RenovoRx: Revolutionizing Cancer Treatment with Groundbreaking Therapies and a $1B Market Opportunity
RenovoRx leverages its innovative TAMP™ platform to deliver life-saving therapies with significant survival benefits and reduced side effects, positioning itself as a leader in addressing high unmet medical needs.
About RenovoRx
RenovoRx is a late-clinical stage biopharmaceutical company dedicated to developing innovative targeted combination therapies for the treatment of hard-to-treat cancers. The company's flagship technology, the Trans-Arterial Micro-Perfusion (TAMP™) platform, is designed to enhance the therapeutic index of chemotherapeutic agents by delivering higher concentrations of the drug directly to the tumor site while minimizing systemic exposure and associated side effects. RenovoRx’s lead product candidate, RenovoGem™, is currently undergoing a pivotal Phase III clinical trial for locally advanced pancreatic cancer (LAPC). Interim results from this trial have demonstrated significant improvements in overall survival and a substantial reduction in adverse events, highlighting the potential of RenovoGem™ to set a new standard in cancer treatment.
Founded in 2009 and headquartered in Los Altos, California, RenovoRx has garnered significant industry recognition, including FDA Orphan Drug Designation for RenovoGem™ in the treatment of pancreatic and bile duct cancers. The company's pipeline is robust, with additional indications for RenovoGem™ under investigation, including bile duct cancer and glioblastoma. By leveraging its proprietary TAMP™ platform, RenovoRx aims to address the high unmet medical needs of patients with solid tumors that are difficult to treat with conventional therapies. With a strong leadership team and a strategic focus on expanding its innovative therapy platform, RenovoRx is well-positioned to make a meaningful impact on the future of cancer treatment.
LATEST NEWS
RenovoRx Increases Production of FDA-Cleared RenovoCath® Delivery System in Response to Strong Demand from Oncology and Interventional Radiology Physicians
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Innovative Treatment Platform
RenovoRx (NASDAQ: RNXT) is at the forefront of revolutionizing cancer treatment with its proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform. TAMP™ is an innovative approach designed to ensure the precise delivery of both existing and novel oncology agents directly to the tumor. This targeted method significantly minimizes the toxicities typically associated with systemic (intravenous) chemotherapy, offering patients increased safety, better tolerance, and improved efficacy. The lead product candidate utilizing this platform, RenovoGem™, is a novel drug-device combination currently undergoing evaluation in the Phase III TIGeR-PaC clinical trial for locally advanced pancreatic cancer (LAPC) under the oversight of the FDA’s Center for Drug Evaluation and Research.
The TAMP™ platform works by leveraging the peripheral vascular system for localized chemotherapy delivery. The patented delivery system, inserted through a small incision in the patient’s leg, features a double balloon design that allows physicians to isolate specific sections of the blood vessel. By adjusting the distance between the balloons, the system excludes branching blood vessels and creates the necessary pressure to push chemotherapy across the blood vessel wall, effectively bathing the tumor in the therapeutic agent. This localized approach is especially beneficial for tumors like those found in pancreatic cancer, which lack visible feeder blood vessels and are poorly served by traditional systemic chemotherapy.
The potential of the TAMP™ platform extends beyond pancreatic cancer. Its ability to deliver high concentrations of chemotherapy directly to the tumor site while reducing systemic exposure could transform the treatment landscape for various solid tumors. The ongoing Phase III TIGeR-PaC trial has already shown promising results, with a 6-month median overall survival benefit and a significant reduction in side effects compared to standard care. By continuing to refine and expand the application of the TAMP™ platform, RenovoRx aims to address critical gaps in cancer treatment, providing new hope for patients with difficult-to-treat tumors.
RenovoRX
(NASDAQ: RNXT)
Promising Clinical Pipeline
RenovoRx is dedicated to transforming the lives of cancer patients by developing innovative solutions that change the current paradigm of cancer care. The company's commitment is reflected in its lead product candidate, RenovoGem™, a novel oncology drug-device combination designed to deliver targeted chemotherapy with reduced systemic toxicity.
RenovoGem utilizes the proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform to provide localized delivery of gemcitabine, a chemotherapy agent, directly to tumor sites. This method aims to enhance the efficacy of the drug while minimizing the debilitating side effects commonly associated with systemic (intravenous) chemotherapy.
