Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Investor Presentation (December 2020)
33 slides from Oncotelic Therapeutics's investor presentation, Dec 1, 2020
Slide 1: Ethnobiology drug development for COVID-19 and future pandemics
0 7 . 0 3 Ethnobiology drug development for . 2 0 COVID-19 and future pandemics 1 8 ARTIVEDA™/ OT-101/ COVID-19 DEC 1, 2020 WWW.MATEON.COM 1
Slide 2: Forward-looking Statements
Forward-looking Statements This document contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in thi
Slide 3: Building the next generation biotech focusing on speed and efficiency
Building the next generation biotech focusing on speed and efficiency 07.03.2018 Covid-19 Therapeutics Cluster- Antisense 1) OT-101 TGF-β target TGF-β antisense computing Drug 2) Artemisinin TGF-β inhibitor 3
Slide 4: We need new treatments for Covid-19, not just a vaccine
Yes, we need a vaccine to control Covid-19. But we need new treatments, too 07.03.2018 By Karen Mulligan and Karen Van Nuys/August 5, 2020 and John Whyte, MD, MPH; Davey Smith, MD/October 06, 2020 Treatments are an essential A vaccine is not a silver An economic model from part of the Covid-19 fight
Slide 5: And the virus will keep mutating
07.03.2018 And the virus will keep mutating Fourth state confirms mink farm coronavirus outbreaks as U.S. looks to avoid Denmark’s disaster. Oregon had become the fourth state to confirm a coronavirus outbreak on a domestic mink farm. Danish minks were culled en masse weeks earlier after scientists
Slide 6: Conventional COVID-19 Response Programs
07.03.2018 Conventional COVID-19 Response Programs Trillions of dollars/ Countless manhours 1 without a therapeutic Traditional Drug in sight Time to revamp the conventional approach
Slide 7: Large WHO SOLIDARITY Trial and UK RECOVERY Trial – Conventional COVID-19 Therapeutics
07.03.2018 Conventional COVID-19 Therapeutics Drug Name Mechanism/ Target Outcome Trial Name/N Lopinavir Antiviral/ Protease Inhibitor Fail WHO SOLIDARITY/ 1411 UK RECOVERY/ 1616 Large WHO Hydroxychloroquine Antiviral/ Antimalarial/ TRL Fail WHO SOLIDARITY/ 954 SOLIDARITY Trial and UK RECOVERY/ 790
Slide 8: Plus and Minus with conventional pathway
07.03.2018 Plus and Minus with conventional pathway ➢ Highly bureaucratic and Expensive infrastructure ➢ IRB Approval/ Regulatory Approval /Import permit ➢ Logistics/ Site training/ Pts Recruitment ➢ Solidarity Trial- Example of a rapid reponse trial: 11 Feb/ Concept => 6 Mar/ Protocol => 18 Mar/ La
Slide 9: TGF-β Positive Feedback Loop
TGF-β Positive Feedback Loop 07.03.2018 ➢ SAR-CoV-2 infection upregulates TGF-β and Furin. Stukalov A et al. bioRxiv.2020.06.17.156455 ➢ TGF-β locks cell cycle allowing the virus to replicate. ➢ TGF-β drives the expression of Furin- a protease required for the cellular entry of SARS-CoV-2. In Furin-
Slide 10: Impacts of TGF-β Surge
07.03.2018 Impacts of TGF-β Surge ➢ TGF-β recruits neutrophils into the site of inflammation laying down neutrophil extracellular traps (NET’s) responsible for capillaritis, fibrin deposition, mucositis in COVID-19 [Barnes BJ et al. J Exp Med. 2020;217(6):e20200652.]. NETs • Inflammation • Thrombosi
Slide 11: COVID-19 Clinical Trials- Hypercompetitive
07.03.2018 COVID-19 Clinical Trials- Hypercompetitive ➢ 3,807 studies on ClinicalTrial.gov ➢ 753 studies on CTRI- India clinical trial registry ➢ US COVID 19 ➢ Highly competitive environment. ➢ Low infection rate => too many trials competing ➢ High infection rate => too busy treating patients ➢ Ex-U
Slide 12: A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study of OT-101 in COVID-19 Subjects
A Double-Blind, Randomized, Placebo- Controlled, Multi-Center Study of OT-101 in COVID-19 Subjects 27 Oct 2020--------------First patient in expect Dec 15 and top line data 1Q21 Copyright © 2020 Covance. All Rights Reserved.
