NOXXON Pharma, a renowned biopharmaceutical firm based in Germany that is focused at enhancing cancer treatment by aiming at the TME (tumor microenvironment), reportedly announced the enrollment as well as treatment of the first patient in a phase 1/2 clinical trial that assesses NOX-A12 along with radiotherapy for newly diagnosed brain cancer.

The trial investigates an integrated treatment of increasing doses of the inhibitor of CXCL12, NOX-A12, as well as external-beam radiotherapy. In this trial, NOX-A12 administration is planned for up to six months.

The clinical study is being conducted in three hospitals located in Germany. Up to three NOX-A12 escalating doses would be administered along with standard radiotherapy, just as a first line therapy to newly diagnosed patients.

The projected mode of action of the inhibitor NOX-A12 is inhibition of unwanted influx of the “repair cells” derived from the bone marrow to the tumor after radiotherapy-induced breakdown of the vasculature present in the tumor. These “repair cells” further operate by replacing the blood vessels of the tumor that were destroyed due to the irradiation, which eventually results in recurrence of the disease.

The study is built to deliver first efficacy and safety data in order to support the definition of RP2D (Recommended Phase 2 Dose) for this novel treatment approach. Additionally, the noninvasive assessment of the variations in tumor vascularization is hoped to confirm the projected mechanism of action for the NOX-A12 and radiotherapy combination. 

Chief Medical Officer of NOXXON, Dr. Jarl Ulf Jungnelius stated that on the basis of favorable preclinical data in mouse and rat models, the company is thrilled to assess NOX-A12 in the next indication. It is a promising and unique approach with the capability to treat patients with brain cancer effectively, patients who presently don’t have any optimal therapies.

Jungnelius added that the overall clinical community demand for the testing of this integration has been immensely strong and the company is pleased that the patient dosing has been initiated. The company expects data from its initial cohort of patients to be ready in mid-2020.

NOXXON had recently showcased its data from its phase 1/2 Keytruda® / NOX-A12 combination clinical trial for metastatic pancreatic as well as colorectal cancer at the European Society for Medical Oncology, held in Barcelona, Spain.

Source credit: https://www.noxxon.com/downloads/pressrel/2019-10-16_Initiation_of_Dosing_GBM_EN.pdf