BERLIN--(BUSINESS WIRE)--Regulatory News:
NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (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) positively evaluated safety data from the initial four weeks of treatment of the first patient enrolled in the GLORIA clinical trial expansion arm with NOX-A12 combined with radiotherapy and bevacizumab. The DSMB concluded that it is safe and appropriate to continue recruitment of five additional remaining patients into this arm according to the study protocol. NOXXON also announced that the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) approved the third expansion arm of the GLORIA clinical trial in which patients will receive the PD-1 immune checkpoint inhibitor pembrolizumab in combination with NOX-A12 and radiotherapy.
Aram Mangasarian, CEO of NOXXON, commented: "The three arms in the expansion of our Phase 1/2 study of NOX-A12 are supported by the clinical data from the GLORIA trial and are designed to explore the potential for improved benefits for patients with brain tumors. The combination with the anti-PD-1 inhibitor pembrolizumab is of particular interest as we expect this combination therapy to unlock a stronger and more durable immune response against the tumor. This is based on our previous observation that NOX-A12 drives infiltration of activated cytotoxic immune cells into brain tumor tissue. We plan to use clinical data from the expansion arms to support our future pivotal glioblastoma study."
The GLORIA Phase 1/2 clinical trial evaluates the safety and efficacy of NOX-A12 combined with radiotherapy in newly diagnosed brain cancer (glioblastoma) patients with unmethylated MGMT promoter. Three expansion arms, each intending to enrol six patients, will evaluate the benefit of NOX-A12 in other therapeutic settings:
- Arm A: NOX-A12 with radiotherapy in patients with complete tumor resection
- Arm B: NOX-A12 with radiotherapy and bevacizumab in patients with incomplete tumor resection
- Arm C: NOX-A12 with radiotherapy and pembrolizumab in patients with incomplete tumor resection.
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 in July 2021 the company announced its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic 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. GLORIA, a trial of NOX-A12 in combination with radiotherapy in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy has delivered interim data from the first two cohorts showing consistent tumor reductions and objective tumor responses. 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. Further information can be found at: www.noxxon.com.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.
About the GLORIA Study
GLORIA (NCT04121455) is NOXXON’s dose-escalation, phase 1/2 study of NOX-A12 in combination with irradiation in first-line glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy).
About the OPTIMUS Study
OPTIMUS (NCT04901741) is NOXXON’s open-label two-arm phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.
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