Alaunos Therapeutics, Inc. · NASDAQ:TCRT
Alaunos Therapeutics — Ziopharm Oncology — Corporate Update (November 2016)
18 slides from Alaunos Therapeutics's corporate update, Nov 17, 2016
Slide 1: ZIOPHARM Oncology Investor Update Call
ZIOPHARM Oncology Investor Update Call November 17, 2016 21st Annual Scientific Meeting of the Society for Neuro-Oncology 1
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains certain forward-looking information about ZIOPHARM Oncology, Inc. 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-looking sta
Slide 3: Addressing unmet medical needs: pipeline
Addressing unmet medical needs: pipeline Ad-RTS-IL-12 CAR CD19 2nd Gen. shortened manufacture CD19 3rd Gen. with mbIL15 CD33 Merck Target 1 Merck Target 2 Off-the-shelf NK Cells Primary NK cells Combination with Ad-RTS-IL-12 Genetically-engineered TCR Sleeping Beauty TCR Sleeping Beauty TCR and cyto
Slide 4: Controlled intra-tumor delivery of IL-12
Controlled intra-tumor delivery of IL-12 Ad-RTS-hIL-12 + veledimex IL-12 Ad injected intratumorally Oral ligand activates gene switch Localized production of IL-12 T-cell activation to tumor- associated antigens Influx of CD8+ T cells and reduction in CD4+ Tregs Pro-inflammatory cytokine can reverse
Slide 5: Ad-RTS-hIL-12 results in long-term remodeling of the tumor microenvironment
Ad-RTS-hIL-12 results in long-term remodeling of the tumor microenvironment Phase 1b/2 study of Ad-RTS-hIL-12 + veledimex following standard chemotherapy in locally advanced or metastatic breast cancer 5
Slide 6: Study of Ad-RTS-hIL-12 with veledimex in glioblastoma or malignant glioma
A study of Ad-RTS-hIL-12 with veledimex in subjects with glioblastoma or malignant glioma GBM affects approximately 74,000 people worldwide each year For multiple recurrence, median overall survival (OS) is 6 to 7 months OS in patients that have failed temozolomide and bevacizumab, or equivalent sal
Slide 7: Study population
Study population As of October 14, 2016, 17 subjects enrolled. Follow-up is ongoing. Ad-RTS-hIL-12 at 2x1011 viral particles 20 mg V Cohort 30 mg Cohort 40 mg Cohort Total (N=7)(N=4)(N=6)(N=17) Age in years Median-39.4-64.1-51.6-51.3 Gender Male : Female-4 : 3-2 : 2-4 : 2-10 : 7 Multiple Recurrences
Slide 8: RTS switch responds to presence/absence and dose of veledimex in GBM patients
RTS® switch responds to the presence/absence and dose of veledimex in GBM patients Tumor Level 40 30 20 10 150 100 50 IL-12 20 mg 30 mg 40 mg 20 mg 30 mg 40 mg 0 At Craniotomy 0 Baseline Maximum Post-treatment veledimex veledimex veledimex 150 Peak Plasma 200 IFN? 100 50 150 100 50 0 Cmax 0 Baseline
Slide 9: Overall survival
Overall survival Based on Kaplan-Meier plot, estimated median OS (mOS) is 12.8 months for all subjects, with 11 of 17 subjects alive, as well as for the 20 mg cohort Median PFS is 2.6 months All pseudo progression/progression/ pseudo-responses are assumed to trigger PD for PFS analysis at this time
Slide 10: Median overall survival relative to historical controls
Median overall survival (mOS) relative to historical controls Study & Design Treatment N Disease Median Age Median # Recurrence mOS (months) Survival rate % 6 months 9 months 12 months Ziopharm ATI001-102 Open-label Phase I Ad + V (Overall) 17 rGBM: 16 AA: 1 43 3 12.8 87 65 54 Ad+ V (20 mg) 7 rGBM:
Slide 11: Safety summary
Safety summary N=17, as of October 14, 2016 20 mg, N=7 30 mg, N=4 40 mg, N=6 Related ?Grade 3 TEAE 2 (29%) 2 (50%) 3 (50%) Related SAE 2 (29%) 1 (25%) 3 (50%) Dose discontinuation due to AE 1*(14%) 3 (75%) 4 (67%) Cytokine release syndromei– Grade 3 1 (14%) 1 (25%) 3 (50%) Frequency of drug-related
Slide 12: Overall survival in mouse GL-261 orthotopic supratentorial glioma model
Overall survival in mouse GL-261 orthotopic supratentorial glioma model Ad-RTS-mIL-12 + veledimex & anti PD-1 100 Vehicle/Vehicle 80 Ad+V 30 mg/m2 antiPD-1 15 mg/m2 2 2 60 Ad+V30 mg/m +antiPD-1 15 mg/m 40 20 0 0 10 20 30 40 50 60 70 80 90 Days Percent survival Data supports initiation of combining A
Slide 13: Overall survival in mouse GL-261 pontine glioma model
Overall survival in mouse GL-261 pontine glioma model Ad-RTS-mIL-12 + veledimex 100 Vehicle/Vehicle 80 Ad+V 10mg/m2 antiPD-1 15mg/m2 60 40 20 0 0 10 20 30 40 50 60 70 80 90 Days Percent Survival Data supports initiation of a pediatric brain tumor clinical trial during the first half of 2017 Ad-RTS-m
Slide 14: Conclusions and next steps
Conclusions and next steps Ad-RTS-hIL-12 + 20 mg veledimex is well tolerated and suggests a survival benefit over historical control at 6, 9 and 12 months Based on tolerability and survival benefit, 20 mg has been selected for an (ongoing) expansion cohort Toxicities were tolerable, predictable and
Slide 15: Corporate and financial highlights
Corporate and financial highlights Amended Exclusive Channel Collaborations with Intrexon o All unpartnered programs divided 80:20 in favor of ZIOPHARM – Provides greater reward for investing in development – Increases attractiveness to potential strategic partners o Sublicensed programs continue to
Slide 16: Upcoming programs and milestones
Intra-tumoral IL-12 RheoSwitch® programs o Initiate Phase 2/3 clinical trial for GBM in 2017 o Initiate combination study of Ad-RTS-hIL-12 + veledimex with immune checkpoint inhibitor therapy (PD-1) during the first half of 2017 o Initiate Phase 1 study in the treatment of brain tumors in children d
Slide 17: References
References i: Taal, W, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomised controlled phase 2 trial. Lancet Oncology, 2014, 15: 943–953. ii: Balmaceda C, et al. Multi-institutional phase I
Slide 18: ZIOPHARM Oncology Call
ZIOPHARM Oncology Investor Update Call November 17, 2016 21st Annual Scientific Meeting of the Society for Neuro-Oncology