RenovoRx Phase III Open Label TIGeR-PaC Interim Analysis Shows Promising Data That Support Continued Clinical Investigation of RenovoGemTM as a Treatment Option for Locally Advanced Pancreatic Cancer

Rhea-AI Summary

RenovoRx, Inc. (Nasdaq: RNXT) announced promising interim results from the Phase III TIGeR-PaC clinical trial for its product candidate, RenovoGem, aimed at treating locally advanced pancreatic cancer (LAPC).

The interim analysis indicates a 6-month increase in median overall survival in the RenovoGem group (16 months) compared to standard care (10 months). The trial is randomized, with 114 patients expected, and the current analysis included 45 patients. The Data Monitoring Committee recommends continuing the trial, with full data to be presented at the AACR Annual Meeting on April 17, 2023.

Positive

• Promising interim data shows RenovoGem could improve median overall survival by 6 months in LAPC patients.
• Median overall survival for RenovoGem arm is 16 months compared to 10 months for standard care.
• Continuation of the TIGeR-PaC trial is warranted based on positive interim results.

Negative

• Statistical significance for stopping the study early was not reached (p=0.051).
• Interim analysis comprises only 30% of planned events; future results could vary.

Positive Trend in Median Overall Survival Versus Standard of Care, Warrants Continuation of the Pivotal Trial

Full Data Presentation, April 17, 2023, at the 2023 American Association of Cancer Research (AACR) Annual Meeting

LOS ALTOS, Calif.--(BUSINESS WIRE)-- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, today announced promising interim data in the Phase III open label TIGeR-PaC clinical trial. The study is investigating the Company’s first product candidate, RenovoGem, as a potential treatment option in locally advanced pancreatic cancer (“LAPC”).

The interim analysis suggests a 6-month potential improvement in median overall survival with RenovoGem, pending ongoing clinical investigation. TIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGem, which utilizes RenovoRx’s proprietary therapy platform, RenovoTAMP^®, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat LAPC following stereotactic body radiation therapy (“SBRT”). The study compares treatment with RenovoTAMP versus standard of care systemic intravenous (“IV”) administration of gemcitabine and nab-paclitaxel, which has a seven-week survival benefit and $1 billion addressable market.

This first-of-two interim analyses indicates that the TIGeR-PaC study is on track to demonstrate increased lifespan for patients being treated with RenovoGem for LAPC. Final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: this first analysis with 30% of the specified events (deaths) reported and the second analysis when 60% of the events have been reported (expected in 2024).

In this interim analysis, the control and treatment arms demonstrated divergence in median overall survival for patients. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. The TIGeR-PaC Data Monitoring Committee (“DMC”) met and determined the interim data is promising and warrants continuation of this pivotal trial. As of the date of the analysis, 45 patients from U.S. sites had been randomized in this trial and the survival status of all subjects was used for the analysis.

• 23 patients were randomized to intra-arterial gemcitabine (RenovoGem investigational treatment) arm and 22 to continuation of IV gemcitabine and nab-paclitaxel (control or standard of care) arm. There were an equal number of primary events, 13 in each arm.
• The median overall survival in the IV gemcitabine and nab-paclitaxel control arm was 10 months, versus 16 months in the intra-arterial RenovoGem arm. (NOTE: Both arms’ median overall survival calculations do not include 4 to 5-months of life since diagnosis during the induction chemotherapy and radiation phase of the trial).
• Observed a positive trend in median overall survival by 24-weeks (6-months); in this interim analysis, the statistical significance was not reached to stop the study early (p=0.051).

“We are pleased with the promising readout of our study’s first interim analysis, and we extend our sincere and continued strong appreciation to all the patients, investigators, and team members involved in reaching this important milestone,” said Shaun Bagai, CEO of RenovoRx. “Based on these data, we will continue our ongoing clinical trial to collect more data to support our new drug application. Our team intends to engage further with the FDA to facilitate an expeditious path forward for our treatment platform.”

Bagai added, “Our mission is to transform the current standard of care for patients diagnosed with difficult-to-treat cancers, such as LAPC. The trend has been to layer additional drugs to the current standard of care that can double, triple, or quadruple, drug regimen for these patients. Our vision is to greatly improve existing treatment drugs by focusing on their targeted delivery to tumors, and, ultimately, improve quality of life and survival.”

