NOXXON Announces Data Safety Monitoring Board Validates NOX-A12 Highest Dose in Phase 1/2 Brain Cancer Trial
BERLIN--(BUSINESS WIRE)--Regulatory News:
NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today that an independent Data Safety Monitoring Board (DSMB) has confirmed that the highest dose of NOX-A12 in combination with radiotherapy in the ongoing Phase 1/2 study in patients with brain cancer is safe and that the trial should continue as planned.
The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. The DSMB recommendation to proceed followed the analysis of safety data stipulated in the study protocol after all three patients in the third – and last – cohort completed at least four weeks of treatment at the highest dose.
“We are pleased that the DSMB analysis has concluded that the highest dose of NOX-A12 in this Phase 1/2 study in brain cancer patients is safe. We look forward to continuing to investigate this exciting potential treatment and continue to expect top-line data for Cohort 2 end-May and Cohort 3 in November 2021,” commented Aram Mangasarian, CEO of NOXXON.
NOXXON’s oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking the tumor protection barrier and blocking tumor repair. By neutralizing chemokines in the TME, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. NOXXON’s lead program NOX-A12 has delivered final top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients published at the ESMO conference in September 2020 and based on the trial results, including overall survival and safety profile, further studies are being planned in pancreatic cancer. NOXXON is also studying NOX-A12 in brain cancer in combination with radiotherapy which has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. A trial of NOX-A12 in combination with radiotherapy in newly diagnosed brain cancer patients who will not benefit from standard chemotherapy has delivered preliminary data from the first cohort showing consistent tumor reductions. The company’s second clinical-stage asset NOX-E36 is a Phase 2 TME asset targeting the innate immune system. NOXXON plans to test NOX‑E36 in patients with solid tumors both as a monotherapy and in combination. Further information can be found at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp
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NOXXON Pharma N.V.
Aram Mangasarian, Ph.D.
Chief Executive Officer
Tel. +49 (0) 30 726247 0
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31
Tel. +33 (0) 1 44 71 00 15