RenovoRx, Inc. · NASDAQ:RNXT
RenovoRx — MCI Pancreas Symposium 2021
34 slides from RenovoRx's conference presentation, November 2021
Slide 1: Potential Future Innovative Strategy for Pancreatic Cancer: Intra-Arterial Chemotherapy
Potential Future Innovative Strategy for Pancreatic Cancer: Intra-Arterial Chemotherapy Ripal T. Gandhi, MD, FSIR, FSVM Miami Cardiac & Vascular Institute Miami Cancer Institute Associate Clinical Professor, FIU Herbert Wertheim College of Medicine Associate Clinical Professor, USF School of Medicin
Slide 2: Disclosures
Disclosures Sirtex Medtronic BD Cordis Trisalus Life Sciences 2
Slide 3: = | Miami Cancer [&] Miami Cardiac & Vascular Institute
= | Miami Cancer [&] Miami Cardiac & Vascular Institute == | Institute beter
Slide 4: Miami Cancer Institute
Miami Cancer Institute Z| Miami Cancer Miami Cardiac & Vascular Institute set | Institute BAPTIST HEALTH SOUTH FLORIDA
Slide 5: Objectives
Objectives Overview of Pancreatic Cancer Locally Advanced Pancreatic Cancer (LAPC) Treatment of LAPC with Intra-Arterial Gemcitabine – Mechanism of Action Clinical Data Future Directions – TIGeR PaC Phase III Clinical Trial
Slide 6: Pancreatic Cancer
@®@@ Pancreatic Cancer 2 Miami Cancer a= | Institute
Slide 7: Pancreatic Cancer
Pancreatic Cancer • Pancreatic cancer is 3rd leading cause of cancer death in USA (projected 2nd leading cause by 2030) • 54,000 new cases per year in USA • Worldwide > 300,000 new cases/year PANCREATIC CANCER STAGING
Slide 8: Pancreatic Cancer Staging
Pancreatic Cancer Staging Tumor Description ynfined to the top layer not invaded as not In longest dimension r other part r other parts S or nerves er par creas o near d to other parts of the = Miami Cancer [&] Miami Cardiac & Vascular Institute mstitute ‘APTIST HEALTH SOUTH FLORIOA
Slide 9: Pancreatic Cancer
Pancreatic Cancer • STAGE 2 DISEASE: For localized disease, surgery possible with 20% 5 year survival • STAGE 3 DISEASE: For locally advanced pancreatic cancer (LAPC): • Not resectable because of vascular involvement (> 180 degree involvement of the SMA, Celiac or SMV/PV obstruction not amenable to
Slide 10: Pancreatic Cancer
Pancreatic Cancer • Gemcitabine and nab-paclitaxel (Abraxane®) was demonstrated to be superior over Gemcitabine alone1 • Challenges to Current Standard of Care • Limited Drug Penetration into Pancreatic Cancer • Systemic Side Effects / Toxicity • Survival for pancreatic cancer has only minimally imp
Slide 11: Locally Advanced Pancreatic Cancer
Locally Advanced Pancreatic Cancer • Local Control appears to be important for symptoms and survival in locally advanced pancreatic cancer (LAPC) • Several Potential Means for Local Control: • Radiation (SBRT, Proton Beam, MR Linac) • Irreversible Electroporation (IRE) – Nanoknife • Adenovirus/Gene
Slide 12: Technical Problem: Present Chemotherapy Regimens Have Limited Efficacy in Hypovascular Tumors
Technical Problem: Present Chemotherapy Regimens Have Limited Efficacy in Hypovascular Tumors Hypervascular Tumor Treatment with Hypovascular Tumors Post Major Barrier Current Therapies to Chemotherapy Treatment Success Liver tumors are highly vascularized Pancreatic tumors have poor blood supply •
Slide 13: Technical Problem
Technical Problem Liver tumors highly vascularized: Pancreas tumors are hypovascular: • Large tumor feeders – excellent • Challenge: Inability to identify or targets for therapy engage tumor feeder vessels • Large branches within tumor - • Opportunity: Familiar anatomy easily visualize tumor for int
Slide 14: One Possible Solution: Trans-Arterial Micro-Perfusion (RenovoTAMP)
One Possible Solution: Trans-Arterial Micro- Perfusion (RenovoTAMP)
Slide 15: RenovoCath Allows for Targeted Therapy
RenovoCath Allows for Targeted Therapy Double- balloon catheter Gemcitabine infusing target site + The RenovoCath™ System isolates the anatomy and micro-perfuses targeted tissue with gemcitabine
Slide 16: Targeted Delivery to Pancreatic Cancer: Trans-Arterial Micro-Perfusion (RenovoTAMP)
Targeted Delivery to Pancreatic Cancer: Trans-Arterial Micro-Perfusion (RenovoTAMP) 16
Slide 17: Trans-Arterial Micro-Perfusion (RenovoTAMP)
