RenovoRx Announces Late-Breaking Oral Presentation at 2023 ESMO World Congress on Gastrointestinal Cancer

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today 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 conference will be held June 28 – July 1, 2023, in Barcelona, Spain, with the presentation scheduled for Thursday, June 29, 2023, at 8:50 AM CEST.

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, 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.

"We are thrilled to announce that Dr. Michael J. Pishvaian, Principal Investigator, will present new secondary endpoint data from the interim analysis in our pivotal study at the upcoming ESMO GI,” said Shaun Bagai, CEO, RenovoRx. “This data will notably include PFS from the Phase III study, which has historically been used as a registrational endpoint in FDA New Drug Applications both in accelerated and traditional approvals. We look forward to continued engagement with leading oncologists in the field as we advance RenovoGem and our delivery platform’s potential to benefit cancer patients.”