Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Mateon Therapeutics — Corporate Update (June 2020)
19 slides from Oncotelic Therapeutics's corporate update, Jun 18, 2020
Slide 1: Building the next generation biotech focusing on speed and efficiency
MATEON Building the next generation biotech focusing on speed and efficiency IMMEDIATE THERAPEUTIC RESPONSE TO COVID-19: OT-101/TRABEDERSEN MAY 22, 2020 WWW MATEON COM WWW ONCOTELIC. COM ONCOTELIC
Slide 2: Overview of Mateon - A Delaware Corporation
MATEON OVERVIEW OF MATEON- A DELAWARE CORPORATION PointR oncoreuc - MATEON Edge Computing Antisense Platform TGF-B Vision Grid -Target to FIH < lyr -A critical target in -Back office support -Exceptional Stability (>30 yrs) Oncology and COVID-19 -Blockchain/Smart Protocol Antisense Drug Cluster- com
Slide 3: Proven and Experienced Response Team
PROVEN AND EXPERIENCED RESPONSE TEAM Clinical: ¢ Fatih Uckun MD PhD (SME and Critical Care Advisor): VP and Clinical Strategy Lead, COVID-19 Task Force, Worldwide Clinical Trials. Currently overseeing multiple COVID-19 trials contracted to WCT. More than 20 years of clinical experience in treatment
Slide 4: OT-101: A High Impact Technology Platform
OT-101: A HIGH IMPACT TECHNOLOGY PLATFORM Trabedersen (OT-101) is a single-stranded phosphorothioate antisense oligodeoxynucleotide (18-mer) designed to specifically target the human TGF-B2 messenger RNA OT-101 can impact COVID-19 as well as other viral threats requiring TGF-B. OT-101 antiviral acti
Slide 5: OT-101 Inhibits SARS-CoV-1 and SARS-CoV-2 Replication
MATEON OT-101 INHIBITS SARS-COV-1 AND SARS-COV-2 REPLICATION ¢ Incollaboration with Dr. Brett Hurst at Utah State University, part of the NIAID Antiviral Testing Consortium * Invitro antiviral activity against SARS-CoV-1 and SARS-CoV-2 in Vero 76 cells. Compound Virus Eg cc. Sl OT-101 SARS-CoV-1 (Ur
Slide 6: Mice Lacking Epithelial TGF-Beta Are Protected From Influenza Challenge
MATEON MICE LACKING EPITHELIAL TGF-BETA ARE PROTECTED FROM INFLUENZA CHALLENGE. (a) Schematic illustrating p B Weight change breeding scheme to generate epithelial TGFRKO mice. (b) Percentage weight loss after influenza infection; stars represent level of significance between infected epTGFBKO and c
Slide 7: MOA of OT-101: The TGF-B Storm Antiviral Concept
MATEON MOA OF OT-101: THE TGF-B STORM ANTIVIRAL CONCEPT * Untreated: Host cell-derived TGF-f is rapidly released * OT-101:, viral replication is suppressed, IFNB is induced, into the airways after viral infection, suppressing IFNB and innate and adaptive immune responses suppressed. responses. This
Slide 8: Patient Pathway in COVID-19
Patient Pathway in COVID-19 COVID-19 Cough, fever Physical Treatment, Exposure, and onset Evaluation Patient Supportive Care, Disciaige nectar dyspnea @ER or Admitted Ventilation, Cardiac Criteria Symptoms worsening over Clinic Support Met >1 week COVID-19 patients may have a very mild course and ra
Slide 9: Rationale for Targeting TGF-B with Trabedersen/OT-101 in Treatment of COVID-19
RATIONALE FOR TARGETING TGF-B WITH TRABEDERSEN/OT-101 IN TREATMENT OF COVID-19 * Our WORKING HYPOTHESIS is that the anti-TGF-B RNA therapeutic OT-101 will prevent the progression of disease from mild to moderate or severe in hospitalized COVID-19 patients * We postulate that OT-101 may also decrease
Slide 10: Rationale for Targeting TGF-B with Trabedersen/OT-101 in Treatment of COVID-19
