Genenta Science announces follow-up observations in glioblastoma study

Genenta Science (GNTA) announced that a total of 38 patients were enrolled in newly diagnosed glioblastoma multiforme study, with 25 patients receiving Temferon. Two patients have been enrolled in the TEM-LT long-term follow-up study, surviving three years from the time of 1st surgery. One of these long-term survivors has not experienced disease progression following Temferon administration and has not required any second-line therapies. The other showed initial signs of disease progression that subsequently stabilized without additional therapeutic intervention. Both these cases suggest possible Temferon-mediated control of disease progression, which warrants further investigation in larger studies. As of the April data cutoff, the survival rate at two years in the GBM trial for unmethylated MGMT patients remained consistent at 29% with median overall survival holding steady at 17 months. In historical cohorts, uMGMT patients receiving standard of care have shown a two-year survival rate of approximately 14% and a median overall survival of 13 to 15 months. In parallel, the TEM-GU Phase 1 study-designed to enroll 12 patients with genitourinary tumors-has begun recruitment. In this trial, Temferon is administered at a fixed dose of 4M genetically modified cells per kilogram of body weight-a level previously shown to be safe and well tolerated in the TEM-GBM dose-ranging study. Genenta aims to demonstrate the safety and tolerability of Temferon in patients with Metastatic Renal Cell Carcinoma by year-end. The study is designed to evaluate Temferon in combination with immune checkpoint inhibitors or tyrosine kinase inhibitors to assess the potential for immunologic synergy in this patient population. Further clinical updates will be shared once sufficient patient experience has been gained to support meaningful interpretation. Temferon’s mechanism of action is based on the reprogramming of the tumor microenvironment, which promotes the activation and durability of adaptive immune responses. A scientific manuscript demonstrating Temferon’s potential to enhance and prolong the durability of CAR-T activity in preclinical murine models of solid tumors has been accepted for publication in Science Translational Medicine.