NOXXON Enrolls Last Brain Cancer Patient in Dose Escalation Portion of GLORIA Study and Confirms Phase 1/2 Read-Out in Q1 2022

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), announces today that the tenth and last patient with newly diagnosed brain cancer was enrolled into the third cohort of the Phase 1/2 clinical study and has been receiving the high dose (600 mg/week) of NOX-A12 for one week now. This patient will receive treatment and be monitored for six months leading to Phase 1/2 data expected in Q1 2022, as previously guided. An expansion phase will be the next step in this trial to obtain clinical data in additional patients with brain cancer.

The GLORIA study investigates a combined therapy of increasing doses of the CXCL12 inhibitor, NOX-A12, and external-beam radiotherapy in newly diagnosed brain cancer patients. Three dose regimens of NOX-A12 (200, 400 and 600 mg/week) are being tested and administrated for up to six months.

Dr. Jarl Ulf Jungnelius, Senior Medical Advisor at NOXXON, commented: “We are pleased to announce the enrollment of the dose escalation portion of this study is complete. Based on the positive data from the previous two dose cohorts, we are looking forward to seeing the safety and first efficacy signals of NOX-A12 in the last cohort. The combination therapy is a unique and promising approach with realistic potential to treat brain cancer patients for whom there are currently no optimal therapies. We expect data from the third and last dose escalation cohort of patients to be available in Q1 2022.”

Positive data from six patients in the first two cohorts was reported (three patients receiving 200 mg/week and three patients receiving 400 mg/week) with over 83% of these patients showing reductions in tumor size during or after NOX-A12 treatment with maximal reductions from baseline ranging from 2% to 62% for patients treated at 200 mg/week (first cohort), and 28% and 71% for two patients treated at 400 mg/week (second cohort). These patients tolerated combined radiotherapy and NOX-A12 therapy well without any signs of dose-limiting toxicities.

About 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 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

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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.

Disclaimer

Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for updating such information, which only represents the state of affairs on the day of publication.

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