Catalyst Watch: RenovoRx, Inc. Nears June 29th Data Release From Its Phase III TIGeR-PaC Trial Targeting Pancreatic Cancer ($RNXT)

Catalyst Watch: RenovoRx, Inc. Nears June 29th Data Release From Its Phase III TIGeR-PaC Trial Targeting Pancreatic Cancer ($RNXT)

Weakness in RenovoRx, Inc. (NASDAQ: RNXT) shares should be an attraction, not a deterrent. Why? Because the bearish trend is more sector-specific than it is company. In fact, RNXT shares are trading lower despite recent news indicating the company is accelerating its pace of concluding its Phase III TIGeR-PaC clinical trial targeting pancreatic cancer. In June, RNXT announced that the University of Texas (UT) Southwestern Medical Center has been added to the list of sites actively enrolling pancreatic cancer patients in RNXT’s open-label, randomized clinical trial, investigating RenovoGem, which utilizes RenovoRx’s proprietary therapy platform, TAMP™, to provide improved and targeted intra-arterial delivery of FDA-approved gemcitabine chemotherapy to treat Locally Advanced Pancreatic Cancer (LAPC). It’s not a sell-the-news event.

Results, adding to those published, could be transformative. Keep in mind that the study is comparing RenovoGem with the standard-of-care treatment (intravenous gemcitabine and nab-paclitaxel) and can build upon positive interim data analysis that suggested a 6-month improvement in median overall survival and a 65% reduction in side effects versus standard-of-care. That’s excellent news in a market needing better treatments. Pancreatic cancer is expected to be the second largest cause of cancer-related deaths before 2030. And RNXT hopes to show that its treatment method is a better option to the standard of care using systemic, intra-venous chemotherapy utilizing blood vessels to deliver treatment. RNXT’s approach is different, which they believe is its advantage.

Their research shows that pancreatic cancer tumors have a poor blood supply, so systemic chemotherapy may not reach the tumor. Thus, designing a different approach to treatment, RNXT is evaluating targeted, intra-arterial chemotherapy that is singularly focused on the cancer. The addition of UT Southwestern Medical Center is the latest to join in the Phase III effort. And as one of the world’s premier academic medical organizations, integrating research with exceptional clinical care adds plenty of additional research firepower.

A Larger Goal: Enhance Survival And Quality Of Life

In fact, UT Southwestern staff over 2,800 providers responsible for groundbreaking medical advances, committed to translating science-driven research quickly to new clinical treatments. Physicians there provide medical care in about 80 specialties to more than 105,000 hospitalized patients, treat nearly 370,000 emergency room cases, and oversee approximately three million outpatient visits annually. Accurately stated, RNXT has again aligned itself with a partner validating the importance and promise of its treatment candidates.

And the enhanced team is moving the TIGeR-PaC Phase III trial forward. Particulars of the study design include it being a randomized multi-center Phase III open-label clinical trial designed to investigate RNXT’s first product candidate, RenovoGem™. It’s utilizing RenovoRx’s proprietary therapy platform, TAMP™, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT). 

Furthermore, the study compares treatment with TAMP versus standard-of-care systemic intravenous (IV) administration of gemcitabine and nab-paclitaxel to a randomized 114-patient population (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. The final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: the first when 30% of the specified events have been reported and the second when 60% of the events have been reported (expected in mid-2024). 

RenovoGem™ is also being appraised.

RenovoGem™ Can Be A Treatment Game-Changer

RenovoGem™ is the first drug-device combination product candidate that utilizes the TAMP™ 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. In addition to being evaluated in the randomized Phase III TIGeR-PaC clinical trial study, RNXT plans to investigate RenovoGem’s value in extrahepatic Cholangiocarcinoma (eCCA) in a clinical trial expected to start in the first half of 2023. That could be a milestone announcement in the queue.

Additional positive announcements could follow. RNXT announced the acceptance of a late-breaking oral presentation for RenovoGem, in the treatment of locally advanced pancreatic cancer (LAPC) at the ESMO World Congress on Gastrointestinal Cancer (ESMO GI) being held June 28 – July 1, 2023, in Barcelona, Spain. Investors may want to pay attention.

