Drug-drug interaction ("DDI") clinical studies help identify the potential for side effects, or in some cases, reduced therapeutic efficacy, that may be caused by interactions between different drugs.
The market leading epidermal growth factor receptor ("EGFR") and anaplastic lymphoma kinase ("ALK") inhibitors for the treatment of non-small cell lung cancer ("NSCLC") are substrates of the Cytochrome P450 ("CYP") enzyme CYP3A, and therefore their combination with drugs that are strong inducers of CYP3A is to be avoided, or is contraindicated.
As per the International Council for Harmonization ("ICH") M12, topline results from the NXP900 DDI clinical study classify NXP900 as a weak inhibitor of CYP3A; these results support the combination strategy of NXP900 with EGFR/ALK Inhibitors in NSCLC and potentially additional combinations.

Fort Lee, NJ, July 08, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ:NVCT), 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 the successful completion of a clinical DDI study in healthy volunteers for NXP900, supporting NXP900's potential as a combination partner with leading therapies.

Summary of NXP900 Clinical DDI Study

Key Study Objective: To determine whether NXP900 is an inducer of CYP3A, and if so, to classify its induction as weak, moderate or strong as per ICH M12 guidelines
Study Population: 14 healthy volunteers
Key Pharmacokinetics Result: NXP900 increased the concentration of Midazolam, a known CYP3A sensitive substrate, by < 2-fold, classifying it as a weak inhibitor of CYP3A
Key Safety Results: No serious or severe adverse events were reported in this study; diarrhea and non-infection related increases in white blood cell counts were the most common adverse events reported, all mild to moderate in intensity

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "As we're now completing the dose escalation Phase 1a study of NXP900 in patients with advanced cancers, the data generated to date, including the preclinical and mechanistic data, the clinical safety, pharmacokinetics and pharmacodynamics data, and now the clinical DDI data, strongly support advancing NXP900 into the Phase 1b program, set to begin in the coming weeks. In the Phase 1b we plan to test the therapeutic potential of NXP900 as a single agent and in non-chemotherapy based combinations with leading EGFR and ALK drugs in patients that may derive substantial clinical benefit from treatment with NXP900, as their cancers are expected to be sensitive to inhibition of SRC/YES1." Mr. Bentsur concluded, "We believe that NXP900's differentiating properties, mainly the type 1.5 mechanism of action which combines potent and selective inhibition of both the kinase activity and scaffolding properties of the SRC family kinases, should translate into a wide therapeutic window, and we are excited about the future of NXP900."

About Nuvectis Pharma, Inc.

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 is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900's unique mechanism of action enables the inhibition of both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the U.S. 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, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP900, 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 and data regarding the preclinical studies for NXP900 and the Phase 1a data for NXP900 data to date, and the top-line drug-drug interaction study data reported on today, as well as statements regarding NXP900's therapeutic potential as a single agent and in combination with other approved drugs, and the expected timing for the start of the NXP900 Phase 1b program. 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 1Q 2025 Form 10-Q and our other public filings with the U.S. 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.

Company Contact

Ron Bentsur

Chairman, Chief Executive Officer and President

rbentsur@nuvectis.com

Media Relations Contact

Kevin Gardner

LifeSci Advisors

kgardner@lifesciadvisors.com

Nuvectis Pharma Announces Successful Completion of a Drug-Drug Interaction Study in Healthy Volunteers Supporting NXP900's Potential as a Combination Partner with Leading Therapies