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

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.

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