According to RNXT, the presentation will feature new secondary endpoint data from the first interim analysis in the Phase III TIGeR-PaC study. Keep in mind that companies seldom promote bad news. Thus, trading ahead of the data release may be a wise and timely consideration, especially since it’s Phase III. Moreover, it can add to the excellent interim data already published.

Data presented at the recent American Association of Clinical Research (AACR) 2023 conference demonstrated a 6-month median overall survival difference between the test arm (RenovoGem) and control arm (standard of care gemcitabine and Abraxane) along with a 65% reduction in adverse events. The second data set could be better. That’s based on a “read between the lines” statement by RNXT.

In an update, Shaun Bagai, CEO, RenovoRx, said, “We are thrilled to announce that Dr. Michael J. Pishvaian, Principal Investigator, will present new secondary endpoint data from the interim analysis in our pivotal study at the upcoming ESMO GI.” He added, “This data will notably include PFS from the Phase III study, which has historically been used as a registrational endpoint in FDA New Drug Applications both in accelerated and traditional approvals. We look forward to continued engagement with leading oncologists in the field as we advance RenovoGem and our delivery platform’s potential to benefit cancer patients.”

That presentation is on Thursday, June 29. 

Catalyst-Type News Could Be The Queue

Of course, RNXT must deliver as expected, and precedent suggests they can. So far, 47 of 114 target post-SBRT/chemotherapy patients have been randomized in the TIGeR-PaC clinical trial. RNXT has received reports of 26 events in this population. This 26th event represents 30% of the 86 events and thus triggered the first planned interim analysis and a meeting of the study’s Data Monitoring Committee (“DMC”) to evaluate the ongoing progression of the Phase III clinical trial. Upon completion of the analysis and assessment of the data by the DMC, and RenovoRx’s subsequent review of their findings, it will report the results.

Assuming the data posts as expected, the innovative RenovoRx therapy platform would disrupt the current standard of care and cause a potential changing of the guard at the frontline position, usurping big pharma names like Merck (NYSE: MRK) and Incyte (NASDAQ: INCY). RNXT does have an excellent shot of earning that role by advancing a mission to transform oncology therapy, not only through its TIGeR-PaC Phase III study treating pancreatic cancer but also and expanding its clinical pipeline to treat other solid tumors. Progress is being made.

In 2022 and thus far in 2023, RNXT completed an impressive amount of work. In addition to announcing the Initial Results of the Pharmacokinetic Substudy at the 2023 ASCO Gastrointestinal Cancer Symposium, supporting the potential for the RenovoTAMP therapy platform to increase local gemcitabine delivery and decrease the side effects of pancreatic cancer treatment, RNXT earned its eighth U.S. patent extending the intellectual property coverage of the RenovoTAMP therapy platform. In addition, and usually a good predictor of outcomes, four clinical data abstracts were accepted for presentation at the 2023 ASCO Gastrointestinal Cancer Symposium.

That’s not all. 

Set For a Potentially Transformative 2H/2023

RenovoRx also presented its RenovoTAMP therapy platform at the Advanced Interventional Management Symposium and the Symposium on Clinical Interventional Oncology. RNXT also participated in the University of Cambridge Academy of Therapeutic Sciences Gateway to Translation Seminar Series, presented preclinical research data demonstrating potential utility for the treatment of bile duct cancer, and enrolled the initial pancreatic cancer patient in its ongoing TIGeR-PaC clinical trial study at Columbia University’s New York-Presbyterian Hospital Irving Medical Center.

Thus, it’s fair to suggest that the stage is set for a breakout in the back half of this year. And if interim data confirms the already positive results known, in that case, RNXT will be closer to advancing to a frontline position to treat cancers and tumors, bringing an estimated $429 million treatment opportunity by 2029 into its target field. 

All tolled, the next few weeks could be a defining moment in RNXT history. And at current levels, and ahead of potentially transformative news, the RNXT share price may present a valuation disconnect too compelling to ignore. Indeed, if the imminent interim data is positive, current prices are likely a springboard, not a platform.

 

 

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