On October 16, 2019 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the enrollment and first treatment of a patient with newly diagnosed brain cancer in a phase 1/2 clinical trial (Press release, NOXXON, OCT 16, 2019, View Source [SID1234542276]). The study investigates a combined therapy of increasing doses of the CXCL12 inhibitor, NOX-A12, and external-beam radiotherapy. Within this study, NOX-A12 administration in planned for up to six months. The anticipated mode of action of NOX-A12 is the inhibition of the unwanted influx of bone marrow-derived "repair cells" to the tumor following radiotherapy-induced breakdown of the vasculature in the tumor. These "repair cells" act by replacing the tumor’s blood vessels that were destroyed by the irradiation, which ultimately results in disease recurrence.
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The study is designed to deliver safety and first efficacy data to support the definition of a Recommended Phase 2 Dose (RP2D) for this new treatment approach. In addition, the noninvasive assessment of the changes in tumor vascularization is expected to confirm the predicted mechanism of action for the combination of NOX-A12 and radiotherapy.
"The trial represents a new option for very difficult-to-treat patients. The candidate drug should block the influx of two distinct types of cells that the damaged brain tumor tries to recruit to help repair itself and survive. A plethora of pre-clinical studies as well as a recent clinical trial at Stanford yielded promising results with interventions targeting the CXCL12 pathway. We learnt some lessons from these data, and we are very optimistic that blocking both cell types for a longer duration will be even more effective," commented Dr. Frank Giordano, Interim Director of the Department of Radiation Oncology at the University Medical Center Mannheim.
"Based on promising preclinical data in rat and mouse models, we are excited to evaluate NOX-A12 in this indication. It is a unique and promising approach with the potential to effectively treat brain cancer patients for whom there are currently no optimal therapies. The demand from the clinical community to test this combination has been very strong and we are pleased that the dosing of patients has been initiated. We expect data from the first cohort of patients to be available in mid-2020," added Dr. Jarl Ulf Jungnelius, Chief Medical Officer of NOXXON.
The trial is being conducted at three hospitals in Germany. Up to three escalating doses of NOX-A12 will be administered in combination with standard radiotherapy as a first line treatment to newly diagnosed patients with brain tumors who would not benefit from the current standard of care of chemotherapy and whose tumors cannot be fully resected by surgery. The main objective of the study is to assess the safety and tolerability of this combination. Secondary endpoints include activity of the therapy, assessed through the monitoring of tumor vascularization by MRI scans, progression-free survival, overall survival and rates of response.