Committed to Transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care.
While the oncology field has made progress with the treatment of cancers over the past few decades, the limited effectiveness of chemotherapy accompanied by debilitating side effects remains a barrier to standard of care treatment. The common objective in chemotherapy treatment innovation is to enhance dosing of the drug, while minimizing systemic toxicity. The standard of care for most cancers is systemic (intravenous) chemotherapy, which delivers chemotherapy throughout the body.
Our proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III lead product candidate is a novel oncology drug-device combination product. It is being investigated under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway.
The investigational drug-device combination candidate utilizes RenovoCath®, the Company’s FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The intra-arterial infusion of gemcitabine by RenovoCath 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).
The TAMP therapy platform is currently being evaluated in the Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC). RenovoRx plans to expand its development pipeline into additional cancer tumors and explore new commercial and clinical business development opportunities with its therapeutic technology. Our oncology drug-device combination product received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon New Drug Application approval.
Indications
Pancreatic Cancer:
According to the American Cancer Society’s Cancer Facts & Figures 2024 and PanCAN, respectively, pancreatic cancer has a 5-year all stages combined relative survival rate of 13% (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 the 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.
RenovoRx received FDA Orphan Drug Designation for the treatment of pancreatic cancer, which will provide the company with seven years of orphan exclusivity, post-approval, to market RenovoGem as a treatment for LAPC upon NDA approval, provided that we are the first sponsor to obtain FDA approval for intra-arterial gemcitabine for the LAPC indication.
Bile Duct Cancer (extrahepatic Cholangiocarcinoma [eCCA]):
RenovoRx plans to study RenovoGem in the Phase III CouGar clinical trial evaluating its second application, bile duct cancer — a rare and aggressive cancer that forms in bile ducts. Bile ducts are thin tubes that carry a digestive fluid, called bile, from your liver to other digestive organs. eCCA starts in the bile ducts outside the liver. Most people with eCCA do not have symptoms until the disease becomes more advanced. For this reason, it is often difficult for clinicians to diagnose the disease early.
RenovoRx has received Orphan Drug Designation for Cholangiocarcinoma, which, if we are the first to obtain FDA approval for intra-arterial gemcitabine for the treatment of eCCA, could provide us with seven years of orphan exclusivity to market RenovoGem for the eCCA indication.
Lung Cancer, Uterine Tumors and Glioblastoma:
RenovoRx plans to launch preclinical studies to explore the application of RenovoGem for the treatment of other solid tumors such as locally advanced lung cancer, uterine tumors, and glioblastoma.