Northwest Biotherapeutics, Inc. · OTC:NWBO
Northwest Biotherapeutics — Phacilitate Conference 2019
26 slides from Northwest Biotherapeutics's conference presentation, Jan 23, 2019
Slide 1: DCVax-L Personalized Immune Therapies
DCVax®-L Personalized Immune Therapies Phacilitate Conference “The Next Breakthrough: Challenging the Status Quo” January 23, 2019
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 tha
Slide 3: Solid Tumors Remain A Challenge For Immunotherapies
Solid Tumors Remain A Challenge For Immunotherapies DCVax®-L Is Designed To Meet This Challenge 3
Slide 4: Key Challenge for Immune Therapies: Solid Tumors
Key Challenge for Immune Therapies: Solid Tumors Solid Tumors Comprise At Least 80% of All Cancers and Solid Tumors Are Highly Variable – A Personalized Disease • Extensive variations among cancers • Extensive variations among patients, even with “same” cancer • Significant variations within a singl
Slide 5: Scientific Knowledge Growing Rapidly, But Survival Improvements Limited In Many Solid Tumors
Scientific Knowledge Growing Rapidly, But Survival Improvements Limited In Many Solid Tumors Example: Glioblastoma brain cancer. Standard of care chemo approved in 2005 (to be added to surgery and radiation) based on adding 10 weeks of survival In the 14 years since then…. Ø extensive genomic and ep
Slide 6: 417 clinical trials for Glioblastoma, 31,952 patients, only 16 Phase 3
• 417 clinical trials for Glioblastoma 2005-2016 • 31,952 patients • only 16 Phase 3 trials – only 1 Phase 3 trial positive result 6
Slide 7: Cancer Therapies Have Tended to Search for Silver Bullets
Cancer Therapies Have Tended to Search for “Silver Bullets” Cancer therapies typically 1 active agent (“silver bullet” agent) aimed at 1 or couple of targets (“silver bullet” target) • CAR-Ts, TCRs • Peptides • Checkpoint inhibitors • Antibodies • Targeted therapies Some therapies in early developme
Slide 8: How Realistic Are Silver Bullets Against Complexity and Heterogeneity?
How Realistic Are “Silver Bullets” Against Enormous (and Dynamic) Complexity and Heterogeneity?? (examples of Cancer Genome Atlas Project findings…. initial publication on GBM in 2008) 8
Slide 9: How Realistic Are Silver Bullets Against Complexity and Heterogeneity?
How Realistic Are “Silver Bullets” Against Enormous (and Dynamic) Complexity and Heterogeneity?? (larger sample set in 2013 Cancer Genome Atlas Project publication) 9
Slide 10: How Realistic Are Silver Bullets Against Complexity and Heterogeneity?
How Realistic Are “Silver Bullets” Against Enormous (and Dynamic) Complexity and Heterogeneity?? (functional aspects -- factors helping to enable tumor escape) News Release Posted: October 28, 2013 Genomic Understanding of Glioblastoma Expanded Glioblastoma multiforme (GBM) was the first cancer type
Slide 11: DCVax-L Takes A Different Approach: Many Active Agents Against Many Targets
DCVax®-L Takes A Different Approach: Many Active Agents Against Many Tumor Targets The Opposite of “Silver Bullets” 11
Slide 12: Key Characteristics of DCVax-L
Key Characteristics of DCVax®-L 1. Uses master cell of immune system: dendritic cells Ø Mobilizes many active agents – whole immune system, both T cells and others. 2. Fully personalized Ø Avoids Russian roulette at the outset, as to whether patient’s tumor expresses the treatment target -- fits the
Slide 13: Dendritic Cells Mobilize Overall Immune System
Dendritic Cells Mobilize Overall Immune System DENDRITIC CELLS Signals activate & biomarkers “educate” the master Dendritic Cells immune cells INNATE IMMUNE SYSTEM ADAPTIVE IMMUNE SYSTEM “First-responders” (within hours/days) Follow-on defense (within week or weeks) Response is automatic Response is
Slide 14: Each Dendritic Cell Activates Hundreds of T Cells
