RenovoRx Files New International Patent for Novel Targeted Combination Drug-Delivery Oncology Therapy Platform

RenovoRx Holds a Strong Intellectual Property (IP) Portfolio with 9 Issued Patents for its Proprietary Trans-Arterial Micro-Perfusion (TAMP™) Therapy Platform and Delivery System

New Patent Would Expand IP Coverage for TAMP to Deliver Additional Therapeutic Classes Across DNA/RNA Altering Modalities, Cell Therapy, and Antibody-Based Therapies

RenovoRx, Inc. (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, announced today that the Company has filed an international patent application under the Patent Cooperation Treaty (PCT) for its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform. The Company already holds a strong intellectual property portfolio with 9 issued patents and 9 pending patents for its proprietary TAMP platform and delivery system in the US, EU, and Asia. The patent portfolio covers two main areas, mechanical and biological.

The new international patent application is filed under the Patent Cooperation Treaty on methods and apparatuses that may be used to deliver one or more therapeutic agents through the vaso vasorum (small blood vessels that supply the walls of larger arteries or veins) to a target tissue. RenovoRx believes that these methods and apparatuses via the TAMP therapy platform may provide a novel and important pathway for the targeted delivery of therapeutic classes across DNA/RNA-altering modalities, cell therapy, oncolytic viruses, bi-specific antibodies, and monoclonal antibodies for the treatment of a variety of clinical indications. The Company anticipates that the patent application will be published in May of 2024.

"This patent application further expands the value of TAMP into the delivery of larger therapeutic assets, as a unique platform in oncology, beyond our current Phase III clinical asset," said Shaun Bagai, CEO, RenovoRx. "Once approved, it will further extend our IP coverage, opening up new market potential, expanding the upside value proposition of TAMP commercially. We look forward to providing further highlights and updates related to this patent, as well as our progress in our Phase III TIGeR-PaC clinical program."

TAMP is being investigated in the Company’s Phase III TIGeR-PaC clinical trial, an ongoing randomized multi-center study. The study is evaluating trans-arterial delivery of an FDA-approved chemotherapy, gemcitabine, to treat Locally Advanced Pancreatic Cancer (LAPC) following stereotactic body radiation therapy (SBRT). The study is comparing treatment of gemcitabine with TAMP versus systemic IV administration of gemcitabine and nab-paclitaxel.

The first of two interim analyses was completed in March 2023, and the Data Monitoring Committee (DMC) recommended a continuation of the study. The study is prespecified to provide a primary endpoint of a 6-month Overall Survival benefit and secondary endpoints including reduced side effects versus standard of care.

About RenovoRx, Inc.

RenovoRx is a clinical-stage biopharmaceutical company developing proprietary targeted combination therapies for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. The Company’s proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic (intravenous (IV) therapy). RenovoRx’s unique approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate, RenovoGem™, a novel oncology drug-device combination product, is being investigated under a US IND that is regulated by FDA 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of locally advanced pancreatic cancer (LAPC) by the Center for Drug Evaluation and Research (the drug division of FDA.)

RenovoRx is committed to transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale.

For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and Twitter.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding our clinical trials and studies, including anticipated timing, statements regarding the potential of RenovoCath^®, RenovoGem™ or TAMP™ or regarding our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and our preliminary financial results, cash position and related ability to continue as a going concern. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, clinical trials, therapy platform, business plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “estimates,” “intends,” and “potential,” or the negative of these terms or other comparable terminology regarding RenovoRx’s expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; the possibility that interim results may not be predictive of the outcome of our clinical trial, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, or the regulatory authority may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercialization potential of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; negative impacts of the ongoing COVID-19 pandemic on our operations; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission.

Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231213583366/en/