RenovoGem is currently being evaluated in the Phase III TIGeR-PaC clinical trial for the treatment of locally advanced pancreatic cancer (LAPC). This trial, regulated under the FDA’s 21 CFR 312 pathway, is investigating the effectiveness of RenovoGem in improving patient outcomes. The innovative approach of pressure-mediated delivery allows the chemotherapy to bathe the tumor tissue directly, potentially offering a significant improvement in treatment efficacy.
Additionally, RenovoGem has received FDA Orphan Drug Designation for pancreatic cancer, providing seven years of market exclusivity upon NDA approval. These designations and advancements in clinical trials underscore the potential for RenovoGem to become a groundbreaking treatment in the oncology field, attracting significant attention from investors seeking promising biopharmaceutical opportunities.
Beyond pancreatic cancer, RenovoGem is set to be evaluated in a Phase III clinical trial for bile duct cancer (extrahepatic cholangiocarcinoma, or eCCA) in late 2023. This rare and aggressive cancer forms in the bile ducts and is often diagnosed at an advanced stage, making effective treatment crucial.
RenovoRx has also secured FDA Orphan Drug Designation for cholangiocarcinoma, which could grant seven years of exclusivity if RenovoGem is approved for this indication. Further, RenovoRx is exploring preclinical studies to extend the application of RenovoGem to other solid tumors, including non-small cell lung cancer, uterine tumors, and glioblastoma, indicating a broad potential for its innovative therapy platform.
The expanding pipeline of RenovoGem applications represents a significant growth opportunity for RenovoRx, potentially driving substantial returns for investors.
The ability to target multiple high-need cancer indications with a single, versatile therapy platform enhances the company's market position and investment appeal. Additionally, the orphan drug designations and ongoing clinical trials signal strong regulatory support and a clear path to commercialization, making RenovoRx a compelling investment opportunity in the biopharmaceutical sector.
Strategic Market Position and Growth Potential
RenovoRx is strategically positioned to capture a significant share of the oncology market with its innovative therapy platform. By focusing on the targeted delivery of chemotherapy directly to tumors, RenovoRx aims to improve treatment efficacy and reduce harmful side effects, addressing a critical need in cancer care.
The global oncology market is expected to grow substantially over the next decade, driven by increasing cancer rates and advancements in treatments. RenovoRx’s TAMP™ platform is well-suited to capitalize on this growth, particularly with its potential applications for treating hard-to-reach tumors such as those in pancreatic and bile duct cancers. Pancreatic cancer alone has a worldwide incidence of 495,000 new cases annually, with 30% of these cases being locally advanced at presentation. In the U.S., it is projected to become the second leading cause of cancer-related deaths, accounting for 48,000 deaths annually.
RenovoGem™, RenovoRx’s lead product candidate, is positioned to address the high unmet need in treating locally advanced pancreatic cancer (LAPC). The current standard of care for LAPC includes chemotherapy regimen, which offer a median overall survival of 12 to 18.8 months from diagnosis.
However, only three drugs have been approved by the FDA for LAPC in the past decade, each providing less than a two-month median overall survival benefit and associated with increased toxicity rates. RenovoGem aims to surpass these benchmarks, with independent interviews suggesting oncologists would likely adopt RenovoGem if it demonstrates a four-month overall survival benefit and improved toxicity profile.
Additionally, RenovoRx’s strong intellectual property and regulatory designations, such as FDA Orphan Drug status, provide valuable market exclusivity and protection. These factors enhance RenovoRx’s attractiveness as an investment, indicating substantial growth and potential returns for investors.
Experienced Leadership and Strategic Vision
RenovoRx boasts a seasoned management team with over 200 years of combined experience in drug development and commercialization. The team has a proven track record of successful FDA filings and blockbuster drug launches. Backed by a world-class board of directors and scientific advisors, RenovoRx is strategically positioned to advance its clinical pipeline, expand its innovative TAMP™ platform, and deliver significant value to investors.
