RenovoRx is a life sciences company developing novel targeted oncology therapies based on a local drug-delivery platform for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment.
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 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).
We are actively exploring other commercialization strategies utilizing TAMP technology and RenovoCath as a stand-alone device. The intra-arterial infusion of gemcitabine by RenovoCath is currently under investigation and has not been approved for commercial sale.
RenovoRx is committed to transforming the lives of patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.
Key Highlights
- $1B global market opportunity in the primary indication. Additional financial opportunity for pipeline platform expansion.
- 9 patents issued with 8 pending patents in the US, EU and Asia on TAMP and the proprietary delivery system for targeted combination therapy.
- The first of two interim analyses was completed in March 2023, and the Data Monitoring Committee (DMC) recommended a continuation of the study. The study is prespecified to provide a primary endpoint of a 6-month Overall Survival (OS) benefit and secondary endpoints including reduced adverse events versus standard of care.
- Collaboration with Imugene further validates the TAMP platform and will explore expansion of the pipeline with CF33 oncolytic virus therapy for the treatment of difficult-to-access tumors.