Rome, 4 October – Genenta, an Italian biotech company listed on Nasdaq that is developing gene therapies against solid tumors, announced that Aifa, the Italian Medicines Agency, has approved a new Phase 1 clinical trial for metastatic renal cell carcinoma (mRCC ), marking a significant expansion of potential applications for the company’s flagship product, Temferon. This approval by AIFA, we read in a note issued by Genenta, is in line with the standards harmonized in the European regulatory frameworks established by the EMA, the European agency.
“This approvation to initiate a Phase 1 trial in metastatic renal cell carcinoma marks another significant milestone for Genenta, builds on encouraging results in the treatment of glioblastoma multiforme (GBM), and highlights the potential versatility and efficacy of our platform in other solid tumor indications ” is the comment of Pierluigi Paracchi, CEO and co-founder of Genenta.
“Our recent preclinical studies demonstrate the synergy between Temferon e other immunotherapy treatments, particularly in the context of solid tumors” he adds Luigi Naldini (in the photo)director of the San Raffaele Telethon Institute for Gene Therapy (Tiget SR) and professor at the Vita-Salute San Raffaele University of Milan, co-founder of Genenta with Paracchi and the German specialist Bernhard Gentnerdoctorates at the Ruprecht-Karls-Universität in Heidelberg and at the Baylor College of Medicine in Houston and a post-doc in Italy at the Tiget del San Raffaele, where he is currently head of the translational research unit on stem cells and leukemia. “This innovative approach leverages the ability of Temferon to reprogram the tumor microenvironment” Naldini explains further “promoting a cell-mediated immune response. These findings are critical as they lay the foundation for new therapeutic strategies that could significantly improve outcomes for patients with solid tumors.”.
