RenovoRx and Imugene Announce Collaboration to Deliver Oncolytic Virus Therapy Using Proprietary Trans-Arterial Micro-Perfusion (TAMP™) Platform

• Collaboration will explore trans-arterial delivery of Imugene’s CF33 oncolytic virus utilizing RenovoRx’s TAMP therapy platform.
• TAMP is expected to enable localized, targeted delivery of CF33 to difficult-to-access tumors, such as pancreatic and liver tumors

RenovoRx, Inc. (“RenovoRx”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, and Imugene Ltd (“Imugene”) (ASX: IMU), a clinical-stage immuno-oncology company, today announced a strategic research collaboration to optimize the delivery of Imugene’s oncolytic virus therapy with RenovoRx’s TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of difficult-to-access tumors.

“We believe the synergy between RenovoRx’s trans-arterial drug delivery system and our CF33 oncolytic virus platform has the potential to facilitate treatment of difficult-to-access cancers and help patients,” said Leslie Chong, Managing Director & Chief Executive Officer of Imugene.

“Our collaboration with Imugene is an important milestone for RenovoRx as we expand our pipeline from exclusively treating locally advanced disease to treating metastatic disease with immunotherapy,” said Shaun Bagai, Chief Executive Officer, RenovoRx. “We look forward to combining our proprietary TAMP platform with Imugene’s CF33 oncolytic virus with the goal of optimizing clinical benefits for patients.”

As part of the collaboration, Imugene and RenovoRx will investigate the ability to administer Imugene’s CF33 oncolytic virus technology with RenovoRx’s TAMP therapy platform. The ability to treat difficult-to-access tumours, such as pancreatic and liver cancers, by delivering CF33 trans-arterially may be valuable to cancer patients compared to traditional administration methods where dense fibrous tissue and lack of blood vessels supplying the tumours have been shown to limit therapy uptake.

The TAMP platform is designed to ensure precise therapeutic delivery to a target tissue. In a study presented at the Society of Interventional Radiology 2019 Annual Meeting, the proprietary platform demonstrated a 100-fold (two orders of magnitude) increase in local tissue concentration with TAMP compared to conventional IV delivery as well as advantages compared to off-the-shelf intra-arterial (IA) delivery. TAMP’s unique approach to treatment delivery offers the potential to increase an oncology therapy’s efficacy, improve safety, and widen its therapeutic window by focusing its distribution uniformly in target tissue.

RenovoRx won the Drug Delivery Technology category of the Fierce Innovation Awards – Life Sciences Edition 2020 for its TAMP therapy platform technology.

About Imugene (ASX: IMU)

Imugene Limited is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. Imugene’s unique platform technologies seek to harness the body’s immune system against tumors, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Imugene’s product pipeline includes multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T’s for solid tumors. Imugene is supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets.

Imugene’s vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Imugene is well funded and resourced, to deliver on its commercial and clinical milestones. Together with leading specialists and medical professionals, Imugene believes its immuno-oncology therapies will become foundation treatments for cancer. Imugene’s goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market.

About RenovoRx, Inc.

RenovoRx is a clinical-stage biopharmaceutical company developing targeted combination therapies for high unmet medical needs. The Company’s proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to bypass traditional systemic delivery methods and ensure precise therapeutic delivery to a target tissue, while minimizing a therapy’s systemic toxicities. RenovoRx’s unique approach to drug-delivery offers the potential for increased treatment safety, tolerance, and wider therapeutic windows. The Company’s lead product candidate, RenovoGem™ combines gemcitabine with the company’s patented delivery system and is regulated by FDA under the IND 21 CFR 312 pathway. RenovoGem is currently in a Phase III clinical trial (TIGeR-PaC) for the treatment of locally advanced pancreatic cancer, where it observed a 6-month median Overall Survival benefit and 65% reduction in adverse events at its interim analysis. 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 the collaboration between RenovoRx and Imugene Limited. 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 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.

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