Phase 1a dose-escalation study data update: treatment with NXP900 resulted in exposure levels leading to robust pharmacodynamic responses across a range of tolerated doses; NXP900 has an acceptable safety profile, dose limiting toxicity dose level has not been identified in doses up to 250 mg/day
Preclinical posters strengthen the NXP900 clinical development strategy as single agent in biomarker-targeted cancers and in combination with market leading therapies to overcome resistance in NSCLC
Fort Lee, NJ, April 29, 2025 (GLOBE NEWSWIRE) — 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 provided poster presentation highlights for NXP900 from the 2025 American Association for Cancer Research Meeting (2025 AACR). These posters highlight key data supporting the rationale for the Phase 1b program in biomarker-selected cancers as a single agent, and in combination with market leading therapies to overcome treatment resistance in non-small cell lung cancer (NSCLC). The posters are available on the Company’s website.
NXP900 Phase 1a highlights
- Twenty-nine patients with advanced cancers (not selected for target biomarkers, i.e., “all comers”) were treated with single agent NXP900 at doses ranging from 20 to 250 mg/day. In these patients, the median age was 62 years (range: 36-89), 62% were males, 83% had an ECOG performance score of 1, and the median number of prior therapies was 5.
- The most common treatment emergent adverse events were fatigue, diarrhea, nausea, abdominal pain, dyspnea and vomiting, mostly reported as Grade 1-2. The dose limiting toxicity (DLT) dose level has not been identified in doses up to 250 mg/day.
- Systemic exposure increased with increased doses of NXP900, achieving clinically relevant concentrations starting at the 150 mg/day dose, as demonstrated by a robust pharmacodynamic response. Maximal level of SRC inhibition in patient samples after a single dose of NXP900 exceeded 90%.
Three preclinical posters highlight potential use of NXP900 in NSCLC
- As a single agent, NXP900 potently inhibited YAP1 nuclear localization and the proliferation of YES1/YAP1-amplified NSCLC cells in vitro and induced substantial tumor growth inhibition in an in vivo model of YES1-amplified NSCLC. Together, these are the data that demonstrate the relevance of inhibiting NXP900’s direct target, the SRC kinase family member YES1, in NSCLC, and provide the rationale to target NSCLC and potentially other cancers with Hippo pathway inactivating alterations (YAP1, FAT1, NF2, TAZ).
- As a combination partner, the addition of NXP900 to market leading epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) kinase inhibitors resulted in reversal of resistance to the anti-EGFR and anti-ALK agents, providing the scientific rationale for the clinical development of NXP900 in these settings, as acquired resistance remains an unmet clinical need in NSCLC.
Phase 1b program
The Phase 1b portion of the single agent study is expected to commence shortly after the conclusion of the dose escalation phase, in which patients with advanced cancers with YES1 gene amplifications and hippo pathway alterations will be included. Another objective of the Phase 1b program is to evaluate NXP900 in combination with existing market-leading therapies for the treatment of resistant NSCLC.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented, “This year’s AACR presentations mark an important milestone in the development of NXP900. As new preclinical data continue to unlock the unique potential of NXP900 as a single agent and as a combination partner, we revealed, for the first time, preliminary clinical data from the ongoing Phase 1a dose escalation clinical trial that provide a link between the existing preclinical mechanistic data and NXP900’s potential in the clinic.” Mr. Bentsur concluded, “with the ability to induce a robust pharmacodynamic response and an acceptable safety profile, we believe that the therapeutic window of NXP900 puts it in a favorable position to demonstrate clinical efficacy in target patients, which is the primary objective of the Phase 1b program that will commence in the coming months. We are excited about the potential of NXP900 as its clinical profile continues to evolve.”
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 federal securities laws, which statements are subject to substantial risks and uncertainties, including statements regarding the expected and intended use of proceeds from the offering. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, including statements regarding the intended. 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 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 studies for NXP900 and statements regarding NXP900’s therapeutic potential and the expected timing for the completion of the Phase 1a dose-escalation study and 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 2024 Form 10-K and our other public filings 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.
Company Contact
Ron Bentsur
Chairman, Chief Executive Officer and President
[email protected]
Media Relations Contact
Kevin Gardner
LifeSci Advisors
[email protected]
