Oncotelic Therapeutics Inc · OTC:OTLC
Oncotelic Therapeutics — Technical Presentation (July 2022)
11 slides from Oncotelic Therapeutics's technical presentation, Jul 15, 2022
Slide 1: PK/PD Analysis for P001 - Phase 1/2 Clinical Trial for OT-101
Sapu Bioscience PK/PD Analysis For POO1 - Phase 1/2 Clinical Trial For OT-101 Against Pancreatic Cancer, Melanoma, and Colorectal Cancer Vuong Trieu'?, Cynthia Lee 1? ‘Sapu Bioscience, USA 2Oncotelic Therapeutics, USA
Slide 2: COI Disclosure Information
COI Disclosure Information Sap Bioscience Lead Presenter/Principal Researcher: Vuong Trieu | have the following financial relationships to disclose. WY Leadership position/advisory role for: CEO of Sapu Bioscience
Slide 3: Introduction
Introduction S apu Bioscience O Elevated levels of TGF-B2 in tumor tissue or plasma have been associated with poor survival in patients with advanced pancreatic carcinoma. Since numerous mechanisms of malignant progression in pancreatic cancer are closely related to the expression of TGF-B2, attempt
Slide 4: Phase I/II P001 trial of Trabedersen (OT-101)
Phase I/II POO1 trial of Trabedersen (OT-101) Sapu Bioscience O Study objectives O To determine the safety, pharmacokinetics and activity of OT-101 in patients with pancreas cancer, malignant melanoma, or colorectal cancer when administered intravenously Key patient inclusion criteria Pancreatic can
Slide 5: Promising Clinical Activity in Advanced Pancreas Cancer
Promising Clinical Activity in Advanced Pancreas Cancer a Bioscience Pati = fa 5 a = o re) 2 o a ent 1006: CR as far out as 77 mos Surgery: Whipple’s procedure 1* line: 5-FU/LV, Dose 425 mg/m2 2"4 line: 5-FU/LV, Dose 2600 mg/m2/24hr 3" line: Gemcitabine, Dose 1000 mg/m2/week OT-101- Liver mets/ Comp
Slide 6: Dosing and Sampling
Dosing and Sampling Sapu Bioscience Table 1. Dosing Scheme 0 The PK population consisted of 57 patients from Schedule Dose (mg/m?/day) Infusion Duration Number of Subjects the Phase VI study treated with OT-101 using “ pe : either 7-days-on/7-days-off or 7-days-on, 7-days- 80 7 days (168 h) al 4 d /
Slide 7: Demographic and Population PK
Demographic and Population PK Table 3. The demographic and indication index of the patients. Mean, SD. Characteristics 7-d-on/7-d-off 4-d-on/10-d-off Demographic Male Female Age, year BW, kg Height, cm BMI, kg/m? Indication Pan/Mel/Col Cancer 9 6 58.2 , 10.3 70.7 12.9 171.0 , 8.4 24.1, 3.4 9/2/4 18
Slide 8: PK/PD Analysis
PK/PD Analysis a Bioscience 0 OT-101 PK is dose proportional (p<0.0001) (Figure 2). O More than half of the OT-101 treated PC patients went into long term disease control (21 of 37 pts, 55%) allowing them to enter into subsequent chemotherapy which has an unexpected benefit of more than doubling the
Slide 9: Conclusions
Conclusions 5 apu Bioscience O Pharmacokinetic analysis of OT-101/trabedersen for P0O1 study was assessed over the first two cycles of 7- or 4-day intravenous infusions, separated by 7- or 10-day treatment-free interval, respectively, at doses of 40, 80, 140, 160, 190, 240, 250, and 330 mg/m2/day. P
Slide 10: OT-101 Clinical Trials
OT-101 Clinical Trials 4 SAPU BIOSCIENCE 4 SAPU BIOSCIENCE » SAPU BIOSCIENCE 4 SAPU BIOSCIENCE Discovery Oncology OT-101 -IV OT-101-IV OT-101- IV OT-101- IV OT-101- CED OT-101- CED Virology OT-101- IV Discovery OT-101/LNP OT-101/Intranasal Preclinical Solid Tumors Mesothelioma NSCLC PDAC DIPG/ RPD V
Slide 11: Thank you
Sapu Bioscience Thank you Dr. Vuong Trieu Sapu Bioscience Vuong.trieu@sapubio.com Cun
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