Genenta Secures Approval for Innovative Trial for Metastatic Renal Cell Cancer

Core Insights - Genenta Science has received approval from the Agenzia Italiana del Farmaco (AIFA) for a new Phase 1 clinical trial targeting metastatic Renal Cell Cancer (mRCC), expanding the applications of its product Temferon™ [1][2] - The trial is set to begin in Q4 2024 and aims to address a high-risk patient population with limited treatment options, where the median overall survival is currently less than 2 years [3] Company Overview - Genenta is a clinical-stage biotechnology company focused on developing proprietary hematopoietic stem cell therapies for various solid tumor cancers, with Temferon designed to deliver immunomodulatory molecules directly to tumors [5] - Temferon is currently under investigation for newly diagnosed Glioblastoma Multiforme patients and is expected to commence a Phase 1 clinical trial for mRCC [5] Clinical Progress - The ongoing TEM-GBM development program has completed a Phase 1 dose-ranging trial with 24 patients, showing no dose-limiting toxicities and a median survival of 16.8 months, which is a 25% increase in overall survival over two years [2][3] - Temferon-derived cells were detectable in the peripheral blood for over two years post-infusion, indicating a durable response [2] Preclinical Insights - Recent preclinical studies indicate that Temferon shows synergy with other immunotherapy treatments, enhancing the immune response in solid tumors [4] Upcoming Engagements - Genenta plans to present its developments at the Maxim Group's 2024 Healthcare Virtual Summit from October 15-17 and at the Society for Neuro-Oncology Annual Meeting from November 21-24 in Houston, Texas [4]