On January 7, 2022 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported 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 (Press release, NOXXON, JAN 7, 2022, View Source [SID1234598421]). 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.
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Aram Mangasarian, CEO of NOXXON, commented: "The three arms in the expansion of our Phase 1/2 study of NOX-A12 are supported by the clinical data from the GLORIA trial and are designed to explore the potential for improved benefits for patients with brain tumors. The combination with the anti-PD-1 inhibitor pembrolizumab is of particular interest as we expect this combination therapy to unlock a stronger and more durable immune response against the tumor. This is based on our previous observation that NOX-A12 drives infiltration of activated cytotoxic immune cells into brain tumor tissue. We plan to use clinical data from the expansion arms to support our future pivotal glioblastoma study."
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.