Tuesday, May 16, 2023
Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage 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 NXP900, which includes the Phase 1 clinical trial protocol.
“The IND clearance by the FDA is a significant milestone for the NXP900 development program and for our overall corporate strategy, further demonstrating our ability to execute our business plan,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, “Nuvectis now has two precision oncology, clinical-stage drug candidates, each with several potential opportunities in cancers that represent serious conditions of unmet medical need. We believe that NXP900 presents a unique opportunity due to its differentiated mechanism of action and pharmacologic attributes, and we are excited to start the clinical program to unlock its therapeutic potential.”
Nuvectis licensed exclusive world-wide rights to NXP900, a novel inhibitor of the SRC family of kinases (“SFKs”) with low nanomolar potency against YES1 and SRC, from the University of Edinburgh in Scotland. Over activation of SFKs occurs frequently in tumor tissues and they are central mediators in multiple oncogenic signaling pathways. YES1, a key member of the SFKs, enhances the phosphorylation, nuclear localization and oncogenic activity of YAP1, a key Hippo pathway effector. In preclinical studies, NXP900 demonstrated robust single agent antitumor activity in several in vivo xenograft models, including in squamous cell cancers such as cervical, head and neck and esophageal carcinomas in which Hippo pathway mutations and copy number abnormalities are prevalent. In addition, NXP900 in combination with osimertinib (the active ingredient in TAGRISSO®) in vitro and with enzalutamide (the active ingredient in Xtandi®) in vivo demonstrated the potential ability to reverse acquired resistance to these drugs in non-small cell lung cancer and metastatic castration-resistant prostate cancer, respectively.