RenovoRx’s TAMP platform significantly increases local tissue concentration of chemotherapy, potentially reducing systemic side effects and enhancing treatment efficacy.
The Phase III TIGeR-PaC clinical trial aims to demonstrate the benefits of RenovoGem, a novel oncology drug-device combination, in treating locally advanced pancreatic cancer.
With $17.2 million raised in 2024, RenovoRx is well-funded to continue its pivotal clinical trials and expand its pipeline into additional cancer indications.
RenovoRx (NASDAQ:RNXT), a pioneering clinical-stage biopharmaceutical company, is poised to transform the landscape of cancer treatment. Driven by a vision to revolutionize oncology therapy, RenovoRx is committed to advancing the frontiers of medicine through its innovative intra-arterial (IA) delivery of chemotherapy, precisely targeting solid tumors. Recently, the company has made significant strides, unveiling a series of impactful updates, including substantial financial milestones and encouraging clinical outcomes.
Introducing RenovoRx: Advancing Precision Oncology
RenovoRx (NASDAQ:RNXT) is a clinical-stage biopharmaceutical company dedicated to developing novel precision oncology therapies. Leveraging a proprietary local drug-delivery platform, RenovoRx addresses high unmet medical needs with the goal of improving therapeutic outcomes for cancer patients. The company’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform is engineered to deliver precise therapeutic doses directly to tumors, potentially reducing the toxicities associated with systemic intravenous therapy.
RenovoRx’s innovative and patented approach promises enhanced safety, better tolerance, and improved efficacy in cancer treatment. The company’s leading Phase III product candidate, RenovoGem, is a novel oncology drug-device combination currently under investigation through a U.S. investigational new drug application, regulated by the FDA’s 21 CFR 312 pathway.
Phase III TIGeR-PaC Clinical Trial: Evaluating TAMP for Pancreatic Cancer
The Phase III TIGeR-PaC clinical trial uses RenovoRx’s innovative TAMP (Trans-Arterial Micro-Perfusion) platform to evaluate RenovoGem for treating locally advanced pancreatic cancer (LAPC). This trial compares trans-arterial delivery of gemcitabine (using TAMP) with systemic IV administration of gemcitabine and nab-paclitaxel following stereotactic body radiation therapy (SBRT).
Designed to include 114 patients (57 per arm), all participants receive induction chemotherapy and SBRT. The primary endpoint is a 6-month overall survival (OS) benefit, with secondary endpoints focusing on reduced side effects.
The first interim analysis, completed in March 2023, led to a recommendation to continue the study. The final analysis will follow 86 events, with the second interim analysis expected in late 2024 at 60% (52 events).
TAMP aims to improve localized chemotherapy delivery, potentially reducing systemic toxicity and enhancing patient outcomes.
RenovoRx’s TAMP Therapy Platform: A Breakthrough in
Recently, the company published pre-clinical studies in the Journal of Vascular Interventional Radiology (JVIR) that demonstrate the efficacy and mechanism of its Trans-Arterial Micro-Perfusion (TAMP) therapy.
Authored by Dr. Khashayar Farsad from Oregon Health and Science University, Dr. Paula M. Novelli from the University of Pittsburgh Hillman Cancer Center, and RenovoRx’s Chief Medical Officer, Dr. Ramtin Agah, the study is accessible here.
Traditionally, chemotherapy for solid tumors is administered intravenously, affecting the entire body and causing adverse side effects. RenovoRx’s TAMP platform aims to change this by delivering chemotherapy directly to the tumor, potentially reducing systemic toxicities. Pre-clinical data showed that TAMP achieved a 100-fold increase in local tissue concentration compared to conventional intravenous (IV) delivery and outperformed other intra-arterial (IA) methods.
“TAMP could provide a valuable treatment option for difficult-to-treat solid tumors. We look forward to the final outcomes of the ongoing Phase III clinical trial to confirm these benefits.”
Dr. Farsad
RenovoRx Secures $17.2 Million to Advance Cancer Therapy Development
With $17.2 million in gross proceeds raised since early 2024, RenovoRx (NASDAQ:RNXT) is well-funded to advance its pivotal Phase III clinical trial and expand its development pipeline into additional cancer indications.
RenovoRx announced early afternoon the closing of a private placement that raised approximately $11.1 million. This follows an earlier fundraising round in January 2024.
Shaun Bagai, CEO of RenovoRx, remarked, “Our recent financing achievements are a critical milestone for RenovoRx. These funds bolster our balance sheet and fuel our progress towards key objectives over the next two years. These include continuing our pivotal Phase III TIGeR-PaC clinical trial for locally advanced pancreatic cancer, expanding our TAMP clinical development pipeline into additional cancer indications, and exploring new commercial business opportunities.”
Bagai added, “We are proud of our achievements and grateful for the support of our investors. With their backing, our team is committed to improving patient outcomes by delivering therapies that could revolutionize cancer care.”
The Critical Landscape of Pancreatic Cancer
Pancreatic cancer is a formidable health challenge worldwide, with an annual incidence of approximately 495,000 new cases. Notably, about 30% of these cases present as locally advanced, complicating treatment efforts and outcomes. This significant percentage underscores the urgent need for effective treatment strategies tailored to advanced stages of the disease.
In the United States alone, pancreatic cancer is on track to become the second leading cause of cancer-related deaths, accounting for an estimated 48,000 deaths each year. This stark statistic highlights the aggressive nature of pancreatic cancer and the critical importance of advancements in medical treatments and early detection methods.
Current Standard of Care and Survival Rates
The current standard of care for pancreatic cancer typically involves chemo-radiation regimens. Treatments commonly include combinations such as gemcitabine with nab-paclitaxel or mFOLFIRINOX. Despite these efforts, the median overall survival from the time of diagnosis ranges from 12 to 18.8 months. These survival rates reflect the aggressive progression of the disease and the limited efficacy of existing treatment protocols in extending patient life significantly.
Geographic Incidence
Pancreatic cancer incidence varies by region, with the United States and Europe reporting substantial numbers of new cases annually. In the U.S., around 62,000 new cases are diagnosed each year, while Europe reports approximately 58,007 diagnoses annually.
Conclusion: The Financially Backed Promise of RenovoRx in Oncology
RenovoRx (NASDAQ:RNXT) stands at the forefront of cancer treatment innovation with its precision oncology therapies. Leveraging its proprietary Trans-Arterial Micro-Perfusion (TAMP) platform, the company is dedicated to improving therapeutic outcomes by delivering targeted chemotherapy directly to tumors, thereby minimizing systemic toxicities.
The ongoing Phase III TIGeR-PaC clinical trial is crucial in validating the benefits of RenovoGem, RenovoRx’s novel oncology drug-device combination. This trial aims to improve overall survival rates for patients with locally advanced pancreatic cancer compared to the current standard of systemic chemotherapy.
Financially, RenovoRx is well-positioned to continue its innovative work in oncology. The company has raised $17.2 million in early 2024, including $11.1 million from a recent private placement and an earlier round in January. This robust financial backing supports the pivotal Phase III clinical trial and allows for the expansion of RenovoRx’s development pipeline into additional cancer indications.
