On October 19, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALONOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the expansion plans of its ongoing Phase 1/2 study of NOX‑A12 in combination with radiotherapy in patients with brain cancer (glioblastoma, GBM) (Press release, NOXXON, OCT 19, 2021, View Source [SID1234591526]).
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The company plans to expand the ongoing GLORIA study to include additional patients in three new arms in the first-line chemotherapy resistant population (unmethylated MGMT promoter) at the highest 600 mg/week dose of NOX-A12 combined with radiotherapy:
– 6 patients with fully resected tumor will receive radiotherapy and NOX-A12;
– 6 patients with partially resected or unresected tumor will receive bevacizumab in combination with radiotherapy and NOX-A12;
– 6 patients with partially resected or unresected tumor will receive a PD-1 immune checkpoint inhibitor in combination with radiotherapy and NOX-A12.
These expansion arms come in addition to the ongoing Phase 1/2 trial evaluating three ascending doses of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. Positive data from the first two cohorts at 200 and 400 mg/week have already been reported and data from the third cohort at 600 mg/week for which patient recruitment has been completed will be reported in Q1 2022. A protocol amendment to expand the study with the first two arms above has been approved by the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte), and another amendment for the third arm is being prepared. Once enrolled in the study, patients will be treated for 6 months.
"The expansion of our Phase 1/2 study of NOX-A12 in brain tumor patients will allow us to explore three further treatment configurations, all of which are supported by the clinical data emerging from the GLORIA trial. We will extend our safety data to the full surgical resection population, as we also plan to include this population of patients in our future pivotal glioblastoma study.
In addition, the extensions will assess the safety and potential synergistic benefit of NOX-A12 with anti-PD-1 and anti-VEGF combinations. Our interest in the anti-PD-1 combination is driven by the observation that NOX-A12 appears to drive infiltration of activated cytotoxic immune cells into the tumor tissue, and thus the combination with anti-PD-1 is expected to unlock a significantly stronger tumor response. We will also test a combination with anti-VEGF therapy which is commonly used in this patient population. We look forward to evaluating all these combinations," commented Aram Mangasarian, CEO of NOXXON.
NOX-A12 targets CXCL12, a crucial signal molecule that is used by malignant cells to form the tumor microenvironment to their favor, and is designed to (i) prevent tumor recurrence after radiotherapy by blocking the influx of tumor repair cells from the bone marrow and (ii) modify the tumor microenvironment in order to enable the action of anti-cancer immune cells, such as killer T-cells.