Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Mateon Therapeutics — Investor Presentation (April 2019)
29 slides from Oncotelic Therapeutics's investor presentation, Apr 30, 2019
Slide 1: TGF-b RNA Therapeutics Self Immunization Protocol (SIP) Against Cancers
TGF-b RNA Therapeutics Self Immunization Protocol (SIP©) Against Cancers Exhibit 99.1
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: Overview of Oncotelic/MATN Opportunity
Overview of Oncotelic/MATN Opportunity Oncotelic Inc. is a leader in TGF-β cancer immunotherapy Self Immunization Protocol (SIP®) using a TGF-β antisense (OT-101) OT-101 is designed to mobilize, stimulate and boost immunity against cancer Clinical efficacy demonstrated Broadly applicable to all soli
Slide 4: Oncotelic Corporate History
Acquired Trabedersen (OT-101) through an asset purchase Acquired rights to next-generation Trabedersen (LNA backbone from Roche) Completed Prolonged Follow-Up/Secondary Endpoints Analyses Invented Self Immunization Protocol (SIP®) leveraging on Trabedersen (OT-101) Built Patent portfolio around Self
Slide 5: Cancer - Current Landscape
Cancer- Current Landscape In 2015- cancer death increased globally to 8.8 million of the 55.8 million deaths- or 1 of every 6 deaths. In 2035- cancer death and new cases are projected to be 14.6 million and 24 million respectively. AACR Cancer Progress Report 2018 Although the robust gain in surviva
Slide 6: Cancer Vaccine
Cancer Vaccine Genetic mutations are characteristics of cancer and are associated with treatment failures. Harnessing innate immunity against these neoepitopes has potential lasting disease control Mutation-based vaccines are agnostic to the cancer type and universally applicable to any patient. How
Slide 7: TGF-β Self Immunization Protocol (SIP) - Oncotelic Invention
TGF-β Self Immunization Protocol (SIP©) - Oncotelic Invention TGF-β inhibitor (i.e. OT-101) lifts the immunosuppression and primes the innate immunity against the tumor. Subsequent chemotherapy boosts the immune response with epitope expansion due to neoantigens released during Xenogenization Mateon
Slide 8: TGF-β Is Centrally Important Target in Immunotherapy
TGF-β Is Centrally Important Target in Immunotherapy The overexpression of transforming growth factor-beta, specifically TGF-β2, plays a key role in malignant progression of various tumors by inducing proliferation, metastasis, angiogenesis, and immunosuppression Therefore, reducing TGF-β2 expressio
Slide 9: 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 Potential for breakthrough designation
Slide 10: OT-101: Clinical Efficacy - TGF-β2 Antisense
Proven tumor reduction in both treated and untreated tumors Safety demonstrated in >200 pts across more than 5 company sponsored trials PANCREAS GLIOMAS MELANOMA PROMISING CLINICAL ACTIVITY TGF-β platform to mobilize, stimulate and boost immunity against cancer Placement in front of standard chemoth
Slide 11: Optimal Sequencing for TGF-β Self Immunization Protocol
Optimal Sequencing for TGF-β Self Immunization Protocol Proper Sequencing is key to optimal immunotherapy Expand immune reserve through IL-2 treatment or infusion of immune cells Prime immune response with TGF-β inhibitor- OT-101 Boost immune response with chemotherapy Revitalize the exhausted of im
Slide 12: SIP Pipeline Built Around Sequencing
Preclinical Animal POC Phase 1 POC Phase 2 Phase 3 SIP© Pipeline Built Around Sequencing Hypermutation Brain Cancer/ OT-101 + TMZ ICD Pancreatic Cancer/ OT-101 + ABX Solid tumors/ OT-101 + NK/IL-2/Partnered Discovery Pipeline Nanoparticle OT-101 Companion Prognostic Testing IL/8 and IL-15 Spike Panc
Slide 13: Prime->Boost - Glioblastoma: OT-101/TMZ
Prime->Boost - Glioblastoma: OT-101/TMZ G004-Phase 2b trial Title: A multi-national, multi-center, open-label, active-controlled, randomized parallel-group dose-finding study to evaluate the efficacy and safety of two doses of OT-101 in adult patients with recurrent high-grade glioma, administered i
Slide 14: OT-101 Single Agent Activity: Objective Responses
OT-101 Single Agent Activity: Objective Responses Objective responses were observed among the 87 evaluable patients treated with OT-101: Best Objective Responses were: 5 CR (5.9%), 14 PR (16.5%), 28 SD (31.8%), and 40 PD (45.9%) Confirmed Best Objective Responses were: 4 CR (4.7%), 12 PR (12.9%), 31
Slide 15: OT-101/Chemo Combination Activity (Immunity Boost)
OT-101/Chemo Combination Activity (Immunity Boost) Subsequent chemotherapy after OT-101 should release neoantigen via immunogenic cell death and thereby reeved up immunity against the tumors There were 18 and 44 chemo naïve pts treated with SC (Standard Chemotherapy – mostly TMZ) and OT-101. OT-101
Slide 16: Prime->Boost - Pancreatic Cancer: OT-101/Taxanes
