Nuvectis Pharma Provides Final Clinical Data Update from the NXP800 Phase 1b Study in Ovarian Cancer and Reports Completion of the NXP900 Phase 1a Dose Escalation Study

Rhea-AI Summary

Nuvectis Pharma (NASDAQ: NVCT) has announced final clinical data from two key studies. The NXP800 Phase 1b study in ovarian cancer showed mixed results with 2 partial responses and 3 stable diseases among 13 evaluable patients with recurrent, platinum-resistant, ARID1a-mutated ovarian cancer. While demonstrating biological activity, the company will discontinue development in ovarian cancer but explore opportunities in other cancers.

The company also reported successful completion of the NXP900 Phase 1a dose escalation study and drug-drug interaction study. The Phase 1a study evaluated doses from 20 to 300 mg/day, showing mainly mild to moderate gastrointestinal side effects and approximately 90% inhibition of SRC kinase phosphorylation at doses ≥150 mg/day. The Phase 1b program for NXP900, both as monotherapy and in combination with other anti-cancer agents, is expected to begin in the coming weeks.

Positive

• NXP900 Phase 1a study showed a potentially wide therapeutic window with no dose limiting toxicity up to 300 mg/day
• NXP900 demonstrated robust 90% inhibition of SRC kinase phosphorylation at doses ≥150 mg/day
• Drug-drug interaction study supports potential combinations with EGFR and ALK inhibitors in NSCLC

Negative

• Company discontinuing NXP800 development in ovarian cancer due to limited efficacy
• NXP800 showed modest clinical activity with only 2 partial responses out of 13 evaluable patients
• Thrombocytopenia toxicity required switch to intermittent dosing for NXP800

• Available data from 13 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer treated with 75 mg/day in the NXP800 Phase 1b study includes 2 partial responses and 3 stable diseases; thrombocytopenia successfully managed with intermittent dosing schedule; observed clinical activity warrants exploration of potential development opportunities in other cancer types
  
  
• NXP900 successfully completed a clinical drug-drug interaction (DDI) study in healthy volunteers and the Phase 1a dose escalation study; initiation of the NXP900 Phase 1b program to evaluate the safety and efficacy of NXP900 as a single agent and in combination with other anti-cancer agents expected in the coming weeks

Fort Lee, NJ, July 31, 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 provided the final clinical data update from the Phase 1b study of NXP800 in recurrent, platinum resistant, ARID1a-mutated ovarian cancer and reported on the progress towards the initiation of the Phase 1b program for NXP900.

As part of the NXP800 Phase 1b study, 17 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer were treated with NXP800 at the target dose of 75 mg/day, administered intermittently or daily, with data available for 13 patients. Overall, treatment resulted in 2 patients achieving partial response (unconfirmed) and 3 achieving stable disease. Thrombocytopenia, a key toxicity identified early in the study, was successfully managed following the switch to intermittent dosing. The company will not pursue further development of NXP800 in ovarian cancer but, in the coming months, will evaluate the feasibility of development opportunities for NXP800 in other cancer types, such as endometrial and prostate cancers, in which the patients’ performance status and other characteristics may allow treatment with NXP800 to be more impactful.

With the recent successful completion of the NXP900 DDI study, which supports the potential combination of NXP900 with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors in non-small cell lung cancer (NSCLC), and now the successful completion of the Phase 1a dose-escalation study, the Company is poised for the start of the Phase 1b study of NXP900, expected in the coming weeks. The Phase 1a dose escalation study evaluated the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of NXP900 in patients with advanced solid tumors (all comers). In this study, a dose range of 20 to 300 mg/day was evaluated and the dose limiting toxicity dose level was not reached. As presented by the study investigators at the 2025 American Association for Cancer Research (AACR) conference, the most common treatment emergent adverse events were mainly gastrointestinal-related and mild to moderate in intensity; systemic exposure to NXP900 increased with increased doses and a robust pharmacodynamic response of approximately 90% inhibition of SRC kinase phosphorylation was elicited at doses of 150 mg/day and higher, suggesting a potentially wide therapeutic window. The final data from the study is expected to be presented at a future medical/scientific conference.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “While the Phase 1b data provides evidence that NXP800 is biologically active in recurrent, platinum resistant, ARID1a-mutated ovarian cancer, we have decided to focus our near-term efforts on advancing NXP900.” Mr. Bentsur continued, “Recurrent, platinum resistant, ARID1a-mutated ovarian cancer is a rare and very difficult to treat disease with a dismal prognosis, so while any progress in improving outcomes for these patients is important, the time and resources that we believe will be required to further develop NXP800 in this disease setting led us to make this decision. We thank the investigators and study participants for their involvement in the NXP800 Phase 1b study.” Mr. Bentsur added, “That said, we believe that NXP800 is an active agent and in the coming months we will evaluate the feasibility of other opportunities in which NXP800 can potentially demonstrate its anti-cancer activity more profoundly." Mr. Bentsur concluded, "We are excited to be at the cusp of initiating the Phase 1b program for NXP900, which will aim to unleash the significant therapeutic potential that we believe is embedded in 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’s assets include two clinical-stage drug candidates, NXP900 and NXP800. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. Its unique mechanism of action enables inhibition of both the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway. NXP900 has completed Phase 1a dose escalation and is progressing toward Phase 1b. NXP800 is an oral small molecule GCN2 activator that has demonstrated anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer, and may be explored in the future in other cancer types. For additional information about Nuvectis Pharma please visit: https://nuvectis.com/.

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 and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP900 and NXP800, 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, data and data interpretation. 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 

FAQ

What were the results of Nuvectis Pharma's (NVCT) NXP800 Phase 1b study in ovarian cancer?

The study showed 2 partial responses and 3 stable diseases among 13 evaluable patients with recurrent, platinum-resistant, ARID1a-mutated ovarian cancer. Due to limited efficacy, the company will not pursue further development in ovarian cancer.

What were the safety findings from the NXP900 Phase 1a dose escalation study?

The study showed mainly mild to moderate gastrointestinal-related side effects, with no dose limiting toxicity reached across doses from 20 to 300 mg/day, suggesting a wide therapeutic window.

What is the next development step for Nuvectis Pharma's NXP900?

Nuvectis plans to initiate the Phase 1b program for NXP900 in the coming weeks, evaluating it both as a single agent and in combination with other anti-cancer agents.

What were the pharmacodynamic results for NXP900 in the Phase 1a study?

NXP900 demonstrated robust pharmacodynamic response with approximately 90% inhibition of SRC kinase phosphorylation at doses of 150 mg/day and higher.

Why is Nuvectis discontinuing NXP800 development in ovarian cancer?

Despite showing biological activity, the company determined that the time and resources required for further development in this rare and difficult-to-treat disease setting did not justify continued pursuit in ovarian cancer.