Nuvectis Pharma, Inc. announced preliminary data from the ongoing Phase 1b clinical trial of NXP800 in patients with platinum resistant ARID1a-mutated ovarian cancer, a deadly disease of unmet medical need. The NXP800 development program in this disease was granted Fast Track Designation by the U.S. Food and Drug Administration ("FDA"). The Phase 1b clinical trial is being conducted in top clinical centers in the United States and the United Kingdom.

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. About the Phase 1b Study The Phase 1b study is a multicenter, single arm, open-label clinical trial of N XP800 in patients with platinum-resistant, ARID1a-mutate ovarian cancer. 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.

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 by the FDA. NXP800 completed a Phase 1a dose-escalation study in the first half of 2023. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-Mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholongiocarcinoma.

The U.S. Food and drug Administration granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1 a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholANGiocarcinoma.