On September 22, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that the tenth and last patient with newly diagnosed brain cancer was enrolled into the third cohort of the Phase 1/2 clinical study and has been receiving the high dose (600 mg/week) of NOX-A12 for one week now (Press release, NOXXON, SEP 22, 2021, View Source [SID1234590135]). This patient will receive treatment and be monitored for six months leading to Phase 1/2 data expected in Q1 2022, as previously guided. An expansion phase will be the next step in this trial to obtain clinical data in additional patients with brain cancer.
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The GLORIA study investigates a combined therapy of increasing doses of the CXCL12 inhibitor, NOX-A12, and external-beam radiotherapy in newly diagnosed brain cancer patients. Three dose regimens of NOX-A12 (200, 400 and 600 mg/week) are being tested and administrated for up to six months.
Dr. Jarl Ulf Jungnelius, Senior Medical Advisor at NOXXON, commented: "We are pleased to announce the enrollment of the dose escalation portion of this study is complete. Based on the positive data from the previous two dose cohorts, we are looking forward to seeing the safety and first efficacy signals of NOX-A12 in the last cohort. The combination therapy is a unique and promising approach with realistic potential to treat brain cancer patients for whom there are currently no optimal therapies. We expect data from the third and last dose escalation cohort of patients to be available in Q1 2022."
Positive data from six patients in the first two cohorts was reported (three patients receiving 200 mg/week and three patients receiving 400 mg/week) with over 83% of these patients showing reductions in tumor size during or after NOX-A12 treatment with maximal reductions from baseline ranging from 2% to 62% for patients treated at 200 mg/week (first cohort), and 28% and 71% for two patients treated at 400 mg/week (second cohort). These patients tolerated combined radiotherapy and NOX-A12 therapy well without any signs of dose-limiting toxicities.