NOXXON Provides Update on Evaluation of NOX-A12 in Non-Oncology Indication by a Leading International Pharma Company

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 evaluation of NOX-A12 by a leading international pharmaceutical company in a non-oncology indication announced on June 24, 2019 has been completed. The pharmaceutical company has decided not to pursue further work with NOX-A12 in this field and to terminate the collaboration agreement. The indication will remain undisclosed.

“While this decision comes as a disappointment to us and our shareholders, the significant investment in time and resources of the pharmaceutical partner over the last two years to evaluate NOX-A12 in a non-oncology indication indicates the unique potential of NOX-A12’s direct chemokine-targeting action versus competing single receptor agents that do not fully block CXCL12-receptor interactions. While the biological hypothesis tested by the pharmaceutical partner did not work in the evaluated indication, we are pleased that the pharma research and development team worked so diligently on testing this additional therapeutic potential of NOX-A12. We remain committed to the development of NOX-A12 in oncology indications and look forward to updating the market on clinical progress we make in brain and pancreatic cancers,” said Aram Mangasarian, CEO of NOXXON.

NOX-A12 is currently under clinical development in two indications:

1. Glioblastoma (GBM) – a Phase 1/2 study of NOX-A12 + radiotherapy (GLORIA) in patients newly diagnosed with aggressive brain cancer is ongoing. All patients have been recruited in all three dose cohorts (200, 400 or 600 mg NOX-A12 per week), and will have completed 6 months of therapy in Q1 2022. Based on the encouraging data obtained from the two initial dose cohorts, expansion arms of the study have been initiated to assess potential synergistic benefit of NOX-A12 with additional treatment combinations. As a next step, a pivotal trial is planned to start in 2022.
2. Pancreatic cancer – following the promising results from the OPERA trial, a Phase 2 study (OPTIMUS) comparing two NOX-A12 combinations with anti-PD-1 antibody and two different standard of care chemotherapy regimens in second-line patients is expected to start in 2022. For this trial, NOXXON and MSD (Merck & Co., Inc., Kenilworth, N.J. USA) have entered into their second collaboration.

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.

For more information, please contact:

NOXXON Pharma N.V.
Aram Mangasarian, Ph.D.
Chief Executive Officer
Tel. +49 (0) 30 726247 0
amangasarian@noxxon.com

Investor and Media Relations:

LifeSci Advisors
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31
gvanrenterghem@lifesciadvisors.com

NewCap
Arthur Rouillé
Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr