Genenta Science (NASDAQ: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, is pleased to announce that the Agenzia Italiana del Farmaco (AIFA) has approved a new Phase 1 clinical trial for metastatic Renal Cell Cancer(mRCC), 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 (EMA).
This approval to initiate a Phase 1 trial in metastatic renal cell carcinoma marks another significant milestone for Genenta, leverages the encouraging results from treating Glioblastoma Multiforme (GBM), and underscores our platform’s potential versatility and effectiveness in other solid tumor indications.
Pierluigi Paracchi, CEO and Co-founder of Genenta
Pierluigi Paracchi, CEO and Co-founder of Genenta, also stated: «We believe 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 our uMGMT Glioblastoma Multiforme (TEM-GBM) studies continue to inform and enhance our understanding, demonstrating Temferon’s potential to reprogram the tumor microenvironment and activate the immune system across diverse oncology landscapes».
Clinical Progress
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 hasbeen 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.
IFNα, 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.
Preclinical Update
Prof. Luigi Naldini, Co-founder of Genenta, noted: «Our recent preclinical studies demonstrate synergy between Temferon and other immunotherapy treatments, specifically in the context of solid tumors. This innovative approach leverages Temferon’s ability to reprogram the tumor microenvironment, fostering a cell-mediated immune response».
These findings are pivotal as they lay the groundwork for new therapeutic strategies that could significantly improve outcomes for patients with solid tumors.
Luigi Naldini, Co-founder of Genenta
Genenta will showcase these developments at several upcoming events, including Maxim Group’s 2024 Healthcare Virtual Summit (October 15-17) and at the Society for Neuro-Oncology (SNO) Annual Meeting (November 21-24, Houston, Texas).
About Genenta and Temferon
Genenta is a clinical-stage biotechnology company engaged in the development of a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers.
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 currently under investigation in a clinical trial for newly diagnosed Glioblastoma Multiforme patients with an unmethylated MGMT gene promoter (uMGMT-GBM) and expects to commence a Phase 1 clinical trial for metastatic Renal Cell Carcinoma (mRCC). 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.
