RenovoRx, Inc. announced the acceptance of a late-breaking oral presentation for its lead product candidate RenovoGem, in the treatment of locally advanced pancreatic cancer (LAPC), at the upcoming ESMO World Congress on Gastrointestinal Cancer (ESMO GI). The presentation will feature new secondary endpoint data from the first interim analysis triggered in the Phase III TIGeR-PaC study - a multi-center, open-label clinical trial. The study is evaluating RenovoGem to treat LAPC through RenovoRx's proprietary trans-arterial micro-perfusion (TAMP™?) drug-delivery platform of FDA-approved gemcitabine.

The Phase III study has a primary endpoint of overall survival and several secondary endpoints, including progression-free survival (PFS) and quality of life. The study is designed to randomize 114 patients. Final analysis will be conducted after 86 events (deaths) from the stereotactic body radiation therapy (SBRT) population.

The study includes two planned interim analyses, the first upon 30% (26 of 86) of total events and the second upon 60% (52 of 86) of total events. Data from the planned first interim analysis of the Phase III TIGeR-PaC study, presented at recent American Association of Clinical Research (AACR) 2023 [2], demonstrated a 6-month median overall survival difference between the test arm (RenovoGem) and control arm (standard of care gemcitabine and Abraxane) along with a 65% reduction in adverse events. Abstract Title: “The Phase 3 study Targeted Intra-Arterial Gemcitabine vs.

Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with Sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer (TIGeR-PaC) trend toward a survival benefit at its first interim analysis”. Presenting Author: Michael Jon Pishvaian, M.D., Ph.D.,Director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs, Associate Professor of Oncology, John Hopkins School of Public Health Presentation Date and Time: June 29, 2023, at 8:50 – 9:00 AM CEST. The treatment of LAPC remains a clinical challenge with a median survival of 15-18 months from diagnosis.

RenovoGem™ delivers gemcitabine directly to the tumor site, enhancing the therapeutic effectiveness while potentially minimizing the systemic side effects commonly associated with traditional chemotherapy intravenous administration, and potentially improving patient outcomes. RenovoGem is currently under investigation for the intra-arterial delivery of gemcitabine and has not been approved for commercial sale.