Nuvectis Pharma Announces FDA Clearance of IND for NXP800
Nuvectis Pharma, Inc., 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.
“The FDA approval of the IND for NXP800 marks an important milestone towards our mission of developing novel treatments for unmet medical needs in oncology” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. “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.” Mr. Bentsur added, “We look forward to building on the substantial interest that NXP800 has garnered in the medical community and to working with leading clinical centers in the U.S. and the U.K. on this important project.”
Mr. Bentsur concluded, "With the progress that we continue to make with NXP800 and NXP900, our novel, oral and highly-specific SRC/YES1 kinase inhibitor, which is expected to enter the clinic in early 2023, we believe that we are emerging as an exciting precision medicine company."
About NXP800
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.
NXP800 is currently in a Phase 1 clinical trial that is comprised of two parts: dose-escalation Phase 1a, to be followed by an expansion Phase 1b. In the Phase 1a, the safety and tolerability of NXP800 is being evaluated in patients with advanced solid tumors to identify a dose and dosing schedule for the Phase 1b. In the Phase 1b study, the safety and preliminary anti-tumor activity of NXP800 will be evaluated, initially in Arid1a-mutated ovarian clear cell carcinoma and ovarian endometrioid carcinoma, Nuvectis expects to include additional arms in the Phase 1b study based on the results of the ongoing in-vivo studies in other tumor types. The Company plans to initiate the Phase 1b in early 2023.
NXP800 has the potential to become a first-in-class inhibitor of the HSF1 pathway.
About Nuvectis
Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company's pipeline includes NXP800, a clinical-stage HSF1-pathway inhibitor, and NXP900, a SRC/YES1 kinase inhibitor in IND-enabling studies.
Jun 21, 2022
