BERLIN--(BUSINESS WIRE)--Regulatory News:
NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today that the Data Safety Monitoring Board (DSMB) analyzed safety data from the initial four weeks of treatment of the first patient enrolled in the third and final dose cohort of the NOX-A12 plus radiotherapy brain cancer study. The DSMB concluded that it is safe and appropriate to continue patient recruitment according to the study protocol. The DSMB’s decision marks an important milestone in this trial as it enables the advancement and analysis of the final dose regimen, placing NOXXON on the path toward valuable data readouts anticipated later this year.
The Phase 1/2 clinical study is testing three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy, in newly diagnosed brain cancer patients. Based on the DSMB’s confirmation, participating clinical centers have now initiated final patient recruitment for the last and highest dose group. After all patients in the third cohort have received four weeks of treatment with NOX-A12 and radiotherapy, the DSMB will reconvene for a final meeting to assess safety and tolerability. The outcome of this meeting will inform the recommended dose for the next randomized, controlled brain cancer trial which will lead to the registration of NOX-A12.
“We are pleased by the safety data confirmation of the DSMB, as it will allow our study to progress and the last patients to receive treatment at the highest planned dose of NOX-A12. This achievement brings us one step closer to a topline data readout for this cohort sometime around the end of Q3 2021,” commented Aram Mangasarian, CEO of NOXXON. “As the study advances, we will be analyzing data which will be used to define the recommended dose and guide preparations for a potentially registrational Phase 2 study. The recent capital raise plus available financing vehicles secure NOXXON’s financial runway well into 2022, thereby allowing us to address operational matters crucial for the future of the company.”
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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