Genenta Science, a clinical-stage biotech firm specializing in immuno-oncology, has made significant progress in its Phase 1/2 clinical trial for Temferon™, a cell-based therapy targeting solid tumors. The company has completed dosing for the first patient in Cohort 8, marking the final stage of the dose-ranging portion of the trial for patients with newly diagnosed uMGMT Glioblastoma Multiforme (GBM). So far, no dose-limiting toxicities have been observed in the 22 patients treated, and Temferon-derived cells have been detected in the bloodstream for over two years post-infusion.
Preliminary results for uMGMT patients, the most aggressive form of GBM, show a 2-year Overall Survival rate of 25%, surpassing the historical rate of 14% to 18% for patients receiving standard care. Genenta anticipates releasing the primary Phase 1 data by mid-2024.
Dr. Luigi Naldini, a co-founder of Genenta, suggests that Temferon has the potential to reprogram the Tumor Microenvironment and activate immune responses. Carlo Russo, the company's CMO, highlighted a patient who survived over three years with the treatment, indicating its potential for various solid tumors. Pierluigi Paracchi, CEO of Genenta, emphasized the technology's ability to prevent systemic toxicity.
Temferon is based on gene transfer into autologous hematopoietic stem/progenitor cells to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages. It is designed to induce a durable immune response and avoid systemic toxicity, addressing key challenges in immuno-oncology.
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