RATIONALE FOR TARGETING TGF-8 WITH TRABEDERSEN/OT-101 IN TREATMENT OF COVID-19 ¢ TGF-B increases capillary permeability and impairs alveolar fluid reabsorption in ARDS patients contributing to persistence of pulmonary edema ¢ Upregulation of TGF-B in ARDS causes an ENAC trafficking defect thereby ra
Slide 11: Rationale for Targeting TGF-B in COVID-19 (Kawasaki Disease)
RATIONALE FOR TARGETING TGF-B WITH TRABEDERSEN/OT- 101 IN TREATMENT OF COVID-19 (KAWASAKI DISEASE) Some children with COVID-19 have developed Kawasaki disease (KD), sometimes accompanied by a “multi-system inflammatory syndrome” with potentially life-threatening complications. Reminiscent of the cyt
Slide 12: Regulatory Strategy/Approach
MATEON REGULATORY STRATEGY/APPROACH: * OT-101/Trabedersen has an active IND in Oncology with extensive nonclinical and clinical data as well as ample drug supply. ° An Investigational New Drug (IND 149299) application to treat patients with COVID-19 has been submitted to FDA on April 23, 2020. * Thi
Slide 13: OT-101: Proposed Phase IIA/III Clinical Trial Design for COVID-19
MATEON OT-101: PROPOSED PHASE IIA/III CLINICAL TRIAL DESIGN FOR COVID-19 COVID-19 Patients Phase IIA Trial -part 1- w/o oxygen requirement -part 2- w/ oxygen requirement Phase III N~ 300 2:1 Randomization Size and Indication dependent on phase IIA outcome R A N D 2 M i Zz E Arm 1 Arm 2 OT-101 Dose:
Slide 14: OT-101 — Summary
OT-101 — SUMMARY Neutralize the TGF-B storm central to COVID-19 Neutralize Respiratory Viruses including COVID-19 MATEON Robust Human Clinical Experience Drug Readiness ¢ Inhibits viral replication and not affected by viral mutations Suppresses virus- induced lung inflammation and pneumonia. ¢ Suppr
Slide 15: Thank You
MATEON Thank You Vuong Trieu/ vtrieu@oncotelic.com Saran Saund/ saran.saund@oncotelic.com Amit Shah/ ashah@oncotelic.com Cyril Empig/ cempig@oncotelic.com
Slide 16: Antisense as Platform Technology
ANTISENSE AS PLATFORM TECHNOLOGY ¢ Favorable Properties: Rational Design, High Success Rate, Predictable PK, Predictable off target tox, Low risk profile, Low manufacturing cost, Amenable to personalized therapy. * Rapid development- sequence to FIH in 12 months/ Sequence to Drug Candidates in weeks
Slide 17: Preclinical: Role of TGF-B in Viral Replication and Pathophysiology
PRECLINICAL: ROLE OF TGF-B IN VIRAL REPLICATION AND PATHOPHYSIOLOGY ¢ TGF-B promotes viral replication and contributes to pathogenicity of respiratory viruses1-7 * Viruses with documented up regulation of TGF-B during infection and replication: SARS-CoV-2, PRRSV, EBOLA, SARS, MERS, RSV, Rhinovirus,
Slide 18: OT-101: Prior Clinical Experience in Gliomas, Pancreas and Melanoma Cancers
OT-101: PRIOR CLINICAL EXPERIENCE IN GLIOMAS, PANCREAS AND MELANOMA CANCERS * 6 Clinical Trials with more than 200 pts / 189 pts treated with OT-101 ° Robust Efficacy against multiple TGF-B expressing tumors PROMISING PANCREAS CLINICAL mn Re é GLIOMAS ACTIVITY A Z MELANOMA Trial |Trabedersen ation M
Slide 19: OT-101: Favorable Safety Profile - Low Toxicity
MATEON OT-101: FAVORABLE SAFETY PROFILE- LOW TOXICITY ° Low Related Adverse Events — P001 * Pancreatic Cancer/ Melanoma/ Colorectal Cancer/N =total number of patients; No. = number; TEAE = treatment- emergent adverse event; FAS = full analysis set Preferred Term ieee (N=61) 6 (9.8)/21 [Fatigue (e/a