Genenta Science secures approval for trial for metastatic Renal Cell Cancer

Genenta Science announced that the Agenzia Italiana del Farmaco has approved a new Phase 1 clinical trial for metastatic Renal Cell Cancer, marking a significant expansion of the potential applications for Genenta’s flagship product, Temferon. This approval by AIFA is in line with the standards that are harmonized across European regulatory frameworks established by the European Medicines Agency. Genenta’s ongoing TEM-GBM development program is progressing having completed a Phase 1 dose-ranging trial that confirmed the absence of dose-limiting toxicities across 24 patients. Temferon-derived cells remained detectable in the peripheral blood for over two years post-infusion. The treatment has been associated with a median survival of 16.8 months, showing a 25% increase in the 2 years overall survival, setting the stage for our decision to advance to Phase 2 of the study. Metastatic disease is evident in 25% of newly diagnosed patients with mRCC. The newly approved mRCC trial, expected to commence in Q4 2024, targets a high-risk patient population whose median overall survival is currently less than 2 years after multiple lines of therapy. IFNalpha, the therapeutic payload delivered by Temferon, has demonstrated benefits across a range of solid tumors, including those involving the urinary tract. This trial aims to leverage similar immune response mechanisms against renal cell cancer.