On December 30, 2024 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared delivery system, reported its strong intellectual property (IP) position as it moves forward with commercial plans and clinical trial advancement in 2025, utilizing its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform (Press release, Renovorx, DEC 30, 2024, View Source [SID1234649365]).

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Earlier this year, RenovoRx published a new international patent application for its TAMP therapy platform to expand its IP portfolio. RenovoRx already holds strong IP including coverage of its proprietary TAMP therapy platform and RenovoCath delivery system, with 8 issued and 6 pending U.S. patents, and 10 issued and 7 pending patents outside of the US, including its international application published in 2024.

The new published international patent application WO2024102497 describes methods and tools for delivering treatments (including antibodies, nanoparticles, or charged molecules) directly to specific tissues. This is accomplished using micro-vessels (called the vasa vasorum) that supply the outer walls of larger blood vessels near the specific target tissue to be treated. This invention opens innovative and effective ways to target and deliver cancer treatments in local tissue beyond the current standard-of-care, systemic (intravenous "IV") treatment.

"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," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "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."

TAMP is designed to ensure precise 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 therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.

"As we move forward in 2025 with our commercial plans for RenovoCath and the advancement of our pivotal Phase III TIGeR-PaC clinical trial, both of which are driven by TAMP, it is important to highlight the strong IP foundation we have and continue to expand. The new patent application filed earlier this year would further the value that TAMP can offer the oncology community as an innovative and effective approach to drug delivery," said Shaun Bagai, CEO, RenovoRx. "Once approved, it will incrementally extend our IP coverage and increase the commercial value proposition for both TAMP and RenovoCath."

RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial is evaluating its first product candidate, a novel investigational oncology drug-device combination utilizing the FDA-cleared RenovoCath device via TAMP for the intra-arterial administration of the chemotherapy gemcitabine. RenovoRx currently anticipates completion of both patient enrollment and the second interim analysis for TIGeR-PaC by the end of the first half of 2025.

Moreover, RenovoRx recently announced the receipt of its first purchase orders for RenovoCath devices. This milestone marks a positive continuation of RenovoRx’s previously announced efforts to commercialize RenovoCath as a standalone device to be used by doctors in accordance with its FDA-cleared instructions for use. RenovoCath is powered by TAMP.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx’s first product candidate using the TAMP technology, is a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy, gemcitabine.

The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The study’s primary endpoint is an Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event (i.e., patient death), which is estimated to occur in late 2024 or early 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025.