RenovoRx Expands IP Portfolio for Novel Drug-Delivery Platform
RenovoRx, Inc. (Nasdaq: RNXT), a life sciences company focused on developing targeted oncology therapies and commercializing the FDA-cleared RenovoCath® delivery system, today emphasized its robust intellectual property (IP) portfolio. The company is advancing its commercial plans and clinical trials for 2025, leveraging its innovative Trans-Arterial Micro-Perfusion (TAMP) therapy platform.
Earlier this year, RenovoRx expanded its intellectual property (IP) portfolio by publishing an international patent application for its TAMP therapy platform. The company’s IP portfolio is already strong, with 8 issued and 6 pending U.S. patents and 10 issued and 7 pending patents internationally.
The newly published international patent application, WO2024102497, details methods and tools for delivering treatments such as antibodies, nanoparticles, or charged molecules directly to specific tissues. This process utilizes the vasa vasorum, the micro-vessels that supply the outer walls of larger blood vessels near the targeted tissue. This innovation provides a novel approach for targeting and delivering cancer treatments to local tissue, offering a potential improvement over the current standard of care, which is systemic intravenous (IV) therapy.
Dr. Ramtin Agah, Chief Medical Officer and Founder of RenovoRx, commented, “Delivering therapeutics through micro-vessels around the artery via our novel Trans-Arterial Micro-Perfusion technique is central to our treatment paradigm and value proposition. We already hold strong IP protection for our technology, and our 2024 pending patent further describes and seeks protection for the novelty of our approach.”
The TAMP platform aims to ensure the precise delivery of therapeutics across the arterial wall to target tumor sites, potentially reducing the toxicities associated with systemic IV therapy. This targeted approach could lead to improved safety, better patient tolerance, and enhanced efficacy, making it a promising alternative to conventional treatments.
Shaun Bagai, CEO of RenovoRx, highlighted the significance of the company’s growing IP portfolio as it advances toward 2025. “As we move forward with our commercial plans for RenovoCath and the progression of our pivotal Phase III TIGeR-PaC clinical trial, both of which are driven by TAMP, it is important to emphasize the strong IP foundation we have and continue to build. The new patent application filed earlier this year will further enhance the value TAMP offers the oncology community as an innovative and effective drug delivery approach,” Bagai explained. He added that once approved, this patent would extend the company’s IP coverage, increasing the commercial value of both TAMP and RenovoCath.
RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial is evaluating its first product candidate, a novel investigational oncology drug-device combination. This product uses the FDA-cleared RenovoCath device for intra-arterial administration of gemcitabine, a chemotherapy drug, via the TAMP platform. The trial is currently in its second interim analysis phase, with patient enrollment expected to be completed by mid-2025.
In addition to its clinical advancements, RenovoRx has made strides in commercialization by receiving its first purchase orders for RenovoCath devices. This marks a key milestone in the company’s efforts to commercialize the RenovoCath as a standalone device, which can be used by doctors in accordance with its FDA-cleared instructions for use. RenovoCath, powered by the TAMP technology, provides a targeted, effective solution for local drug delivery.
About RenovoCath
RenovoCath® is a device cleared by the FDA for the isolation of blood flow and the delivery of fluids, including diagnostic and therapeutic agents, to selected sites in the peripheral vascular system. It is also indicated for temporary vessel occlusion in applications such as arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
About the TIGeR-PaC Clinical Trial
The TIGeR-PaC trial is an ongoing Phase III randomized, multi-center study evaluating the TAMP™ therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC). RenovoRx is investigating its first product candidate, a combination of the RenovoCath device and gemcitabine, for intra-arterial administration as part of the study. The primary endpoint of the trial is overall survival, with secondary endpoints focusing on reduced side effects compared to standard treatment.
The study’s first interim analysis, completed in March 2023, recommended continuing the trial. The second interim analysis will occur when the 52nd patient event is recorded, which is expected to happen in late 2024 or early 2025. RenovoRx aims to complete patient enrollment for the trial by mid-2025.
About RenovoRx, Inc.
RenovoRx is committed to advancing novel, targeted oncology therapies and commercializing its FDA-cleared RenovoCath® drug-delivery system. The company’s TAMP™ platform enables precise therapeutic delivery, targeting tumors while minimizing the systemic toxicities of traditional IV therapies. RenovoRx’s mission is to transform cancer treatment by offering innovative solutions for the targeted delivery of diagnostic and therapeutic agents, improving the safety, efficacy, and overall experience for patients.
RenovoRx’s Phase III clinical trial is investigating its drug-device combination for the treatment of LAPC. The combination utilizes RenovoCath® for intra-arterial infusion of gemcitabine, which is currently being evaluated under the FDA’s investigational new drug pathway. This approach has received Orphan Drug Designation, providing the potential for seven years of market exclusivity upon FDA approval. RenovoRx is also exploring other commercialization strategies using the TAMP technology and RenovoCath system.
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