Genenta Science announced 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, the company 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).

The company now expects to complete the enrollment and dosing of patients in cohorts 6 and 7 by the end of the first half of 2023. To date in the Phase 1/2a study, the company 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.