The Venture Codex

Participated · Equity · May 2018

RenovoRx is a clinical‑stage biopharmaceutical company developing RenovoGem, an oncology drug‑device combination delivered via its proprietary TAMP platform. Its lead program is the pivotal TIGeR‑PaC Phase III study in locally advanced pancreatic cancer, with a primary endpoint of a 6‑month overall survival benefit and secondary endpoints assessing reduced side effects versus standard intravenous chemotherapy. The first interim analysis (26th event) was completed in March 2023 with the Data Monitoring Committee recommending continuation; a second interim analysis is expected at the 52nd event in late 2024. Data from the program have been presented at major oncology meetings, and the company plans a second late‑stage CouGar Phase III study in bile duct cancer. RenovoRx has identified additional potential indications (NSCLC, uterine tumors, glioblastoma, sarcoma) but will require more funding to pursue them. The company says the recent financing bolsters its balance sheet to advance late‑stage programs and reach near‑term clinical milestones. RenovoRx develops the RenovoCath, a dual-balloon infusion catheter designed to isolate blood flow and deliver chemotherapy directly to pancreatic tumors without identifying local blood vessels. The company received FDA clearance for RenovoCath in 2014, a CE Mark in 2015, and expanded FDA labeling in 2017. Based on early feasibility data, the targeted intra-arterial approach suggested an improved survival benefit versus historical controls for locally advanced pancreatic cancer. The FDA granted RenovoCath an Orphan Drug Designation and approved an Investigational New Drug (IND) application enabling the company to proceed directly to a pivotal Phase III study. Enrollment has begun in a randomized Phase III trial comparing intra-arterial chemotherapy via RenovoCath to systemic chemotherapy in ~300 patients at up to 20 U.S. sites, with overall survival as the primary endpoint and safety and quality of life as secondary endpoints. The announced financing will be used to support ongoing product development and these clinical trials. RenovoRx, founded in 2009 and based in San Jose, California, develops novel catheter technologies to deliver fluids to the peripheral vascular system. Its system enables direct, localized delivery of fluids, including radiopaque material and therapeutic agents, to selected sites. The company is led by CEO Marta Gaia Zanchi, COO/CTO Kamran Najmabadi, and CMO Ramtin Agah. In January 2014 RenovoRx closed a $1.15M Series B financing to advance its program. Management says the proceeds will be used to support important milestones and to meet clinical need for its system in 2014. The financing reflects continued investor interest as the company progresses toward clinical objectives.