NOXXON Pharma N.V. announced that the Data Safety Monitoring Board (DSMB) positively evaluated safety data from the initial four weeks of treatment of the first patient enrolled in the GLORIA clinical trial expansion arm with NOX-A12 combined with radiotherapy and bevacizumab. The DSMB concluded that it is safe and appropriate to continue recruitment of five additional remaining patients into this arm according to the study protocol. NOXXON also announced that the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) approved the third expansion arm of the GLORIA clinical trial in which patients will receive the PD-1 immune checkpoint inhibitor pembrolizumab in combination with NOX-A12 and radiotherapy.

The GLORIA Phase 1/2 clinical trial evaluates the safety and efficacy of NOX-A12 combined with radiotherapy in newly diagnosed brain cancer (glioblastoma) patients with unmethylated MGMT promoter. Three expansion arms, each intending to enrol six patients, will evaluate the benefit of NOX-A12 in other therapeutic settings: Arm A: NOX-A12 with radiotherapy in patients with complete tumor resection - Arm B: NOX-A12 with radiotherapy and bevacizumab in patients with incomplete tumor resection - Arm C: NOX-A12 with radiotherapy and pembrolizumab in patients with incomplete tumor resection.