Leadership Team
Shaun R. Bagai
Chief Executive Officer
Mr. Bagai has been the Chief Executive Officer and director of RenovoRx since June 2014. Prior to this role, he led Global Market Development at HeartFlow, Inc. from 2011 to 2014, where he directed Japanese market research, regulatory and payer collaboration, and Key Opinion Leader development. At HeartFlow, he orchestrated their largest clinical trial and secured the company's first global customers. Mr. Bagai has a proven track record of launching innovative technologies in both large corporations and growth-phase companies, including developing the European market for renal denervation, which led to Medtronic’s acquisition of Ardian, Inc. in 2011. He holds a BSc. in Biology/Pre-Med from the University of California, Santa Barbara.
Ramtin Agah, MD
Chief Medical Officer, Founder
Dr. Agah has served as Chief Medical Officer and Co-Founder of RenovoRx since December 2009, and as Chairman of the Board since May 2018. He is currently an Interventional Cardiologist at El Camino Hospital, Mountain View, a position he has held since September 2005. Since July 2012, he has also been a physician consultant for Abbott Vascular. Previously, Dr. Agah was an Assistant Professor of Internal Medicine in the Division of Cardiology at the University of Utah. He completed a Fellowship in Interventional Cardiology at the Cleveland Clinic Foundation, a Residency in Internal Medicine at Baylor College of Medicine, and a Fellowship in Cardiology at the University of California, San Francisco. Dr. Agah earned his MD from the University of Texas Southwestern Medical School.
Leesa Gentry
Chief Clinical Officer
Ms. Gentry brings 29 years of experience in improving clinical research programs within the Contract Research Organization (CRO), pharmaceutical, and biotech industries. She has held key positions at IQVIA (Quintiles), PPD, OmnicareCR, and Otsuka. Prior to joining RenovoRx, she was Senior Vice President of Clinical Operations at Evotec (NASDAQ: EVO). At PPD, she served as Global Project Manager and Senior Research Specialist for Clinical Systems, where her team developed one of the pharmaceutical industry’s first clinical trial management systems. At Omnicare, she expanded the clinical research site network within long-term care, with her work being featured in the Good Clinical Practice Journal. During her tenure at Otsuka, she developed novel methods for improved trial implementation in clinical operations, data management, and third-party collaboration, with her work on registration trial implementation in resource-constrained environments being featured in the Bulletin of the World Health Organization. Ms. Gentry holds a B.A. in Psychology and an M.S. in Gerontology from the University of Central Missouri, and an M.A. in Psychology from the University of Mary Hardin-Baylor.
Scientific Advisory Board
Mike Pishvaian, MD, PhD
Associate Professor, Department of Oncology Director of the Gastrointestinal, Developmental Therapeutics, and Clinical Research Programs at the NCR Kimmel Cancer Center at Sibley Memorial Hospital
Johns Hopkins University School of Medicine
Karyn A. Goodman, MD, MS
Professor and Vice Chair of Clinical Research, Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai
Associate Director of Clinical Research, The Tisch Cancer Institute at Mount Sinai
Margaret A. Tempero, M.D.
Professor of Medicine and Director of the UCSF Pancreas Center
Editor-in-Chief of JNCCN
Former ASCO President
Michel Ducreux, M.D., Ph.D.
Head of the Gastrointestinal Oncology Unit and Gastrointestinal Oncology Tumor Board at Gustave Roussy
Professor of Oncology at Paris-Saclay University in France
Vice-Chair of ESMO GI
Sources
- Source 1: https://43577226.fs1.hubspotusercontent-na1.net/hubfs/43577226/RenovoRX%20RNXT%20info%20for%20investors%20May%202024.pdf
- Source 2: https://renovorx.com/about-us/leadership-team/
- Source 3: https://renovorx.com/
- Source 4: https://renovorx.com/about-us/
- Source 5: https://renovorx.com/about-us/advisory-board/
- Source 6: https://renovorx.com/clinical-trials/about-tiger-pac/
- Source 7: https://renovorx.com/tamp/
- Source 8: https://renovorx.com/pipeline-overview/
- Source 9: https://finance.yahoo.com/news/publication-results-pre-clinical-studies-130000365.html
- Source 10: https://finance.yahoo.com/news/renovorx-ceo-shaun-bagai-present-123000434.html
- Source 11: https://finance.yahoo.com/news/renovorx-increases-production-fda-cleared-123000871.html
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