Slide 13: C001 Leads
C001 Leads Kathy Carter Vuong Trieu Anthony Maida Covance Senior Project Manager, Oncotelic Chief Executive Officer Oncotelic Chief Clinical Officer Project Lead Norberto Soto, MD Kimberly Goldapple Alexandra Agudelo Matthew Smith Giovana Mainardi Covance Lead Project Physician Covance Clinical Team
Slide 14: COVID-19 Clinical Course After SARS-CoV-2 Infection and the OT-101 Trial
COVID-19 CLINICAL COURSE AFTER SARS -COV-2 INFECTION AND THE OT-101 TRIAL Eligible Hospitalized Patients Eligible Hospitalized Patients Positive for COVID-19: Positive for COVID-19: OT-101 IV • Mild Disease (WHO Ordinal Scale 3 and 4) • Severe Disease (WHO Ordinal Scale 5 and 6) x 7 days + S0C Prima
Slide 15: In vitro antiviral activity of OT-101 against SARS-CoV-2
UCKUN FM, TRIEU V. ANNA PUL AND CRI CAR MED..2020; 3(1); 01-09. • The in vitro antiviral activity against SARS-CoV-2 (USA_WA1/2020 strain) was tested in Vero 76 cells in collaboration with Dr. Brett Hurst at Utah State University that is part of the NIAID Antiviral Testing Consortium. • OT-101- an a
Slide 16: TGF-β Surge in COVID-19
07.03.2018 TGF-β Surge in COVID-19 ➢ Elevated TGF-β2 expression among RNAs isolated from the bronchoalveolar lavage (BAL) fluid of COVID-19 patients versus normal controls has been reported [Xiong Y et al. Emerg Microbes Infect. 2020;9(1):761-770]. ➢ TGF-β is higher among severe COVID-19 patients. N
Slide 17: Objectives
Objectives Evaluate the safety and efficacy of OT-101 when used in combination with SoC: Primary Efficacy: Proportion of subjects with clinical improvement score (measured by an 8 point WHO COVID 19 Clinical Improvement Ordinal Scale) at Day 14 Safety: Adverse events, clinical labs, ECG, vital signs
Slide 18: Study Design
Study Design Randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of OT-101 when used in combination with SoC in hospitalized subjects with mild or severe COVID- 19. Sites and Subject Population ➢ Approximately 6 sites in Peru and Argentina. ➢ Adult s
Slide 19: Ethnobiology COVID-19 Response Program
07.03.2018 Ethnobiology COVID-19 Response Program - Masks - Social Distancing - Hand Washing ArtiVeda - Dexamethasone - ArtiShieldTM/ARTIV edaTM/ Artemisinin Co-Evolution Ethnobiology/Ayurveda ArtiVedaTM
Slide 20: Plus and Minus with Ayurvedic pathway
07.03.2018 Plus and Minus with Ayurvedic pathway ➢ Manufacturing- Marked variations are observed amongst the same formulations manufactured by different companies and by the same company. This raises questions on the quality standards. ➢ Nearly 21% of commercially available formulations contained de
Slide 21: Artemisinin vs. Artemisinins
07.03.2018 Artemisinin vs. Artemisinins ➢ Ayurveda- Broad Activity/ Low Specificity ➢ Allopathic- Narrow Activity/ High Specificity ➢ Appropriate for rapid response to pandemic ➢ Appropriate for safe and effective drugs Malaria
Slide 22: Financial Cost – Artemisinin versus Remdesivir
07.03.2018 Financial Cost – Artemisinin versus Remdesivir ➢ The ideal therapies should be inexpensive and prophylactic and should be able to be administered to: 1) non-hospitalized persons at the time of their initial diagnosis. 2) individuals with appearance of potential symptoms. 3) healthy indivi
Slide 23: Ayurveda - Dvipaantara Damanaka
Ayurveda - Dvipaantara Damanaka 07.03.2018 ➢ ArtiVedaTM is the Ayurveda - Dvipaantara Damanaka- and is labeled as capsule containing Artemisia Powder 500mg. ➢ Its approved use is per Ayurvedic text: fever and inflammation. Ayurveda is part of the principal medicinal system in India for centuries. ➢
