Northwest Biotherapeutics, Inc. · OTC:NWBO
Northwest Biotherapeutics — 2nd Immunotherapy of Cancer Conference (ITOC-2) 2015
15 slides from Northwest Biotherapeutics's conference presentation, Mar 30, 2015
Slide 1: Autologous Dendritic Cell Therapy for Cancer
Autologous Dendritic Cell Therapy for Cancer 2 nd Immunotherapy of Cancer Conference, ITOC - 2 Munich, Germany March 26, 2015 Marnix L. Bosch, MBA, PhD Chief Technical Officer Northwest Biotherapeutics
Slide 2: Disclaimer
Disclaimer Certain statements made in this presentation are “forward - looking statements” of NW Bio as defined by the Securities and Exchange Commission (“SEC”). All statements, other than statements of historical fact, included in this presentation that address activities, events or developments t
Slide 3: Glioblastoma Multiforme (GBM)
Glioblastoma Multiforme (GBM) • GBM, Stage IV glioma, presents a significant unmet medical need – Average time to recurrence approximately 7 months – Average time to death approximately 15 months • Standard of care, radiation therapy + temozolomide, was approved in 2005 for GBM • There is no life -
Slide 4: GBM – Standard Treatment and Progression
GBM – Standard Treatment and Progression 1. If possible, surgical removal of most of the tumor tissue 2. Chemo - radiation: six weeks of radiation therapy + concomitant temozolomide 3. Adjuvant temozolomide: ≥ 6 cycles of 5 days on, 23 days off 4. Following recurrence 1. NovoTTF device 2. BCNU/CCNU
Slide 5: DCVax-L: Introduction
DCVax - L: Introduction • DCVax - L is autologous dendritic cells (DC) pulsed with autologous tumor cell lysate – DC are the master cells of the immune system, and are required to induce an adaptive immune response – Tumor lysate provides the antigens against which the immune response will be direct
Slide 6: DCVax-L Phase I/II Trials for Newly Diagnosed GBM
DCVax - L Phase I/II Trials for Newly Diagnosed GBM • 20 newly diagnosed GBM; 14 recurrent GBM; 5 lower grade gliomas • Standard of care (surgery & 6 weeks radiation & chemo) + DCVax - L • Primary endpoint: safety; Secondary endpoint: p rogression f ree survival 6 Standard of Care* Matched Concurren
Slide 7: International Phase III Trial With DCVax-L for GBM
7 International Phase III Trial With DCVax - L for GBM • 348 patient , randomized (2:1), double blind, placebo controlled Phase III trial ▪ Primary endpoint: PFS (progression free survival ) ▪ Secondary endpoints include OS (overall survival ) ▪ 3 DCVax - L treatments upfront (Day 0, 10, 20), then 3
Slide 8: Informational Arm open label, for patients with apparent PD post chemo-radiation
Informational Arm open label, for patients with apparent PD post chemo - radiation 8 51 patients had evidence of apparent disease progression in imaging at Baseline Visit following 6 weeks’ chemo - radiation Patients re - imaged at Month 2 after Baseline Visit to confirm either actual disease progre
Slide 9: Informational Arm: Overall Results
Informational Arm: Overall Results • Median overall survival for the 51 patients with evidence of disease progression post chemo - radiation = 18.3 months (range 6.7 to >40.7 months) – This compares favorably to 14.6 months mOS for newly diagnosed GBM patients receiving standard care • 15 of 51 pati
Slide 10: Rapid Progressors: Results
Rapid Progressors: Results • 20 patients are classified as rapid progressors based on progression on 2 consecutive scans • Literature data show expected survival times of 8 – 10 months for such patients • Median survival in rapid progressors in the DCVax - L Informational Arm is 15.3 months (range 6
Slide 11: Recurrent GBM Median OS 8.3–10.8 Months In Literature
0 5 10 15 20 25 30 35 40 Recurrent GBM Median OS 8.3 – 10.8 Months In Literature 20 Patients Months 20 Rapid - Progressor Patients : Median Overall Survival 15.3 Months (Data as of February 2015) Patients Still Alive Patients Still Alive
Slide 12: Other Patients: Results
Other Patients: Results • 25 Informational Arm patients classified as Indeterminate : i.e., they had stable disease, or modest progression/regression, or unclear measurements – mOS = 21.5 months – 9 patients are still alive, at 26.9 – 40.7 months • 1 Informational Arm patient classified as a Pseudo
Slide 13: Indeterminate Patients: Median Overall Survival 21.5 Months
25 Indeterminate Patients: Median Overall Survival 21.5 Months (Data as of February 2015) 0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0 45.0 Months 25 Patients Patients Still Alive Std of Care for New GBM: 14.6 Months mOS N Engl J Med 352: 987 - 96 , 2005
Slide 14: Pseudo-Progressor Patient Overall Survival To Date
0 5 10 15 20 25 30 35 5 Patients 1 Pseudo - Progressor Patient Overall Survival To Date 30 Months (Data as of February 2015) 0 5 10 15 20 25 30 35 Months 1 Patient Patients Still Alive 5 Patients Unclassified Due to Lack of Follow - Up Images (Data as of February 2015) Informational Arm: Other Patie
Slide 15: Conclusions
Conclusions • Patients with evidence of disease recurrence immediately following 6 weeks of daily radiotherapy and chemotherapy after surgical resection of their brain tumors appear to survive longer than would be expected based on data in the literature, when treated with DCVax - L. • The apparent
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