Pharma Focus Asia

Nuvectis Pharma Announces FDA Clearance of NXP900 IND

Tuesday, May 16, 2023

Nuvectis Pharma 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.

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.

The IND clearance by the FDA is a significant milestone for the NXP900 development programme. NXP900 presents a unique opportunity due to its differentiated mechanism of action and pharmacologic attributes.

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