Alaunos Therapeutics, Inc. · NASDAQ:TCRT
Alaunos Therapeutics — ZIOPHARM Oncology — BioCentury Newsmakers (September 2013)
24 slides from Alaunos Therapeutics's conference presentation, Sep 27, 2013
Slide 1: The Future of Cancer Therapy
BioCentury Newsmakers Jonathan Lewis, MD, PhD Chief Executive Officer The Future of Cancer Therapy Exhibit 99.1 September 2013
Slide 2: Forward-Looking Statements
2 September 2013 Forward-Looking Statements This presentation contains certain forward-looking information about ZIOPHARM Oncology that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-
Slide 3: Clinical stage synthetic biology cancer company
3 September 2013 1. Clinical stage synthetic biology cancer company 2. We believe we are the farthest advanced at regulating gene function in vivo in humans, regulating gene expression, and titrating levels of expression 3. Lead clinical program is Ad-RTS-IL-12 4. We have multiple novel programs dri
Slide 4: DNA-Based Medicine Enables
4 September 2013 DNA-Based Medicine Enables • Therapies with desired biofunction to be purpose - built • The concentration/dose of biologic therapy to be precisely controlled • Improvement in therapeutic index, because potent biologic modifiers can be turned on and off and targeted to specific tissu
Slide 5: Foundation in Place for Significant Growth
5 September 2013 • Powerful, scalable technology platform • Potential for innovation in cancer-drug development: • ZIOP collaboration with Intrexon enables: – better control of therapeutic index/frequency – multigenic approaches – pipeline expansion with multiple INDs – attractive partnership opport
Slide 6: On Track to Execute
6 September 2013 • Clinical stage synthetic biology platform (DNA and cell-based therapy) driving development • Our advantage is that we are the farthest advanced at precisely regulating gene function in vivo in humans • Multiple value-creating milestones in 2013/14 – Pre-clinical/clinical data – Sc
Slide 7: Molecular and Cellular Oncology DNA-Coded Toolset
7 September 2013 Cells DC T Cell B Cell Macrophage NK cell Treg Other immune cells Direct tumor lysis ADCC Complement cytotoxicity Innate immunity stimulation Adaptive immunity stimulation Immune evasion inhibition Pro-apoptosis Necrosis Anti-angiogenesis Growth inhibition Anti-tumor metabolism EMT
Slide 8: Intrexon Collaboration: Fueling the IND Engine
8 September 2013 Intrexon Collaboration: Fueling the IND Engine Genetic control of cells Controlled delivery of therapeutic proteins cancer drug translational and development expertise Promising portfolio of cancer therapeutics gene engineering and cell control technology
Slide 9: Upcoming Milestones
Program Milestone Timing 2013-2014 9 September 2013 Upcoming Milestones IL-12 Phase 2 breast cancer study data 2H 2013/2014 Phase 2 advanced melanoma study data 2H 2013/2014 Initiate Phase 1/2 glioblastoma multiforme study Initiate Phase 2 melanoma combo study Initiate Phase 2 breast cancer combo st
Slide 10: The Potential of DNA-Based Therapeutics
10 September 2013 The Potential of DNA-Based Therapeutics • Improve treatment of all cancers, starting with breast cancer, melanoma, and GBM • Treat currently incurable cancers • Generate a multi-billion-dollar opportunity
Slide 11: A Growing Oncology Portfolio
Compound Pre Clinical Phase 1 Phase 2 11 September 2013 A Growing Oncology Portfolio IND Ad-RTS-IL-12 Melanoma Breast GBM Cell-based programs Cell signal targeting Multigenic platforms Immunotherapy Programs
Slide 12: Multiple Opportunities for External Partnering
12 September 2013 Multiple Opportunities for External Partnering Aggressive IND Strategy Supporting Future Growth
Slide 13: DNA-Based Therapeutics: RheoSwitch