Prime->Boost - Pancreatic Cancer: OT-101/Taxanes P001- Phase 1/2 Clinical Trial Title: An Open-Label, Multicenter Dose-escalation Study to Evaluate the Safety and Tolerability of OT-101 (TGF-β2-specific Phosphorothioate Antisense Oligodeoxynucleotide), Administered Intravenously in Adult Patients wi
Slide 17: P001 Phase 1/2 Trial: Single Agent Activity
P001 Phase 1/2 Trial: Single Agent Activity Patient 1006: CR as far out as 77 mos Surgery: Whipple’s procedure 1st line: 5-FU/LV, Dose 425 mg/m2 2nd line: 5-FU/LV, Dose 2600 mg/m2/24hr 3rd line: Gemcitabine, Dose 1000 mg/m2/week OT-101- Liver mets/ Complete Response (Black Line) Patient 1022: OS of
Slide 18: OT-101/Chemo Combination Activity (Immunity Boost)
OT-101/Chemo Combination Activity (Immunity Boost) Only pts with disease control (DC) were entered into the analysis to eliminate as they are healthy enough to able to enter subsequent chemotherapy if they desired OT-101 treatment more than doubled the ratio of patients being able to go onto subsequ
Slide 19: Expand->Prime->Boost: CRC/Solid Tumors: IL-2/NK/OT-101/Taxanes
Expand->Prime->Boost: CRC/Solid Tumors: IL-2/NK/OT-101/Taxanes P001- Phase 1/2 Clinical Trial OT-101 treated Patients exhibited variable dynamics in IL-8 levels whereby increases were observed during cycles 1 (days 2, 5), 2 (days 1, 2, 5) and 3 (day 5). R2 squares were 0.8522 and 0.9895 and p values
Slide 20: Preclinical POC: PBMC as Expander of Immune Reservoir
Preclinical POC: PBMC as Expander of Immune Reservoir/Enhancer of OT-101 Preclinical- LS174T colorectal xenograft was treated with PBMC or PBMC + OT-101. OT-101 significantly enhanced the activity of PBMC against the xenograft. Clinical- OT-101 treatment resulted in delayed tumor response typical of
Slide 21: Preclinical POC: IL-2 as Expander of Immune Reservoir
Preclinical POC: IL-2 as Expander of Immune Reservoir/Enhancer of OT-101 In vitro- OT-101 (AP 12009) reduced TGF-β2 secretion and increased LAK cell-activity against all tumor lines by 400% and 364% in comparison to the untreated control and compared to the Lipofectin control, respectively. Addition
Slide 22: Prime->Boost->Revitalize - Melanoma: OT-101/CA4P/CTLA4
Prime->Boost->Revitalize- Melanoma: OT-101/CA4P/CTLA4 P001- Phase 1/2 Clinical Trial Pts#: 61 (37 with pancreatic cancer; 19 with malignant melanoma; 5 with colorectal cancer) OT-101 was well tolerated. MTD not reached and Efficacy Demonstrated mOS comparable to other treatment protocols including Y
Slide 23: Preclinical POC - CA4P + CTLA4
Preclinical POC- CA4P + CTLA4 CA4P Induces Massive Tumor Destruction Following Rapid Ischemic Necrosis which Leads to presentation of numerous tumor-specific NeoAntigens. CA4P alone was carved out as legacy asset per the Mateon’s CVR agreement When used in combination with checkpoint inhibitors: 1)
Slide 24: Expand -> Prime - MDS: OT-101
Expand -> Prime- MDS: OT-101 Acceleron Pharma presented positive phase 3 trial for their TGF-β trap- luspatercept at ASH (Dec 2018). This allows for the acceleration of OT-101 clinical development along the same track and further validate TGF inhibitor as a valid therapeutic agent. The Acceleron’s M
Slide 25: MEDALIST Phase 3 Trial: Primary Endpoint Subgroup Analysis
OR, odds ratio. 00.1 0.25 0.521020100 1,500 Favors placeboFavors luspatercept MEDALIST Phase 3 Trial: Primary Endpoint: Subgroup Analysis Luspatercept, n (%) Placebo, n (%) OR (95% CI) P Value Overall 58/153 (37.9) 10/76 (13.2) 5.06 (2.28–11.3) < 0.0001 Average baseline RBC transfusion requirement ≥
Slide 26: Prime -> Boost - MDS: OT-101/OXi4503/Cytarabine
Prime -> Boost- MDS: OT-101/OXi4503/Cytarabine Pts who continued to progress on OT-101 treatment when bone marrow blast <5% per Medalist trial design with presentation of bone marrow blast > 5% can go onto OT-101/OXi4503 combination. OXi4503 was carved out as legacy asset per the Mateon’s CVR agreem
Slide 27: Management Team
Management Team Matthew Loar CPA Chief Financial Officer Fatih Uckun MD PhD Chief Medical Officer Chulho Park PhD Chief Technology Officer Vuong Trieu PhD Chief Executive Officer
Slide 28: Board of Directors
William D. Schwieterman, MD - Director Previously Chief of the Medicine Branch and Chief of the Immunology and Infectious Disease Branch in the Division of Clinical Trials at the Food and Drug Administration (FDA). In these capacities and others, Dr. Schwieterman spent 10 years at the FDA in the Cen
Slide 29: Key financial data Mateon/Oncotelic
Key financial data Mateon/Oncotelic- (OTCQB:MATN) Pro Forma MATN Stock information: Ticker (OTCQB) MATN Price (3/6/2019) $0.15 Market Cap ~$40 million Average Daily Trading Volume ~45,000 Thank You Vuong Trieu PhD CEO/ Chairman vtrieu@oncotelic.com www.oncotelic.com
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