RenovoRx (RNXT) is a life sciences company at the forefront of developing targeted oncology therapies aimed at addressing unmet medical needs in cancer treatment. With its proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform, RenovoRx is committed to improving therapeutic outcomes by delivering cancer treatments directly to tumor sites, minimizing the systemic side effects that often accompany traditional chemotherapy. This innovative approach promises to enhance safety, tolerance, and effectiveness for patients with cancers that are difficult to treat.
About RenovoCath: Precision Drug Delivery for Cancer Treatment
RenovoCath®, RenovoRx’s FDA-cleared drug delivery device, is central to the company’s groundbreaking approach to cancer treatment. This device is designed to isolate blood flow and deliver therapeutic agents precisely to targeted sites within the peripheral vascular system. RenovoCath’s capabilities include:
Blood Flow Isolation and Drug Delivery: Enables the precise administration of diagnostic and therapeutic agents, including chemotherapy, directly to specific sites in the vascular system.
Temporary Vessel Occlusion: Allows temporary occlusion in various procedures, such as arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
Compatibility with Arterial Vessels: Suitable for use in arteries with diameters ranging from 3mm to 11mm.
The RenovoCath device provides a targeted intravascular approach that may reduce the systemic side effects associated with traditional intravenous chemotherapy by focusing treatment on the affected area.
RenovoRx also announced in late September that it would ramp up production of its FDA-cleared RenovoCath catheter-based delivery system, responding to rising demand from oncologists and interventional radiologists for precise, targeted delivery of diagnostic and therapeutic agents. This surge highlights the unique value RenovoCath offers in the treatment of difficult-to-reach tumors, where conventional therapies often fall short.
To support this growth, RenovoRx has solidified its partnership with Medical Murray, a leading manufacturer based in North Barrington, IL. The new project work order with Medical Murray includes a performance-based incentive: a warrant to purchase up to 709,500 shares of RenovoRx stock. These shares will vest only if Medical Murray meets specific manufacturing milestones, underscoring RenovoRx’s commitment to quality and scalability as it explores new commercial applications for RenovoCath beyond current clinical trials.
We announced in our most recent SEC quarterly report that we are actively exploring commercial
opportunities to meet what we see as growing demand for our proprietary RenovoCath technology. Beyond LAPC, we believe there are many clinical applications for RenovoCath to improve targeted delivery of diagnostic and therapeutic agents. Securing the manufacturing capacity for this strategy with our partner Medical Murray is a great first step. We are also in active discussions with many interested customers to purchase supplies of RenovoCath as well as potential distribution partners. When launched, we expect our commercial strategy to accelerate our path to revenue generation, which we hope will occur during 2025.
Shaun Bagai, Chief Executive Officer of RenovoRx
TIGeR-PaC Clinical Trial: Evaluating TAMP for Pancreatic Cancer
The TIGeR-PaC clinical trial is a Phase III, multi-center study evaluating RenovoRx’s proprietary TAMP therapy platform in treating Locally Advanced Pancreatic Cancer (LAPC). This trial uses RenovoRx’s first investigational product, a drug-device combination that combines the RenovoCath® catheter with intra-arterial gemcitabine HCl, a chemotherapy agent, to deliver treatment directly to the tumor site.
Primary Goal: To achieve a 6-month overall survival benefit compared to standard chemotherapy treatments.
Secondary Endpoints: Assessing reductions in side effects relative to traditional systemic treatments.
Interim Results: In March 2023, an initial analysis showed promising results, leading the Data Monitoring Committee to recommend continuing the study. The next interim analysis is expected in late 2024 or early 2025.
This targeted approach seeks to improve outcomes for patients with LAPC, a condition with limited treatment options and poor survival rates.
Unmet Needs in Pancreatic Cancer Treatment: LAPC Focus
Pancreatic cancer remains one of the most challenging and deadly forms of cancer worldwide. With nearly 495,000 new cases each year, the disease is often detected at advanced stages, with 30% of patients presenting with locally advanced pancreatic cancer (LAPC) at diagnosis. In the United States alone, around 62,000 new cases are identified annually, with a staggering 48,000 cancer-related deaths. As a result, pancreatic cancer is on track to become the second leading cause of cancer-related mortality in the U.S., underscoring an urgent need for effective treatments.
Currently, the standard treatment options for LAPC offer limited improvement in survival rates. Patients undergoing chemotherapy with regimens like gemcitabine combined with nab-paclitaxel or mFOLFIRINOX face a median overall survival of just 12 to 18.8 months from diagnosis. Given this bleak prognosis, there is a significant drive within the medical community to discover new, more effective therapies that can extend survival and enhance quality of life for LAPC patients.
Limited Progress with Current FDA-Approved Therapies
In the past decade, only three drugs have received FDA approval to treat LAPC, highlighting the limited advancement in available options for this aggressive cancer. Drugs like Abraxane, Olaparib, and Onivyde have brought some hope, but their benefits in extending survival have been minimal, often under two months of median overall survival benefit.
One notable example is Abraxane, approved by the FDA in 2013, which offered patients only a 7-week median overall survival benefit. Similarly, Olaparib and Onivyde received approvals but have shown negligible improvement in median overall survival, with increased side effects. These drugs are associated with heightened toxicity, leading to serious side effects such as neutropenia (38% Grade 3 or higher) and neuropathy (17%), which can severely impact patients’ quality of life.
Conclusion
RenovoRx (RNXT) presents a compelling investment opportunity with its validated TAMP platform, designed to target large markets with significant unmet needs, such as the $1 billion market for pancreatic cancer treatment. By focusing on de-risked drug development and a scalable platform, RenovoRx is well-positioned for expansion and further commercialization. The company’s FDA-cleared RenovoCath device not only facilitates targeted chemotherapy delivery but also holds potential for broader applications beyond gemcitabine, potentially paving the way for strategic partnerships.
RenovoRx’s Phase III interim analysis in the TIGeR-PaC study demonstrated a promising 6-month overall survival benefit, an 8-month progression-free survival benefit, and a significant reduction in side effects, enhancing its appeal to both patients and investors.
With the stock price holding steady around $1.10 and numerous catalysts on the horizon, keeping RNXT shares could be a savvy investment choice.
