RenovoRx is a clinical-stage biopharmaceutical company developing proprietary targeted combination therapies for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment.
Our proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform is designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic (intravenous (IV) therapy). RenovoRx’s unique approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy. Our Phase III 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 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.
- $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.