RenovoRx (NASDAQ: RNXT) is a California-based biopharmaceutical company using targeted chemotherapy to treat difficult-to-reach tumors. The company has had several opportunities in the past year to present at investor conferences and is in the process of developing a therapeutic platform that will help eliminate cancerous tumors more safely and accurately. Shaun Bagai, CEO of RenovoRx gives us a look at how the company came to be and what its future looks like as these developments advance.
Q: What can you tell us about RenovoRx?
A: RenovoRx (NASDAQ: RNXT) is a clinical stage company. Our lead product candidate, RenovoGemTM is in a Phase 3 clinical trial. RenovoGem is a combination of intra-arterial gemcitabine, an approved chemotherapy, and our patented delivery system, RenovoCath®.
We have developed a therapy platform, RenovoRx Trans-Arterial Micro-Perfusion, or RenovoTAMPTM, that forms the foundation for RenovoGem. The goal of our therapy is to increase the efficacy, safety, and widen the therapeutic window of anti-cancer drugs (approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles). The FDA has determined RenovoGem will be regulated as a new oncology drug product, which is important since we have also secured Orphan Drug Designation for RenovoGem for the treatment of both pancreatic cancer and, a second planned indication, bile duct cancer. Orphan Drug Designation provides RenovoRx with seven years of exclusivity from approval to market intra-arterial use of gemcitabine in each of these indications.
Our Phase 3 trial, called TIGeR-PaC, is for the treatment of pancreatic cancer with an overall survival primary endpoint and several secondary endpoints including quality of life. We began with pancreatic cancer, which often presents itself at a later stage because it is not easily detected and is often not responsive to systemic chemotherapy.
Our second target indication is bile duct cancer, which forms in the thin tubes (ducts) that go from the liver to the small intestine. This is another cancer that is challenging to treat, and we believe our therapy platform, RenovoTAMP, is poised to help by localizing chemotherapy to the bile duct tumor. There are many other cancers that RenovoTAMP may be used to treat, and our team is committed to advancing our pipeline and helping patients who are battling these difficult to treat cancers.
Q: Tell us about your business endeavors throughout your career, and how you arrived at RNXT?
A: I have been in the medical technology field my entire career – the simplicity, creativity and innovation that drive this field are truly inspiring. It is remarkable to see the products that are born when medicine and innovation come together to solve a problem. If you have ever had a loved one with cancer, you know what it means to fight every day - to fight both the disease and the side effects of the drugs that are battling the disease. I was drawn to RenovoRx by the potential to change the course of cancer treatment and improve outcomes for patients – the potential to make the fight just a little bit easier.
Our therapy platform, RenovoTAMP, was designed by our founders, a physician and an engineer, to take gemcitabine, a drug that works to kill cancer cells, and potentially improve its safety and efficacy. Our first and lead drug candidate is RenovoGem, which is a combination of gemcitabine and our FDA cleared delivery system. For most cancer patients, treatment protocols inevitably involve some form of radiation and/or intravenous chemotherapy which often cause harsh side effects that not only impact the entire body but also can erode quality of life. Our goal is to isolate the tumor and bathe it in chemotherapy using RenovoGem, rather than deliver chemotherapy through the entire body. In our foundational clinical trials, we found that this approach minimizes the typical chemo side-effects, and patients on our therapy were better able to return to their daily activities and most importantly, continue to enjoy time with their families.
Q: Can you explain the limitations of intravenous systemic chemotherapy in the treatment of pancreatic cancer and how RenovoRx’s therapy platform, RenovoTAMP, addresses those issues?
A: There are two critical factors that impact the effectiveness of chemotherapy on pancreatic tumors: its limited penetration of the pancreatic tumor and its systemic side effects. What do I mean by limited penetration? We know that gemcitabine is highly effective when a tumor has what are called “tumor feeders,” which are blood vessels going directly to the tumor. Intravenous systemic chemo administration flows throughout the patient’s body and can use tumor feeders to access the tumor. Of course, this comes with systemic side effects because the chemo is accessing the entire body for its delivery. Pancreatic tumors are different – they lack tumor feeders, so traditional delivery of chemo is simply not as effective. Using the RenovoTAMP therapy platform, we can overcome this barrier by identifying a blood vessel that is near the tumor and then delivering chemotherapy intra-arterially – or through the blood vessel wall – directly to the tumor itself. Our foundational clinical trials with RenovoTAMP provide evidence that intra-arterial, targeted delivery of chemotherapy not only reduces the side effects of chemo, it also can improve quality of life and extend the time that our patients have with their families. That we have the potential to make a treatment more effective, decrease its side effects and give pancreatic cancer patients another option to fight this deadly disease is meaningful. It is what drives our team at RenovoRx to do the work we are doing.