Nuvectis Pharma Announces Encouraging Preliminary Data from the NXP800 Phase 1b Clinical Trial in Platinum-Resistant ARID1a-Mutated Ovarian Cancer - Seite 2

Preliminary Clinical Data Summary

Encouraging preliminary efficacy data was observed and includes data from the first four patients enrolled in the study, two treated with 75 mg/day and two treated with 50 mg/day. All patients failed at least two prior lines of systemic chemotherapy, including at least one prior platinum-based chemotherapy regimen. Three of the patients also failed prior treatment with bevacizumab (Avastin). Efficacy was evaluated in three of the four patients.

One patient treated with 75 mg/day achieved a PR, unconfirmed, that also included a CR of her non-target lymph node disease. Both patients treated with 50 mg/day achieved SD and the fourth patient was not evaluated for efficacy.

Three of these four patients experienced an adverse event of thrombocytopenia that was Grade 4 in intensity, these events were transient in nature with no concurrent bleeding events reported. Following these events, as mentioned above, a management procedure for the monitoring of platelets and dose adjustments, as necessary, has been implemented with the goal of minimizing dosing interruptions and increasing patient retention. No other ≥ Grade 3 hematological toxicities were reported. In addition, gastrointestinal adverse events were reported in all four patients, all Grade 1-2.

About the Phase 1b Study

The Phase 1b study is a multicenter, single arm, open-label clinical trial of NXP800 in patients with platinum-resistant, ARID1a-mutated ovarian cancer. The study is examining the safety and preliminary efficacy of NXP800 in this target patient population.

The study is being conducted in the US and UK in collaboration with the European Network of Gynecological Oncological Trial Groups and the GOG Foundation, Inc., recognized as the world's leading gynecology oncology clinical trials consortia.

About NXP800

NXP800 is an oral, small molecule, potentially first-in-class GCN2 kinase activator. NXP800 is also being evaluated in an investigator-initiated study conducted in collaboration with the Mayo Clinic for the treatment of cholangiocarcinoma, an indication for which the FDA granted NXP800 Orphan Drug Designation. The NXP800 development program in platinum-resistant, ARID1a-mutated ovarian cancer was granted Fast Track Designation by the FDA. NXP800 completed a Phase 1a dose-escalation study in the first half of 2023.