Nuvectis: FDA Clears IND for cancer candidate

 Nuvectis Pharma, Inc. (“Nuvectis”, “Company”), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that the U.S. Food and Drug Administration (“FDA”) cleared the Company's Investigational New Drug Application (“IND”) for NXP800, which includes the Phase 1 clinical trial protocol. The NXP800 Phase 1 clinical trial is comprised of two parts, a dose escalation study (“Phase 1a”) to be followed by an expansion study (“Phase 1b”). The Phase 1a is currently ongoing in the United Kingdom (“U.K.”) and, with the IND in effect, U.S. clinical sites will now be included. The Company expects to initiate the Phase 1b study in early 2023.

Nuvectis licensed exclusive world-wide rights to NXP800, a novel, oral Heat Shock Factor 1 (“HSF1”) pathway inhibitor, which was discovered at the Institute of Cancer Research in London, England. The HSF1 pathway is implicated in cancer cell growth, metastasis, and survival across several types of cancer. In preclinical studies, NXP800 demonstrated potent anti-proliferative activity against a variety of cancer cell lines, and inhibited tumor growth in ARID1A-mutated ovarian clear cell carcinoma and ovarian endometrioid carcinoma human xenograft models. Nuvectis is conducting further in vivo studies to evaluate the potential use of NXP800 in additional tumor types, including gastric, liver and esophageal cancers, with and without mutations in ARID1a and other biomarkers.

https://finance.yahoo.com/news/nuvectis-pharma-announces-fda-clearance-121500155.html