Genenta Science (NASDAQ: GNTA) has announced that the Agenzia Italiana del Farmaco (AIFA) has approved a Phase 1 clinical trial for its flagship product, Temferon™, in metastatic Renal Cell Cancer (mRCC). This approval marks a significant expansion of Temferon's potential applications beyond Glioblastoma Multiforme (GBM) and aligns with the standards established by the European Medicines Agency (EMA).
The Phase 1 trial is set to commence in Q4 2024 and will focus on patients with high-risk mRCC who have a median overall survival of less than two years following multiple lines of therapy. Metastatic disease is evident in 25% of newly diagnosed patients with mRCC. Temferon delivers IFNα, a therapeutic payload that has shown benefits across a range of solid tumors, including those involving the urinary tract.
Clinical Progress in Glioblastoma Multiforme
Genenta's ongoing TEM-GBM development program has completed a Phase 1 dose-ranging trial, which confirmed the absence of dose-limiting toxicities across 24 patients. Notably, Temferon-derived cells remained detectable in the peripheral blood for over two years post-infusion. The treatment was associated with a median survival of 16.8 months, with a 25% increase in the 2-year overall survival rate, paving the way for a Phase 2 study.
Preclinical Evidence of Synergy
According to Prof. Luigi Naldini, Co-founder of Genenta, preclinical studies have demonstrated a synergy between Temferon and other immunotherapy treatments, particularly in solid tumors. This synergy leverages Temferon's ability to reprogram the tumor microenvironment, fostering a cell-mediated immune response. These findings are pivotal for developing new therapeutic strategies to improve outcomes for patients with solid tumors.
Management Commentary
Pierluigi Paracchi, CEO and Co-founder of Genenta, stated that the approval to initiate a Phase 1 trial in metastatic renal cell carcinoma marks another significant milestone for Genenta. He added that it leverages the encouraging results from treating Glioblastoma Multiforme (GBM) and underscores the platform’s potential versatility and effectiveness in other solid tumor indications. Paracchi believes Temferon will offer a new experimental treatment to patients with late-stage mRCC, a patient population with no currently available treatment options. The insights gained from uMGMT Glioblastoma Multiforme (TEM-GBM) studies continue to inform and enhance the understanding, demonstrating Temferon's potential to reprogram the tumor microenvironment and activate the immune system across diverse oncology landscapes.
Mechanism of Action
Temferon™ is based on ex-vivo gene transfer into autologous Tie2+ hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). Temferon is designed to reach solid tumors, induce a durable immune response not restricted to pre-selected tumor antigens nor type, and avoid systemic toxicity, which are some of the main unresolved challenges in immuno-oncology.
