Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Mateon Therapeutics — Technical Presentation (November 2019)
17 slides from Oncotelic Therapeutics's technical presentation, Nov 25, 2019
Slide 1: Treatment of R/R anaplastic astrocytoma with anti-TGFB2 RNA therapeutic
Treatment of recurrent/refractory (R/R) anaplastic astrocytoma (AA, WHO grade 3) patients with anti-TGFB2 RNA therapeutic OT-101 vs. TMZ is associated with improved overall survival (ABSTRACT # ATIM-06) Fatih M. Uckun, Sanjive Qazi, David Nam, Larn Hwang, Vuong N. Trieu ONCOTELIC / MATEON THERAPEUTI
Slide 2: Disclosures
DISCLOSURES Drs. Fatih Uckun, Vuong Trieu, and Larn Hwang are employees and shareholders of Oncotelic, the sponsor for clinical development of OT101/Trabedersen (AP 12009) Drs Trieu and Hwang are listed as inventors on patents and patent applications related to OT101/Trabedersen (AP12009) Dr. Sanjiv
Slide 3: Acknowledgments
ACKNOWLEDGMENTS This clinical study NCT00431561(G004) was conducted in three centers in Austria, one center in Georgia, eight centers in Germany, six centers in India, two centers in Israel and nine centers in Russia. We thank the participating investigators, including: e Drs. U. Bogdahn, M. Mehdorn
Slide 4: OT101 (Trabedersen/AP12009) and Its Clinical Development
OT101 (Trabedersen/AP12009) and Its Clinical Development TGFB2-specific synthetic 18-mer phosphorothioate antisense oligodeoxynucleotide (S-ODN with FDA Orphan Drug (ODD) and Pediatric Rare Disease Designations (PRDD) Reduces TGFB2 production/secretion, inhibits proliferation as well as invasive mig
Slide 5: Post-hoc Analysis of OT101 Single Agent Activity in R/R HGG
Post-hoc Analysis of OT101 Single Agent Activity in R/R HGG: Waterfall Plot of Maximum Tumor Reductions of the 26-patient Favorable Response Population (CR:3, PR:16, SD>6 months:7) Median T,, = 11.7 months 0 25 | AA j™cam -50- CR APR 15: @ SD 26months -100 Maximum % Reduction Relative to Baseline
Slide 6: Swimmer Plot of Best Overall Responses, Favorable Response Population
203302 301525 310510 405704 404705 404702 107102 301524 305503 404417 403408 408412 309838 306545 102149, 405402 403405 407409 405413 404435 108138 304532 502201 404408 102141 308539 | a ¢ ¢ + Median PFS: 1109 days Favorable responses in both GBM and AA (GBM: 10 of 26 [38.5%], AA: 16 of 26 [61.5%])
Slide 7: Proportion Surviving Progression-Free
Proportion Surviving Progression-Free Favorable Response (CR, PR or SD26 months) to OT101 Single Agent Therapy is Associated with Improved PFS and OS in R/R High-Grade Glioma 8 8 0.75: 0.50: 0.25: ° 3 3 1.00: “i... Favorable responders (N=26) ‘7 Median OS = 1280d ple Allpatients (N=89) | 5 Median OS
Slide 8: Post-hoc Analysis of RR AA (WHO Grade 3) Patients Treated on Phase II Study
Post-hoc Analysis of RR AA (WHO Grade 3) Patients Treated on NCT00431561 Phase II Study OT101 OT101 Treatment group 2.5mg/cycle 19.8mg/cycle Combined Total N N N Patient population Intent-to-Treat (ITT) 14 16 30 Discontinued after randomization (before catheter-port surgery in 2 1 3 OT101 groups) Sa
Slide 9: OT101 Single Agent Activity in R/R AA (WHO Grade 3)
OT101 Single Agent Activity in R/R AA (WHO Grade 3): Patient Information and Objective Responses 0T101 (N=27) TMZ (N=11) OT101 (N=27) TMZ (N=11) Gender -# (%) Number of Chemotherapy Cycles Female 8 (29.6) 4 (36.4) Median (Range) NA 6 (1-6) NA Male 19 (70.4) 7 (63.6) NS Mean + SE NA 51405 Race - # (%
Slide 10: Overall Survival Outcome of R/R AA (WHO Grade 3)
Overall Survival Outcome of R/R AA (WHO Grade 3) Patients Treated with OT101 vs. TMZ 1.00: 27 AA patients treated with OT101 (Median OS = 1136d) 0.75 0.50 Proportion Patients Surviving © & etal *) 11 TMZ patients treated | i a a | (Median OS = 590d) ooo} P=0.011 | 0 250 = 500 750 «1000 1250 1500 175
Slide 11: Conclusions
CONCLUSIONS Proof of concept: It is feasible to administer immuno-oncology drugs via extended intratumoral application/CED for up to 5 months Anti-TGFB2 RNA therapeutic OT101 appears to exhibit clinically meaningful single-agent activity against HGG in the absence of other anti-cancer drugs or radia
Slide 12: Cautionary Statements
CAUTIONARY STATEMENTS Results should be interpreted with due caution due to the inherent limitations of a post-hoc analysis The HGG patient population was both small and heterogeneous; Pre- study progression was not centrally evaluated Genomic biomarkers were not collected; best overall response ass
Slide 13: Backup Slides
Backup Slides
Slide 14: Infusion
Infusion Pump In-line Filter Internal / Implanted Components
Slide 15: Post-hoc Analysis of RR HGG (WHO Grade AA and GBM)
Post-hoc Analysis of RR HGG (WHO Grade 3 AA and WHO Grade 4 GBM) Patients Treated on NCT00431561 Phase II Study OT101 OT101 Treatment group 2.5mg/cycle 19.8mg/cycle Combined Total N(AA/GBM) N(AA/GBM) N(AA/GBM) Patient population Intent-to-Treat (ITT) 48 (14/34) 50 (16/34) 98 (30/68) aries roupsy ran
Slide 16: Univariate and Multivariate Analysis of PFS and OS Outcome
Univariate and Multivariate Analysis of PFS and OS Outcome According to Risk Factor 2 Risk Factor PFS (Days) ¢ P-Value Z-stat / OS (Days) x P-Value Z-stat / Median (95% Cl) P-value Median (95% Cl) P-value Diagnosis GBM (N=62) 38 (35-61) 17.5 0.00003 2.4/0.018 274 (180-399) 16.1 0.00006 2.0/0.04 AA (
Slide 17: Univariate and Multivariate Analysis of PFS and OS Outcome
Univariate and Multivariate Analysis of PFS and OS Outcome According to Risk Factor 2 Risk Factor PFS (Days) x P-Value Z-stat / OS (Days) x P-Value Z-stat / Median (95% Cl) P-value Median (95% Cl) P-value Total OT101 Dose (mg/m?) 1.1-14 (N=30) 36 (35-60) 2 0.16 2.7/0.006 222 (152-406) 3:5) 0.06 2.3/
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