13 September 2013 DNA-Based Therapeutics Controlled Delivery of Therapeutic Proteins with RheoSwitch®: This is the most advanced clinical method to turn genes on and off Dose-control Orally activated biologic on/off switch Local High Potency Monogenic/Multigenic Gene Expression RheoSwitch®
Slide 14: Initial Target: Interleukin-12, A Potent Cancer Therapeutic
14 September 2013 Initial Target: Interleukin-12, A Potent Cancer Therapeutic • Cytokine with anti-tumor effects • Potent Stimulation of T-cells and gamma interferon • Narrow therapeutic index/ toxicity has limited IL-12 utility Improved therapeutic index may be possible using RheoSwitch ® technolog
Slide 15: IL-12 Production is Modulated by Activator Ligand in HT 1080 Cells
15 September 2013 IL-12 Production is Modulated by Activator Ligand in HT 1080 Cells On Off On AL=75nM
Slide 16: Regulated expression of IL-12 in the tumor by switch control
16 September 2013 Regulated expression of IL-12 in the tumor by switch control Subjects received intratumoral injection of 1x10 viral particles (INXN-2001) on Day of each cycle and INXN-1001 (subject 107, 100 mg; subject 111, 160 mg) on Days 1-7 of each cycle. Genomic DNA and total RNA were extracte
Slide 17: Cytotoxic T Cells & Memory T Cells Increase in Tumor
17 September 2013 Cytotoxic T Cells & Memory T Cells Increase in Tumor following Treatment with Ad-RTS-hIL-12 Images were obtained using an Aperio ScanScope XT whole-slide imager and digitized at 20x. ASCO 2013 Screening C1D15 Subject (160 mg)
Slide 18: Prominent Inflammatory Response Correlates with High Levels of IFN
18 September 2013 Prominent Inflammatory Response Correlates with High levels of IFN- • Initial increase in lesion size due to inflammatory response seen at Cycle 1 Day 16 • Lesion was undetectable at Cycle 2 Day 1 • Subject ultimately progressed and was taken off study C2D1 C1D1 C1D16
Slide 19: Dose-dependent Anti-Tumor Activity in Murine 4T1 Breast Cancer Model
19 September 2013 Dose-dependent Anti-Tumor Activity of Ad-RTS-mIL-12 + Activator Ligand (AL) in Murine 4T1 Breast Cancer Model Time (Days) Vehicle Ad-RTS-mIL-12 INXN -1001 (AL) 15 mg/m2 Ad-RTS-mIL-12 + AL 15 mg/m2 Ad-RTS-mIL-12 + AL 30 mg/m2 Ad-RTS-mIL-12 + AL 75 mg/m2 Ad-RTS-mIL-12 + AL 150 mg/m2
Slide 20: Glioblastoma Multiforme: IL-12 Preclinical Activity
20 September 2013 Glioblastoma Multiforme: IL- 12 Preclinical Activity 100% survival observed with Ad-RTS-IL-12 + AL or DC-RTS-IL-12 + AL INXN-1001 dosing Day 4 to EOS at ~ 675 mg/m ² /day in chow; DC –RTS-IL12 or Ad-RTS-IL12 on Day 5 Kaplan Meier Survival in GL261 Orthotopic Syngeneic Mouse Glioma
Slide 21: Highlights of IL-12 Program
21 September 2013 Highlights of IL-12 Program • Currently demonstrating safety and efficacy in Phase 2 POC studies • Preparing for combination studies in melanoma, breast cancer • Expanding clinical program to GBM IL-12 program reaching key milestones in 2013/2014
Slide 22: Significant Market Potential for IL-12
22 September 2013 Incidence Melanoma 76,690 Breast Cancer 234,580 Glioblastoma 18,000 Significant Market Potential for IL-12 Source: American Cancer Society 2013/Schwartzbaum 2006
Slide 23: Clinical stage synthetic biology cancer company
23 September 2013 1. Clinical stage synthetic biology cancer company 2. We believe we are the farthest advanced at regulating gene function in vivo in humans, regulating gene expression, and titrating levels of expression 3. Lead clinical program is Ad-RTS-IL-12 4. We have multiple novel programs dr
Slide 24: The Future of Cancer Therapy
BioCentury Newsmakers Jonathan Lewis, MD, PhD Chief Executive Officer The Future of Cancer Therapy September 2013
ZIOPHARM Oncology — BioCentury Newsmakers (September 2013) on 6ix