Shots:
- RenovoRx, a clinical-stage life sciences company, is developing targeted oncology therapies and has created RenovoCath, an FDA-cleared novel drug delivery device.
- Its proprietary TAMP therapy platform enables precise delivery of therapeutics across the arterial wall near the tumor site, directly targeting the tumor while potentially reducing the toxicities linked to systemic IV chemotherapy.
- In this discussion with PharmaShots, Shaun Bagai, CEO of RenovoRx, shares insights on the company’s recent patents, ongoing clinical trials, and its upcoming presentation at SSO 2025.
Saurabh: Congratulations on your additional U.S. patent for the Trans-Arterial Micro-Perfusion (TAMP) Therapy Platform issued earlier this Summer. Can you share the details of the patent, such as the purpose of the patent, expiry, and more?
Shaun: Our novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic (intravenous) chemotherapy.
This patent, titled “Methods for Treating Tumors” expands our protection of methods for drug delivery with the TAMP therapy platform, enabled by our proprietary FDA-cleared RenovoCath device. The patent covers new methods for treating solid tumors by delivering drugs locally to a region of an artery or blood vessel that is near the tumor after treating this region to reduce the microvasculature in order to reduce drug washout. The new patent was issued earlier this year and provides protection through November of 2037.
Saurabh: How does this patent strengthen your competitive position, and are you planning to file more patents for this or other products?
Shaun: This patent marks our 9th U.S. and 19th global patent, with 12 additional patents pending, further expanding our growing IP portfolio. This robust IP portfolio is an essential company asset as we advance and scale commercialization of RenovoCath as a stand-alone medical device, with which began generating revenues in December of 2024. We will continue to file additional patents as we further develop and discover the deeper mechanisms of action and how we can further protect this space in addition to patenting future design enhancements to the device.
Since launching our commercial efforts, we have established revenue momentum for RenovoCath, with 13 cancer center customers approved to purchase the device, including several high-volume, National Cancer Institute (NCI)-designated academic and community centers, an increase from five centers in the first quarter of 2025.
Our expanding IP portfolio also protects the assets in our ongoing Phase III clinical trial: the Phase III TIGeR-PaC study is evaluating our investigational drug-device combination product candidate using the TAMP therapy platform enabled by RenovoCath for the intra-arterial administration of chemotherapy (intra-arterial gemcitabine delivered via RenovoCath, known as IAG), versus systemic chemotherapy delivery, for the treatment of locally advanced pancreatic cancer (LAPC).
Saurabh: With patient enrolment well underway and expected to be completed in late 2025/early 2026 for the pivotal Phase III TIGeR-PaC trial in locally advanced pancreatic cancer, can you explain the primary objectives and endpoints of this trial?
Shaun: Systemic chemotherapy is currently the standard of care for pancreatic cancer treatment. However, it is known to cause debilitating side effects for patients diagnosed with this disease. Unlike other tumors with extensive blood supply, pancreatic tumors are hypovascular (have poor blood supply), so systemic chemotherapy may not adequately reach the tumor. Thus, the standard of care may be less effective in treating this type of cancer because the blood vessels are critical for transporting systemic administration of chemotherapy to the tumor.
TIGeR-PaC is an important, ongoing Phase III randomized multi-center clinical trial evaluating our novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG), which uses our proprietary TAMP therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). The trial is comparing treatment with IAG in LAPC to the current standard-of-care (systemic intravenous chemotherapy). The combination product candidate is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA.
Earlier this year, Johns Hopkins Medicine joined a distinguished network of cancer centers across the United States participating in this important trial. Additional sites participating in the pivotal Phase III TIGeR-PaC trial include Northwell Health Cancer Institute in New York, Miami Cancer Institute at Baptist Health South Florida, and West Virginia University Medicine.
The study’s primary endpoint is Overall Survival benefit versus standard of care systemic chemotherapy, the most definitive endpoint, which is extremely impactful. The study also has a number of important secondary endpoints, including side effects and quality of life versus the standard of care.
The current protocol and statistical analysis plan for the Phase III TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of August 12, 2025, 95 patients have been randomized and 61 events have occurred, putting us on target to complete enrollment late this year or early next year.
We are excited to report that the independent Data Monitoring Committee (DMC) for our ongoing Phase III TIGeR-PaC trial recently completed its review of our second pre-planned interim analysis and has recommended that we continue the study. This is great news, as we believe the DMC’s recommendation is an expression of confidence in the potential for a positive outcome in the trial overall.
Saurabh: Data from the recent Society of Surgical Oncology (SSO) 2025 Annual Meeting showed that localized intra-arterial gemcitabine delivered with your TAMP therapy platform reduced systemic toxicity. How could this finding affect current treatment options for pancreatic cancer or even other diseases?
Shaun: Yes, there was exciting preliminary human pharmacokinetic (PK) data presented earlier this year at SSO 2025 supporting our novel TAMP therapy platform, which is part of a sub-study within our ongoing Phase III TIGeR-PaC trial. Final PK data results from this sub-study are being analyzed, and the participating investigators plan to publish these data. TAMP is the key to our Phase III drug-device combination oncology product candidate, IAG, designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tissue, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapies. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Additionally, data presented at SSO 2025 showed that localized, intra-arterial delivery with IAG resulted in lower systemic levels of drug compared to intravenous delivery of gemcitabine.
These findings could potentially set a new bar for the treatment of cancers, not only looking at efficacy but also taking the patient into account. Generally, the focus has been on killing the tumor, and patients’ lives have been severely impacted due to systemic toxicities. While we are already changing the way we look at treating cancer patients, continued positive data from our pivotal Phase III TIGeR-PaC trial could potentially change the standard of care.
Saurabh: Are there plans to expand RenovoRx’s reach internationally and pursue partnerships outside the U.S.?
Shaun: In the future, we would like to expand internationally, as there also exists a high unmet need for adequately and safely treating patients with these types of cancers outside the United States. However, given the large unmet need in the U.S. and local reimbursement tailwinds, we will initially remain focused here for the time being. When the time is right for international expansion in Asia and Europe, we will most likely seek a partner to expand internationally to maintain our low burn rate. We will continue to be opportunistic when it comes to exploring international markets while remaining hyper-focused stateside.
Saurabh: Do you have plans to use the TAMP platform for other cancer types or medical conditions beyond pancreatic cancer?
Shaun: Absolutely. While we are currently focused on pancreatic cancer due to its limited treatment options, we believe we have discovered a better mechanism to broadly treat a variety of tumor types with targeted therapy. Given our successes to date, there has been strong organic inbound interest in exploring additional tumor types that are similar to pancreatic tumors. We recently announced the launch of a post-market registry for the RenovoCath device. This is a solid tumor registry in which we anticipate physicians will explore utilizing our technology with other drugs or agents in additional conditions beyond intra-arterial delivery of gemcitabine to treat locally advanced pancreatic cancer (LAPC).
Specifically, this study, known as PanTheR, is a multi-center, post-marketing observational registry study designed to collect safety information and treatment outcomes for patients who receive oncology treatment for solid tumor cancers using the RenovoCath targeted therapeutic delivery system. PanTheR will capture real-world data on the utilization of RenovoCath and generate additional safety information across a broader range of solid tumors. These data may be used to inform future clinical trial designs.
Several esteemed cancer centers are expected to initiate patient enrollment shortly: the first of multiple is the University of Vermont (UVM) Cancer Center, with Dr. Conor O’Neill, Assistant Professor at the UVM Larner College of Medicine and surgical oncologist, serving as Principal Investigator. From a business standpoint, it is important to note that cancer centers participating in the registry study will purchase RenovoCath devices for use in the study from RenovoRx.
Saurabh: Where would you like to see RenovoRx in the next three years if these current projects and trials are successful?
Shaun: If the current commercial launch of RenovoCath and trials are successful, I would like to see RenovoRx penetrate the pancreatic cancer market and beyond, and drive towards being a highly profitable company. We will have successfully launched our commercial strategy with our RenovoCath device, as well as our TIGeR-PaC Phase III trial and PanTherR registry study. Given the growing space of interventional oncology in large companies, this landscape could also provide us with the optionality of potential inbound interest for acquisition down the road or building a large platform cancer company on our own. If we decide to stay independent, we have the opportunity to expand greatly in the next 3-5 years, and there could be a multi-billion-dollar market opportunity here.
About the Author:
Shaun Bagai
Shaun is a seasoned medical technology leader driven by a passion for transforming patient care through innovation. With global experience spanning both leading corporations and fast-growing technology ventures, he brings a unique blend of strategic vision and hands-on execution. His career journey includes leadership roles in sales, marketing, clinical research, and physician training, equipping him with a 360° perspective on advancing medical technologies from concept to clinical impact.
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