As part of the NXP800 Phase 1b study, 17 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer were treated with NXP800 at the target dose of 75 mg/day, administered intermittently or daily, with data available for 13 patients. Overall, treatment resulted in 2 patients achieving partial response (unconfirmed) and 3 achieving stable disease. Thrombocytopenia, a key toxicity identified early in the study, was successfully managed following the switch to intermittent dosing. The company will not pursue further development of NXP800 in ovarian cancer but, in the coming months, will evaluate the feasibility of development opportunities for NXP800 in other cancer types, such as endometrial and prostate cancers, in which the patients' performance status and other characteristics may allow treatment with NXP800 to be more impactful.
With the recent successful completion of the NXP900 DDI study, which supports the potential combination of NXP900 with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors in non-small cell lung cancer (NSCLC), and now the successful completion of the Phase 1a dose-escalation study, the Company is poised for the start of the Phase 1b study of NXP900, expected in the coming weeks. The Phase 1a dose escalation study evaluated the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of NXP900 in patients with advanced solid tumors (all comers). In this study, a dose range of 20 to 300 mg/day was evaluated and the dose limiting toxicity dose level was not reached. As presented by the study investigators at the 2025 American Association for Cancer Research (AACR) conference, the most common treatment emergent adverse events were mainly gastrointestinal-related and mild to moderate in intensity; systemic exposure to NXP900 increased with increased doses and a robust pharmacodynamic response of approximately 90% inhibition of SRC kinase phosphorylation was elicited at doses of 150 mg/day and higher, suggesting a potentially wide therapeutic window. The final data from the study is expected to be presented at a future medical/scientific conference.
Available data from 13 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer treated with 75 mg/day in the NXP800 Phase 1b study includes 2 partial responses and 3 stable diseases; thrombocytopenia successfully managed with intermittent dosing schedule; observed clinical activity warrants exploration of potential development opportunities in other cancer types
NXP900 successfully completed a clinical drug-drug interaction (DDI) study in healthy volunteers and the Phase 1a dose escalation study; initiation of the NXP900 Phase 1b program to evaluate the safety and efficacy of NXP900 as a single agent and in combination with other anti-cancer agents expected in the coming weeks

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