Slide 24: In Silico Activities against SARS-CoV2
07.03.2018 In Silico Activities against SARS-CoV2 ➢ Molecular basis for drug repurposing to study the interface of the S protein in SARS-CoV-2 and human ACE2 through docking, characterization, and molecular dynamics for natural drug candidates. Meshari Alazmi & Olaa Motwalli ➢ ZINC natural library w
Slide 25: Artemisinin/ TGF-β Inhibitor/ In Vitro Antiviral Activity
07.03.2018 Artemisinin/ TGF-β Inhibitor/ In Vitro Antiviral Activity ➢ Artemisinin is an active component of ArtiVedaTM. ➢ Artemisinin is able to inhibit human TGF-β and is able to neutralize SARS-CoV-2 (COVID-19) in vitro at an EC50 of 0.45 ug/ml (based on Mateon’s test result at Utah State Univers
Slide 26: Safety and Efficacy of Artemisinin-Piperaquine for Treatment of COVID-19
“S AF E T Y AN D E F F I C AC Y O F ART E M I SI NI N -PI PERA QUI NE ( A P ) F O R T R E AT M E NT O F CO VI D - 1 9” I N T J AN T I M I C ROB I AL AG E N T S . 2 0 2 0 N O V 2 • Two groups: artemisinin-piperaquine (AP) group (n=23) and control group (n=18). • Primary outcome: time taken to reach u
Slide 27: Safety and Efficacy of Artemisinin-Piperaquine: Results
“S AF E T Y AN D E F F I C AC Y O F ART E M I SI NI N -PI PERA QUI NE ( A P ) F O R T R E AT M E NT O F CO VI D - 1 9” I N T J AN T I M I C ROB I AL AG E N T S . 2 0 2 0 N O V 2 • Piperaquine and hydroxychloroquine are members of the quinoline family and they both have marginal activity against SARS
Slide 28: We can stop the pandemic with % reduction in days being infectious
W E C AN S TO P T H E PAN D E MIC W I T H 5 0 % R E D U C TI ON I N DAYS B E I N G I N F E C T IOU S • w/o intervention/ per 1M populace • Continuing growth in infection • Fatalities =16,000 • Peak Hospitalization = 82,000 Peak: 82,818 First death hospitalizations • w/ intervention/ per 1M populace
Slide 29: Current Clinical Program for Artemisinin/ArtiVeda
Current Clinical Program for Artemisinin/ArtiVeda ARTI-19 29
Slide 30: Prospective, Randomized Study of Damanaka 500 mg Capsule in Adults with COVID-19
A PROSPECTIVE, RANDOMIZED, MULTI-CENTER, OPEN LABEL, INTERVENTIONAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF DAMANAKA 500 MG CAPSULE IN TREATMENT OF ADULT SUBJECTS WITH COVID -19 Global trial with 3 sites open in India: Arms opening in: • Maharashtra • Nigeria • Andhra Pradesh • Peru • Utter Pra
Slide 31: ARTI-19 Clinical Trial in India
ARTI-19 CLINICAL TRIAL IN INDIA • Open label, 2nd Arm control, multi-center Phase IV study • Compares the efficacy of ORAL doses with standard-of- care (SOC) versus SOC alone. • SOC is per Clinical Management Protocol • Moderate cases (WHO scale 4-5), patients skewed towards moderate • 2:1 randomiza
Slide 32: Efficacy in ARTI-19 India
EFFICACY IN ARTI-19 INDIA • At present: 78 pts randomized into ARTI-19 • Dec 15th: Complete randomization of 120 pts/ Interim Report for 60 pts/ EUA application. ARTIVedaT M+SOC • Beyond Dec 15th: Expansion to 6 sites and 300 pts/Global 80 Reduction of WHO Scale of 4=> 3 expansion 3000 pts Reduction
Slide 33: Conclusions
Conclusions 07.03.2018 • Artemisinin activity against COVID-19 is well supported at all levels: in silico, in vitro, and clinical • It is the only potentially prophylactic agent and cost-effective agent • Such an agent is needed to stop the pandemic even in the presence of an effective vaccine • It
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