Genenta Progresses to Higher Dosing Cohort in Temferon™ Phase 1/2a Clinical Trial in Glioblastoma Multiforme

Genenta Science (NASDAQ: GNTA), a clinical-stage biotechnology company pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer, announces that its ongoing trial of Temferon™ in glioblastoma multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM) has escalated to the next planned dose. With no drug-limiting toxicities observed at lower doses, Genenta has now dosed the first patient in a new cohort (cohort 6) with 3.0 x 10⁶ Temferon cells per kilogram, 50% higher than the next highest prior level. One further-escalated dosing level is planned for the Phase 1 segment of the Phase 1/2a trial (cohort 7). Genenta now expects to complete the enrollment and dosing of patients in cohorts 6 and 7 by the end of the first half of 2023.

Pierluigi Paracchi, Chief Executive Officer at Genenta Science, said: “This is a highly important step for Genenta. Temferon has so far been well tolerated without systemic toxicities and has generated positive preliminary signals of immune activity. The data provide preliminary clinical confirmation of Temferon’s mechanism of action. We are now increasing the dose significantly to raise the level of peripheral Temferon cells over time and to help define the optimal dose.”

To date in the Phase 1/2a study, Genenta has dosed Temferon at 0.5, 1.0 and 2.0 x10⁶ cells/kg with no observation of drug-limiting toxicity, and without reaching a maximum tolerated dose. The first part of the ongoing Phase1/2a study aims to define the dose of Temferon that can be administered safely and to assess the therapeutic impact to a range of patients where variability in intrinsic tumor biology, immune status and prior treatments may affect their response to therapy.

The Phase 1/2a study is a multi-center, open-label, dose escalation study in newly diagnosed uMGMT-GBM patients, designed to assess the tolerability, safety and efficacy of Temferon at varying dose levels.