Trans-Arterial Micro-Perfusion (RenovoTAMP) Blood vessel segment is isolated to deliver Mechanism: after vessel isolation, increase in drug across blood vessel wall into tissue pressure forces drug into tissue At ~45mmHg - tissue pressure is 70 overcome, forcing chemotherapy out 60 of vessel Pressur
Slide 18: Mechanism: Trans-Arterial Micro-Perfusion (TAMP) combined with radiation
Mechanism : Trans-Arterial Micro- Radiation reduces venous Perfusion (TAMP) combined with outflow by decreasing the radiation microvasculature Distal RenovoCath™ Native vasculature and IA chemo lead Irradiated vasculature balloon to Micro-vascular washout and IA chemo lead to Diffusion Microvascular
Slide 19: RenovoCath for Transvascular Drug Delivery
RenovoCath for Transvascular Drug Delivery
Slide 20: Case Example
Case Example Isolated transvascular delivery to hepatic artery me 2 Catheter isolation balloons Isolated transvascular delivery to superior mesenteric artery
Slide 21: Clinical Trials and Results
®.@@. Clinical Trials and Results 2 Miami Cancer a= | Institute
Slide 22: RenovoCath in Pancreatic Cancer: Phase I/II Studies to Explore Clinical Endpoints
RenovoCath in Pancreatic Cancer: Phase I/II Studies to Explore Clinical Endpoints RR1- Dose Escalation Safety Study • Primary Endpoint: Safety, Max Tolerated Dose, Dose Limiting Toxicity • Secondary Endpoint: Survival • Completed July 2016 20 Patients • 101 Treatments RR2 – Observational Registry •
Slide 23: Results: Phase I and II Clinical Trials
Results: Phase I and II Clinical Trials • To date, 43 patients treated with Intra-Arterial Gemcitabine using RenovoCath between the 2 studies from May 2015 to Dec 2018 (2 patients rolled over from safety to registry study) • Average age of patient enrolled was 69.9 years • 24 of 43 patients had prio
Slide 24: Results: Phase I and II Clinical Trials
Results: Phase I and II Clinical Trials On average each pt. received four intra-arterial treatments, ranging from 1-14 treatments 13 of 43 patients completed the planned 8 treatments of IA therapy Reasons for early discontinuation of IA therapy: Tumor progression (n=12) Patient/physician prefere
Slide 25: Promising Data from Phase 1/2 and Observational Registry Studies Advanced Clinical Development Program to Phase 3
Promising Data from Phase 1/2 and Observational Registry Studies Advanced Clinical Development Program to Phase 3 *Chauffert, B. et al. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcita
Slide 26: CT Imaging Provides a Simple Approach to the Vasculature
CT Imaging Provides a Simple Approach to the Vasculature
Slide 27: Case Example
Case Example CA 19-9 Tumor Marker 2% | Miami Cancer [&] Miami Cardiac & Vascular Institute == | Institute ‘BAPTIST WEALTH SOUTH FLORIOA
Slide 28: Limitations of the Previous Studies
Limitations of the Previous Studies • Relatively Small Number of Patients • Non-Randomized • Selection Bias
Slide 29: Future Directions: TIGeR-PaC Randomized Phase 3 Clinical Trial
Future Directions: TIGeR-PaC Randomized Phase 3 Clinical Trial This study is to test the efficacy of approach as part of a phase 3 randomized clinical trial
Slide 30: TIGeR-PaC Randomized Clinical Trial – Phase 3 Multicenter Trial
TIGeR-PaC Randomized Clinical Trial – Phase 3 Multicenter Trial Trans (Intra)-arterial Gemcitabine vs. Continuation of IV Gemcitabine and Nab-Paclitaxel following Radiotherapy for Locally Advanced Pancreatic Cancer (TIGeR-PaC Randomized Clinical Trial) Prospective multicenter randomized clinical T
Slide 31: Phase 3 TIGeR-PaC RCT Study Schema
Phase 3 TIGeR-PaC RCT Study Schema
Slide 32: Systemic Levels of Gemcitabine Reduced by 2/3 with RenovoTAMP vs IV Gemcitabine
Systemic Levels of Gemcitabine Reduced by 2/3 with RenovoTAMP vs IV Gemcitabine
Slide 33: Conclusions
Conclusions Localized intra-arterial delivery of gemcitabine using RenovoCath demonstrates encouraging results in stabilizing local disease This benefit is especially pronounced in patients with prior induction therapy with radiation (median OS is 27.9 months) The phase 3 multicenter, randomized TIG
Slide 34: Thank You!
Thank You!