The move comes after the Data Safety Monitoring Board (DSMB) analyzed safety results from the preliminary four-week treatment with NOX-A12 plus radiotherapy and bevacizumab in the first subject in the expansion arm of the trial.
The DSMB concluded that the treatment is safe and suitable to progress recruitment to enroll five more subjects into this arm as per the protocol of the trial.
Furthermore, the company noted that the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) granted approval for the third expansion arm of the trial.
Subjects in this arm will be given NOX-A12 plus pembrolizumab, an inhibitor of programmed cell death protein 1 (PD-1) immune checkpoint, and radiotherapy.
In the GLORIA Phase I/II trial, the safety and efficacy of NOX-A12 plus radiotherapy will be analyzed in recently detected glioblastoma in subjects with unmethylated MGMT promoter.
Three expansion arms of the trial will each enroll six subjects to assess NOX-A12 advantage in various treatment settings.
Arm A will study NOX-A12 plus radiotherapy in individuals with complete tumor resection.
Arm B will evaluate the treatment, along with radiotherapy and bevacizumab, in incomplete tumor resection patients while Arm C will assess NOX-A12 plus radiotherapy and pembrolizumab in subjects with incomplete tumor resection.
Noxxon Pharma CEO Aram Mangasarian said: “The three arms in the expansion of our Phase I/II 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 in brain tumor tissue.”
In March 2021, Noxxon obtained a positive recommendation from the DSMB to progress recruitment in a brain cancer study of NOX-A12 plus radiotherapy.