»Noxxon Announces Planned Expansion of Phase 1/2 NOX-A12 Brain Cancer Trial MyPharma Editions

Posted on Tuesday, October 19, 2021

Noxxon Pharma, a biotechnology company specializing in the development of improved cancer treatments targeting the tumor microenvironment (MET), announced plans to expand its ongoing phase 1/2 clinical study of NOX-A12 in combination with radiotherapy in patients with glioblastoma (brain cancer).

The company plans to expand the ongoing GLORIA study to include additional patients in three expansion pathways for the treatment of the first-line chemotherapy-resistant (unmethylated MGMT promoter) population receiving the highest dose NOX-A12 (600 mg / week), in combination with radiotherapy:

. 6 patients whose tumor has been completely resected will be treated by the combination of NOX-A12 with radiotherapy;
. 6 patients with a partially resected or unresected tumor will be treated by the combination of NOX-A12 with radiotherapy as well as bevacizumbab;
. 6 patients with a partially resected or unresected tumor will be treated with the combination of NOX-A12 with radiotherapy as well as a PD-1 immune checkpoint inhibitor.

These three expansion pathways are in addition to the ongoing Phase 1/2 trial evaluating three dosing regimens of NOX-A12 (200, 400 and 600 mg / week), combined with external beam radiation therapy in patients with recently diagnosed brain cancer. Patients from the first two cohorts receiving 200 and 400 mg / week reported positive data. The recruitment of the patients of the third cohort receiving 600 mg / week has been completed and the results are expected in the first quarter of 2022. An amendment to the clinical protocol to extend the study to the first two routes mentioned above has been approved. by the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte). Another amendment for the third way is in preparation. Once enrolled for the study, patients will receive treatment for 6 months.

“In parallel, the extension of our phase 1/2 study on NOX-A12 in patients with brain tumors will allow us to explore three other treatment configurations, all supported by clinical data from the GLORIA study. We are going to expand our database to cover the entire population undergoing complete surgical resection. We also plan to include this patient population in our next major glioblastoma study.

These extensions will also allow evaluation of the safety and potential synergistic benefit of NOX-A12 combined with anti-PD-1 and anti-VEGF. Our interest in a combination with an anti-PD-1 is motivated by the observation that NOX-A12 appears to promote the infiltration of activated cytotoxic immune cells into tumor tissue. The combination with an anti-PD-1 could therefore allow a much stronger tumor response.

We will also test a combination with an anti-VEGF treatment, common for this type of patient. We look forward to evaluating all of these combinations, ”commented Aram Mangasarian, CEO of NOXXON.

NOX-A12 targets CXCL12, a crucial signaling molecule used by malignant cells to form a favorable tumor microenvironment, and is designed to (i) prevent tumor recurrence after radiation therapy by blocking the influx of tumor repair cells from the bone marrow and (ii) modify the tumor microenvironment to enable the action of anti-cancer immune cells, such as killer T cells.

Source and visual: NOXXON

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