NOXXON Pharma N.V. announced an updated strategy to focus its capabilities on NOX-A12 in brain cancer (glioblastoma) and in particular on the triple combination of NOX-A12, radiotherapy and bevacizumab. This decision follows positive data generated in the GLORIA Phase 1/2 study, consisting of a dose-escalation part with NOX-A12 plus radiotherapy and a triple combination part with NOX-A12, radiotherapy and bevacizumab of which initial results are announced. The data from the GLORIA dose-escalation part of the trial (reported at ASCO 2022) showed that 90% of patients treated with NOX-A12 and radiotherapy achieved tumor size reductions; 40% of all were even reaching radiographic partial response (defined as =50% reduction in tumor size).

The interim results from the triple combination part now further validate the safety and suggest even deeper and more sustained responses. All five patients that completed radiotherapy and are under NOX-A12/bevacizumab therapy achieved radiographic partial responses in the initial MRI scan. In two patients that have already been assessed at 4 and 6 months, respectively, these radiographic partial responses were maintained.

Reductions in tumor size at latest time-points as assessed by an independent central reader range from -54.7% to -94.7%. NOXXON targets disclosure of detailed data, including longer follow-up at a scientific conference later this year. With this strategy, NOXXON is aiming to maximize the opportunity to successfully develop NOX-A12 in glioblastoma, while also increasing potential returns to shareholders by considering fully self-financed clinical development, as well as global or partial geographic partnerships.

Following this decision, all significant R&D activities on projects unrelated to glioblastoma will be placed on hold and alternative strategies will be defined over the coming months. Such alternatives include, without being limited to, Investigator Initiated Trials (IITs), local and global out-licensing, partnering for specific indications, and divestments. The planned Phase 2 OPTIMUS trial of NOX-A12 in pancreatic cancer has been fully approved in France and Spain and NOXXON aims to finalize discussions with the US Food and Drug Administration (FDA) on the design such that the trial could be initiated rapidly when appropriate financing is available.

The GLORIA Phase 1/2 expansion arm in triple combination of NOX-A12, radiotherapy and bevacizumab in glioblastoma has completed recruitment of 6 patients and anticipates top line data on the six patients to be available in Fourth Quarter 2022. The recruitment of patients into the arm with pembrolizumab is ongoing. Data from the dose escalation and expansion arms will form the basis for discussions with the FDA and European regulators to discuss pathways to marketing authorization.