Genenta Advances GBM Treatment by Reprogramming Tumor Microenvironment

Genenta Science, a clinical-stage immuno-oncology firm, has made significant progress in its Phase 1/2 clinical trial for Temferon™, a cell-based therapy for solid tumors. The company has completed dosing of the first patient in Cohort 8, marking the final stage of the dose-ranging phase for newly diagnosed uMGMT Glioblastoma Multiforme (GBM) patients. Preliminary data reveal no dose-limiting toxicities in 22 patients treated so far, with Temferon-derived cells detectable in the bloodstream for over two years post-infusion.

The treatment has shown promising results, with a 2-year Overall Survival (OS) rate of 25% in uMGMT GBM patients, exceeding the historical rate of 14% to 18% for patients receiving standard care. Genenta anticipates releasing top-line Phase 1 data by the end of the second quarter of 2024.

Dr. Luigi Naldini, co-founder of Genenta, highlighted that Temferon has the potential to reprogram the Tumor Microenvironment (TME) and stimulate immune responses against tumors, as supported by RNA single-cell analysis. Carlo Russo, CMO and Head of Development, reported an anecdotal case of a patient surviving over three years with stable tumor conditions, suggesting the therapy's potential in treating a range of solid tumors.

Pierluigi Paracchi, CEO of Genenta, emphasized the technology's ability to prevent systemic toxicity, a common side effect of potent anti-tumor treatments. Temferon is based on ex-vivo gene transfer into autologous Tie2+ hematopoietic stem/progenitor cells, aiming to deliver immunomodulatory molecules directly to tumor-infiltrating monocytes/macrophages.

Genenta is a biotechnology company focused on developing a proprietary hematopoietic stem cell therapy for various solid tumors. Temferon is designed to reach solid tumors, induce a durable immune response, and avoid systemic toxicity, addressing key challenges in immuno-oncology.