NEW YORK – Nuvectis Pharma said on Tuesday the US Food and Drug Administration cleared its investigational new drug application for its HSF1 inhibitor NXP800 to begin a Phase I trial in ARID1A-mutated ovarian cancer and ovarian endometrioid cancer.
The Phase Ia portion of the study will enroll patients with advanced solid tumors to determine the appropriate dose and dosing schedule. In the Phase Ib portion, researchers will enroll patients with ARID1A-mutated ovarian cancer and ovarian endometrioid cancer. The company expects to study additional indications and add new arms to the multi-cohort trial based on results from ongoing preclinical studies.
Nuvectis is currently enrolling patients in the Phase Ia portion of the trial at sites in the US and UK. The Phase Ib part of the study is expected to begin in early 2023.
"We continue to effectively execute our clinical development strategy for NXP800, with the hope of it becoming the first drug approved for ARID1A-mutated ovarian clear cell carcinoma and endometrioid ovarian carcinoma, and potentially for additional cancers of unmet medical need," Nuvectis CEO Ron Bentsur said in a statement.
Nuvectis, based in Fort Lee, New Jersey, licensed worldwide rights to NXP800 from CRT Pioneer Fund, a UK-based specialty oncology investment fund, in August 2021. The drug was discovered at the Institute of Cancer Research in London, England.
The company is also developing an SRC/YES1 inhibitor, NXP900, which it expects to take into the clinic next year. Nuvectis licensed NXP900 last year from the University of Edinburgh in Scotland.