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Abstract
Temferon is an ex vivo gene therapy consisting of autologous Hematopoietic Stem Progenitor Cells (HSPCs) genetically modified with a lentiviral vector to deliver IFN-α2 within the tumor microenvironment by Tie-2 expressing macrophages. TEM-GBM is an open-label, Phase I / IIa dose-escalation study evaluating safety and efficacy of Temferon in up to 27 newly diagnosed GBM patients with unmethylated MGMT (uMGMT). As of 30th April 2023, 19 GBM patients in 4 cohorts received incremental doses of Temferon and four are still alive after a median follow-up of 15 months. Six of the treated patients underwent a second surgical intervention at a median of 11 months after 1st surgery. For all patients, median overall survival (OS) and median progression free survival following first surgery reach 15 months and 9.8 months from diagnosis, respectively. The interim survival rate at 2 years in Temferon-treated patients is 28% (5 of 18 patients; 1 patient excluded as follow-up is below 1 year). OS and survival rate at 2 years of uMGMT patients treated as per the current standard of care (SOC) is 12.7 months and 14,8% respectively. One out of the surviving patients is alive 3 years after first surgery without second line therapy added up to 2 years. The other four patients with 2 year follow-up were treated with Gamma-Knife followed by bevacizumab (n = 1), regorafenib followed by bevacizumab (n = 1) and bevacizumab only (n = 2). Bevacizumab administration started 12 months after 1st surgery for one patient and 19 months for the other 2 patients at 5 mg/kg. These data corroborate the initial evidence on safety and tolerability of Temferon. They also suggest that Temferon has potential to counteract disease progression in patients affected by uMGMT GBM.