells produce many substances that shut down the immune response, as well as substances that paralyze the DC that are resident in the body. We believe therefore that the optimal time for controlling cancer growth by activating the immune system is at the time when tumor burden is low. Northwest Biotherapeutics targets patients with brain cancer following surgery, radiation and chemotherapy, and hormone independent prostate cancer patients with no detectable tumor growth. This approach aims at inducing powerful immune responses to control progression of the disease.

Manufacturing

Northwest Biotherapeutics has focused on solving many of the challenges that are typically associated with producing personalized products that consist of living cells. The Company’s new automated cell processing system allows high-throughput production of products for a fraction of the historical cost.

• DCVax^® products contain pure DC
• The DC in DCVax^® are prepared outside the body, which eliminates many uncontrollable variables, and are subjected to a potency test designed to ensure that the DC administered to the patient are capable of eliciting an immune response
• DCVax^® is used in patients with low tumor burden
• DCVax^® products can be manufactured in a cost-efficient manner