Nuvectis Pharma announces the granting of Orphan Drug status

FORT LEE, NJ, Aug. 29, 2024 (GLOBE NEWSWIRE) — Nuvectis Pharma, Inc. (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative precision medicines to treat serious diseases with unmet medical needs in oncology, today announced that NXP800 has received Orphan Drug Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of AT-rich interactive domain-containing protein 1a (ARID1a)-deficient ovarian cancer, fallopian tube cancer and primary peritoneal cancer.

Ron Bentsur, Chairman and CEO of Nuvectis, commented: “We are very pleased with this FDA approval for NXP800. The prevalence of ovarian cancer, which consists of ovarian, fallopian tube and primary peritoneal cancer, exceeds the 200,000 patient threshold below which drugs are eligible for orphan drug treatment in the United States, and in ovarian cancer, it is unusual to receive this approval to treat a subset of the disease. Therefore, we believe that this FDA approval of NXP800 to treat a subset of ovarian cancer, specifically patients with ARID1a deficiency, provides further validation of the mechanism of action of NXP800 and the target patient population in our ongoing Phase 1b clinical trial in patients with platinum-resistant, ARID1a-mutated ovarian cancer. We expect to provide a data update from this trial next fall.”

About the status of an orphan drug

Orphan drug designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition that affects fewer than 200,000 people in the United States. Orphan drug designation provides certain financial incentives to support clinical development and the opportunity for up to seven years of exclusive marketing of the product for the designated orphan indication in the United States if the product is approved for the designated indication.

About Nuvectis Pharma, Inc.

Nuvectis Pharma, Inc. is a biopharmaceutical company focused on developing innovative precision medicines to treat serious diseases with unmet medical needs in oncology. The Company is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator that is currently in a Phase 1b clinical trial for the treatment of platinum-resistant, ARID1a-mutated ovarian cancer and in an investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. The U.S. Food and Drug Administration has granted Fast Track designation and Orphan Drug designation to the NXP800 development program for platinum-resistant ARID1a-mutated ovarian cancer for the treatment of cholangiocarcinoma and ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancer. NXP900 is an oral small molecule inhibitor of the SRC kinase (SFK) family of kinases, including SRC and YES1. NXP900 has a unique mechanism of action as it inhibits both the catalytic and scaffolding functions of the SRC kinase, thereby completely shutting down the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study.

Forward-looking statements

Certain statements in this presentation constitute “forward-looking statements” within the meaning of the U.S. securities laws that involve significant risks and uncertainties. All statements other than statements of historical fact included in this press release are forward-looking statements. Forward-looking statements in this press release can be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “might,” “possibly,” “plan,” “potential,” “predict,” “project,” “seek,” “target,” “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 financing needs. The outcome of the events described in these forward-looking statements is subject to inherent uncertainties, risks, assumptions, market and other conditions and other factors that are difficult to predict and include statements regarding the potential benefits of orphan drug designation for NXP800, the preclinical and Phase 1a data generated to date for NXP800, and clinical expectations for the Phase 1b trial of NXP800, including statements regarding the mechanism of action of NXP800 and its potential ability to become a therapeutic option for the treatment of platinum-resistant ARID1a-mutated ovarian cancer, cholangiocarcinoma and potentially other cancer indications, and the timing of this trial. In addition, certain forward-looking statements are based on assumptions regarding future events that may prove to be incorrect. These and other risks and uncertainties are subject to market and other conditions and are more fully described in the “Risk Factors” section of our Form 10-Q for Q2 2024 and our other public filings with the Securities and Exchange Commission (“SEC”). However, these risks are not exhaustive and new risks and uncertainties arise from time to time, and it is not possible for us to predict all of the risks and uncertainties that could affect the forward-looking statements in this press release or other filings with the SEC. All forward-looking statements included 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 change in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements under the Private Securities Litigation Reform Act of 1995.

Company contact

Ron Bentsour
Chairman, Chief Executive Officer and President
201-614-3151
[email protected]

Contact for media relations

Christopher M. Calabrese
LifeSci Consultant
Phone: 917-680-5608
[email protected]