Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Investor Presentation (January 2022)
16 slides from Oncotelic Therapeutics's investor presentation, Jan 26, 2022
Slide 1: A TGF-beta Company
A TGF-beta Company Anthony E. Maida, III, Ph.D., MA, MBA, BA, BA Chief Clinical Officer – Translational Medicine Oncotelic Therapeutics, Inc. 01/26/22 W W W. O N C O T E L I C . C O M
Slide 2: Management Team
Management Team • Vuong Trieu, PhD (CEO). Dr. Trieu, an expert in pharmaceutical development, currently serves as CEO/Chairman of Oncotelic Inc.. Previously he was President and CEO of Igdrasol- developer of 2nd generation Abraxane- Cynviloq. Igdrasol merged with Sorrento Therapeutics, he became CSO
Slide 3: Pipeline (Oncology and Virology)
Pipeline (Oncology and Virology) 3
Slide 4: OT-101/ Trabedersen
OT-101/ Trabedersen W W W. O N C O T E L I C . C O M 4
Slide 5: A Brief Review of TGF-β2
A Brief Review of TGF-β2 • A pleiotropic and promiscuous immune modulator • One of three (3) isomers, TGF-β1, TGF-β2 , TGF-β3 • A homodimeric cytokine 25kD that modulates, cell growth, differentiations, a potent immune suppressor, may act as a tumor promoter or tumor suppressor, induce EMT (epitheli
Slide 6: Antisense as Next Generation Drugs
Antisense as Next Generation Drugs Attributes Small Molecules mAb Antisense Inception 1850s to present 1920s to present 1990s to present Size 200-500 >150,000 5,000 to 7,000 Drug Discovery Random screening Focused screening Rationally designed Success Rate Low-~5% Moderate-~50% High-~90% Predictable
Slide 7: OT-101: Drug Product- TGF-β2 Antisense
OT-101: Drug Product- TGF-β2 Antisense. • Trabedersen (OT-101) is a single-stranded phosphorothioate antisense oligodeoxynucleotide (18-mer) targeting the human TGF-β2 messenger RNA • Ready for registration trials--Over 200 patients treated across 6 clinical trials • Strong Patent protection until 2
Slide 8: Clinical Efficacy: Glioblastoma
Clinical Efficacy: Glioblastoma Tr e a t m e n t f a i l u r e p a t i e n t s ( r e c a l c i t r a n t t o r a d i a t i o n , s u r g e r y , a n d c h e m o ) • Objective responses were observed among the 87 evaluable patients treated with OT-101: • Best Objective Responses were: 5 CR (5.9%), 14
Slide 9: Clinical Efficacy: Pancreatic Cancer
Clinical Efficacy: Pancreatic Cancer Phase 2- treatment failure pts/ recalcitrant to Whipple and chemo • Patient 1006: CR as far out as 77 mos • Patient 1022: OS of 40 months • Surgery: Whipple’s procedure • Surgery: Whipple’s procedure • 1st line: 5-FU/LV, Dose 425 mg/m2 • 1st line: Radiation thera
Slide 10: Clinical Efficacy: COVID
Clinical Efficacy: COVID • Large surge in TGF-beta during active COVID infection • An established role of TGF-beta in scarring and late stage post-COVID symptoms • Strong in vitro activity against SARS-COV-2 on Vero cells • OT-101 is in phase 2 clinical trial against COVID Oncotelic C001-2020-01 IM
Slide 11: Double-Blind Randomized Study of OT-101 in Hospitalized COVID-19 Subjects
A Double-Blind, Randomized, Placebo -Controlled, Multi-Center Study of OT- 101 in Hospit alized COVID -19 Subjects • Conducted in Peru and Argentina – 6 sites 3 in Peru and 3 in Argentina • 20 Part 1 Patients and 12 Part 2 Patients, 2:1 Randomization • Day 7 Mortality Rate of 4.5% vs 20% for Placebo
Slide 12: Future Plans
Future Plans • Phase II Clinical Trial in Metastatic Pleural Mesothelioma (MPM), a combination of OT-101 with a checkpoint inhibitor • Phase II Clinical Trial in NSCLC, combination study • Phase II Clinical Trial in a Basket Study, high grade gliomas (HGG), Tumors of the midline brain and diffuse in
Slide 13: Rationale for Immunotherapy Combination
Rationale for Immunotherapy Combination • Data supportive of improved OS with higher innate immune reservoir -> supplement with boost to innate immune reservoir (Cytokine -> IL2, Cell supplement -> NK or CART or ADCC • Patients exhibited variable dynamics in IL-8 levels whereby increases were observ
Slide 14: OT-101 Biomarker Program
OT-101 Biomarker Program • This is a combination of mesothelioma, lung, pancreatic, melanoma, DIPG, and GPM clinical trials in collaboration with Merck combining Keytruda with OT-101. • Tumor biopsy previous to treatment and post treatment will be used to generate predictive biomarkers for tumor res
Slide 15: Positive clinical outcome
Sequence of events Positive clinical outcome Illumina Panel for blood biomarker Spatial IHC NanoString nCounter® assays (I/O and Fibrosis Transcriptome Analysis Panels) Deep sequencing Positive finding on blood and Nanostring Panel 15
Slide 16: N i , Y. , So lim a n , A . , Jo
N i , Y. , So lim a n , A . , Jo e h l i n -Pr ice , A . e t a l . H i g h T G F -β si g n a t u r e p r e d ict s i m m u n o th e r apy r esis t a n ce i n g y n eco lo gic ca n cer p a t ien ts t r ea t ed w it h im m u n e c h ec kp o int in h ibit io n . P r e ci s. O n c . 5, 101 ( 2021) . A H
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