NW Bio Offers 'Promising Survival Data' in 51 GBM Patients Treated with DCVAX-L: Data Demonstrated Substantially Longer-Than-Expected Survival

Northwest Biotherapeutics, Inc.

("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for cancer, announced today that Dr. Marnix Bosch, the Company's Chief Technical Officer, presented encouraging survival data on 51 Glioblastoma multiforme (GBM) brain cancer patients treated with DCVax®-L. The data showed substantially longer than expected survival in patients with apparent early progression (recurrence) of their cancer, including patients with such aggressive cancer that the tumor was already re-growing by the end of 6 weeks of daily radiotherapy and chemotherapy after surgical removal of the original tumor. Northwest Biotherapeutics Logo. As previously announced, Dr. Bosch's presentation was made at the 2^nd Immunotherapy of Cancer (ITOC) Conference in Munich, Germany, yesterday and was webcast. The webcast of the presentation, entitled "Prolonged Survival In Patients With Recurrent GBM Who Are Treated With Tumor Lysate-Pulsed Autologous Dendritic Cells," can be seen for up to 30 days at http://nwbio.com/webcasts/ The presentation poster can be found on the Company's website. The 51 GBM patients were treated in an Information Arm outside the Company's Phase III clinical trial because they were not eligible for the trial, due to evidence of early tumor re-growth following 6 weeks of daily radiotherapy and chemotherapy which are standard of care. Overall Survival data is available for all 51 patients; however, MRI images are only available for 46 of the 51 patients. These 46 patients were classified by an independent medical imaging company into 3 groups, as follows. The other 5 patients remained unclassified, due to lack of available images. o 20 Rapid-Progressor Patients: Patients with a new lesion ≥ 1 cm. in size, or tumor growth of ≥25% both at a Baseline Visit and at Month 2 thereafter; o 25 Indeterminate Patients: Patients with evidence of progression at the Baseline Visit (rendering them ineligible for the trial), followed by stable disease, modest progression and/or modest regression (or unclear tumor measurements), neither of which is enough to classify them as either a Rapid-Progressor or a Pseudo-Progressor; o 1 Pseudo-Progressor: A patient whose Month 2 image showed resolution of most of the prior appearance of tumor growth that had been seen at the Baseline Visit. The prognosis for Rapid Progressor patients is especially poor: their median Overall Survival is only about 8 to 10 months, according to published scientific literature, and they generally are not expected to respond much to any treatments. There is no established benchmark for Overall Survival of the Indeterminate Patients, however, they can be compared to the general population of GBM patients, for whom median Overall Survival is 14.6 months. The survival to date, for each of these groups of Information Arm patients treated with DCVax-L, is as follows: o Overall: The median OS of the group of 51 Information Arm patients as a whole is 18.3 months. About 30% of the patients (15 of the 51) lived beyond 2 years, and most of these patients (12 of the 15) remain alive. o 20 Rapid-Progressors: The median OS among these 20 DCVax-L treated patients is 15.3 months (with patients surviving as long as 37.1 months), compared to expected median OS of 8.3 - 10.8 months with existing treatments, based on published literature on comparable patient populations -- a 50% improvement over the expected survival time. Further, one-third of these patients (7 of the 20) lived beyond 18 months – a doubling of the expected survival time with existing treatments. o 25 Indeterminate Patients: The median OS among these DCVax-L treated patients is 21.5 months (with patients surviving as long as 40.7 months), compared to median OS in the general population of newly diagnosed GBM patients of 14.6 months – a 50% improvement over the expected survival time. Further, 9 of these 25 patients remain alive today at more than 24 months, 6 of these 9 patients have exceeded 30 months, and 4 of these 9 patients have reached 35-40+ months. o 1 Pseudo-Progressor: This patient is still alive, with OS of 30.1 months to date. o 5 Unclassified Patients: The median OS is 9.2 months (with patients surviving as long as 30.1 months). As reflected in these data, both Rapid-Progressor Patients and Indeterminate Patients (as well as the Pseudo-Progressor Patient) treated with DCVax-L in the Company's Information Arm are surviving substantially longer than would be expected based on clinical experience reported in the literature. DCVax-L also continues to show an excellent safety profile, with no serious adverse events observed in these Information Arm patients. "We are quite encouraged to see survival times in our DCVax-L treated Information Arm patients that exceed the expected survival times with existing treatments by 50% or more," commented Linda Powers, CEO of NW Bio. "This survival data, which has been collected by the independent CRO managing our Phase III trial, provides an encouraging insight into the potential results of the DCVax-L treatments for newly diagnosed patients in the Phase III trial. The survival data also reinforce the results we have seen with extended survival in our prior Phase I/II trials, and reinforce NW Bio's position as a leader in immune therapies for cancer."