Full Press Release Details
Nuvectis Pharma Announces FDA Clearance of NXP900
2023, Fort Lee, NJ - 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.
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.
Nuvectis Pharma, Inc. is 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. The Company is currently developing two drug candidates, NXP800 and NXP900. NXP800 is a clinical
stage, oral small molecule currently in a Phase 1b study. NXP800 was granted Fast Track Designation by the FDA for the treatment of
platinum-resistant, ARID1a-mutated, ovarian carcinoma. NXP900 is a novel
inhibitor of SFKs with low nanomolar potency against YES1 and SRC. The IND for NXP900 has been cleared by the FDA and the Phase 1a study
is expected to commence in the coming months.
For more information, please visit www.nuvectis.com.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements,
other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements
contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate,"
"could," "estimate," "expect," "intend," "seek," "may," "might,"
"plan," "potential," "predict," "project," "target," "aim," "should,"
"will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements
contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections
about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business
strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties,
risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements regarding the
preclinical data generated to date for NXP800 and NXP900, the Phase 1a data generated for NXP800, including the safety, tolerability
and other observations from the NXP800 Phase 1a study, and timing, and safety, tolerability and efficacy data from the NXP800 Phase 1b
study, and timing of the commencement of the Phase 1a study for NXP900, and NXP800 and NXP900's clinical potential as single agents or
in combination with other approved drugs. Further, certain forward-looking statements are based on assumptions as to future events that
may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully
in the section titled "Risk Factors" in our 2022 Form 10-K filed with the Securities and Exchange Commission ("SEC").
However, these risks are not exhaustive and new risks and uncertainties emerge from time to time and it is not possible for us to predict
all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings
with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly
disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein
to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based,
except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995.
Nuvectis Pharma Contact:
Chairman, Chief Executive Officer and President
Media Relations Contact:
Christopher M. Calabrese