TIGeR-PaC Principal Investigator, Michael J. Pishvaian, M.D., Ph.D. at Johns Hopkins Medicine, said, “Results from the interim analysis echo those of the Phase I/II and observational studies. The data suggests that RenovoGem has the potential to enhance patient survival. This is important because treatment of locally advanced pancreatic cancer is often limited to systemic, high dose IV chemotherapy treatment, which often comes with debilitating side effects to patients.”

Dr. Pishvaian added, “Importantly, these results provide hope for a potentially improved, compelling new treatment option for this important patient population. If study data continues to trend positive, the RenovoGem platform holds promise for expanding to other indications, including other cancers and/or more advanced stages of cancer.”

Full data from the first interim analysis of the TIGeR-PaC study will be presented at the American Association of Cancer Research (AACR) Annual Meeting, April 17, 2023, in Orlando, Florida.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit https://renovorx.com/clinical-trial/.

About Locally Advanced Pancreatic Cancer (LAPC)

According to American Cancer Society’s Cancer Facts & Figures 2023, pancreatic cancer has a 5-year combined overall survival rate of 12% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond pancreas, however, has advanced to the point where it cannot be surgically removed. LAPC is typically associated with patients in stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system.

About RenovoGem

RenovoGem™ is the first drug-device combination product candidate that utilizes the RenovoTAMP^® therapy platform via pressure-mediated delivery technology to deliver gemcitabine, an FDA-approved chemotherapy, locally across the arterial wall to bathe tumor tissue in the chemotherapy. RenovoGem is currently being evaluated in the Phase III TIGeR-PaC clinical trial study in Locally Advanced Pancreatic Cancer (LAPC) patients. The Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA) in a clinical trial, which is anticipated to begin in the first half of 2023.

About RenovoRx, Inc.

RenovoRx is a clinical-stage biopharmaceutical company with a vision to disrupt the current paradigm of cancer treatment. Our mission is to lead a revolution in oncology therapy by delivering its innovative and targeted intra-arterial (IA) delivery of chemotherapy directly to solid tumors. The proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP^®) therapy platform aims to avoid the harsh side effects typical of the current standard of care, or systemic delivery methods, thus improving patient well-being and, potentially extension of life, so more time may be enjoyed with loved ones. RenovoTAMP utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and clinical use, with the goal of improving their safety, tolerance, and widening their therapeutic window by providing more targeted delivery at the location of the tumor tissue. RenovoRx’s lead product candidate, RenovoGem^TM, is a combination of gemcitabine and its patented delivery system, RenovoCath^®, and is regulated by the FDA as a novel oncology drug product to treat unresectable locally advanced pancreatic cancer (LAPC). RenovoGem is currently being studied in the Phase III TIGeR-PaC clinical trial for the treatment of LAPC.

RenovoRx’s patent portfolio for its therapy platform and product candidates includes eight issued U.S. patents, one issued European patent, and several additional patents pending in the US, EU and Asia. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer (cholangiocarcinoma).

Learn more by visiting the RenovoRx website or following 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, interim analysis, and studies, including anticipated timing, statements regarding the potential or results of RenovoTAMP^®, RenovoCath^® or RenovoGem^TM 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, interim analysis, 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, interim analysis 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230308005211/en/

Investor Contact:

KCSA Strategic Communications

Valter Pinto or Jack Perkins

T: 212-896-1254

renovorx@kcsa.com

Media Contact:

Kevin Knight

T: 214-732-9392

kknightpr@gmail.com

Source: RenovoRx, Inc.

FAQ

What are the latest results from RenovoRx's TIGeR-PaC clinical trial?

The latest interim results suggest a 6-month improvement in median overall survival for RenovoGem in treating LAPC.

When will full data from the TIGeR-PaC trial be presented?

Full data will be presented at the AACR Annual Meeting on April 17, 2023.

What is the significance of the 6-month survival improvement in the trial?

It indicates a potential benefit of RenovoGem over standard treatments for LAPC, which traditionally offers limited survival.

What is the median overall survival for RenovoGem compared to standard care?

The median overall survival for RenovoGem is 16 months, compared to 10 months for standard IV treatments.

What does the continuation of the TIGeR-PaC trial imply for RenovoRx?

It implies confidence in RenovoGem's efficacy, allowing for further data collection to support regulatory applications.