Large Multiplier: Each Dendritic Cell Activates Hundreds of T Cells, Diverse T Cells and Others activated anti-cancer T cells travel to tumor site Dendritic Dendritic Cell Cell tumor target proteins anti-cancer T cell activated resting anti-cancer activated anti-cancer T cell attaches to DC T cells
Slide 15: T Cells Infiltrate Glioblastoma Tumors After DCVax-L
T Cells Infiltrate Glioblastoma Tumors After DCVax®-L Infiltration of T cells into Glioblastoma tumors is observed in patients treated with DCVax®-L Both CD4 and CD8 T cells are seen L. Liau et al. 15
Slide 16: Clinical Results To Date With the DCVax-L Approach Are Encouraging
Clinical Results To Date With the DCVax®-L Approach Are Encouraging 16
Slide 17: International Phase 3 Trial of DCVax-L Nearing Completion
International Phase 3 Trial of DCVax®-L for Newly Diagnosed Glioblastoma Is Nearing Completion • 331-patients in Intent to Treat (ITT) population (one of the largest late-stage trials of a cell therapy) • Over 80 sites in US, Canada, UK and Germany • Randomized 2:1 (SOC + DCVax®-L vs. SOC + placebo)
Slide 18: Blinded Interim Data From Phase 3 Trial Published & Presented
Blinded Interim Data From DCVax®-L Phase 3 Trial Published & Presented Initial (2017) blinded interim data published in JTM in May 2018. Updated (2018) blinded interim data presented in plenary session at Society for Neuro-Oncology in November 2018 18
Slide 19: Survival of Whole ITT Population, From Surgery
Survival of Whole ITT Population, From Surgery (interim data: 2018) Median OS Survival at Survival at Survival at Population n since surgery 1 year 2 years 3 years ITT 331 23.1 months 89.3% 46.4% 28.2% 19
Slide 20: Survival By Prognostic Factors, From Surgery
Survival By Prognostic Factors, From Surgery (interim data: 2018) Age Performance Status Extent of Surgery Lymphocyte Count 20
Slide 21: Survival By MGMT Methylation Status, From Surgery
Survival By MGMT Methylation Status, From Surgery (interim data: 2018) Median OS Survival at Survival at Survival at Data set n since surgery 1 year 2 years 3 years MGMT Methylated 131 35.1 months 94.6% 66.6% 49.1% MGMT Unmethylated 162 19.8 months 86.4% 32.6% 14.3% 21
Slide 22: Survival of Top 100 Patients, From Surgery
Survival of Top 100 Patients, From Surgery (interim data: 2017 & 2018) n KM- derived mOS 95% CI Top 30% (2017) 100 40.4 mos 35.5-46.5 Top 30% (2018) 100 58.4 mos 45.9-94.5 Extended survival not fully explained by known prognostic factors 22
Slide 23: Top 100 Patients: Demographics
Top 100 Patients: Demographics Prognostic Factor Top 100 ITT Age <50 + methylated MGMT + 8% 6% Complete resection Median age and range 56 (21, 70) 55 (19, 73) Age >65 years 16% 17% Age <50 years 28% 25% KPS median (range) 90 (50, 100) 90 (40, 100) KPS ≥80 95% 82% Methylated MGMT 66% 39% Complete res
Slide 24: Survival Findings: Key Points
Survival Findings: Key Points • Overall survival in the ITT population is longer than observed in historical and contemporary controls • This extended survival is observed both in patients with favorable prognostic factors and in patients with unfavorable prognostic factors – Age ≥50 years and Age <
Slide 25: The DCVax-L Approach is Practical for Commercialization And Amenable To Automation
The DCVax®-L Approach is Practical for Commercialization And Amenable To Automation 25
Slide 26: DCVax-L: Operationally Practical for Commercialization
DCVax®-L: Operationally Practical for Commercialization • Only 1 manufacturing run per patient • Frozen product (“off the shelf” doses); frozen shelf life validated • Amenable to automation • Simple administration to patient: intra-dermal injection • Compatible with Standard of Care and diverse expe
Northwest Biotherapeutics — Phacilitate Conference 2019 on 6ix