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While the oncology field has made progress with the treatment of cancers over the past few decades, the toxicity limitations of chemotherapy remain a barrier to effective 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 and as a result, often causes debilitating side effects.
RenovoRx’s lead product candidate, RenovoGemTM, a novel oncology drug-device combination product, is being investigated under a US IND that is regulated by FDA 21 CFR 312 pathway. RenovoGem 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.)
RenovoGem utilizes pressure-mediated delivery of gemcitabine across the arterial wall to bathe tumor tissue in chemotherapy. RenovoGem, via the TAMPTM (Trans-Arterial Micro-Perfusion) therapy platform, is currently being evaluated in the Phase III TIGeR-PaC clinical trial in LAPC. RenovoGem will also be evaluated as a potential therapy in bile duct cancer, with a Phase III clinical trial expected to begin in late 2023 with other potential pipeline indication opportunities to follow including non-small cell lung cancer, uterine tumors, glioblastoma, and sarcoma. RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon NDA approval.
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, according to the American Cancer Society’s Cancer Facts & Figures 2023. LAPC is diagnosed when the disease has not spread far beyond pancreas but 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.
* American Cancer Society Facts & Figures 2022