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Nuvectis Pharma Announces the Initiation of the Phase 1b Study of NXP900 in Combination with Osimertinib in Patients with NSCLC

1. Nuvectis Pharma initiates Phase 1b study of NXP900 with osimertinib. 2. NXP900 targets resistant EGFRmut+ NSCLC patients, enhancing treatment options. 3. CEO highlights significant potential in combining NXP900 and osimertinib. 4. 2026 expected to deliver multiple key data readouts from ongoing studies.

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Why Bullish?

The initiation of Phase 1b study may enhance NVCT's market position, reminiscent of other biopharmaceutical advancements. For instance, companies announcing similar clinical trials often experience positive market responses.

How important is it?

The article details a significant development in Nuvectis' pipeline, directly impacting investor sentiment and potential future revenues.

Why Long Term?

Success in clinical trials typically leads to sustained investor interest, as observed in companies like Novartis and their extended pipeline outcomes.

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Nuvectis Pharma Initiates Phase 1b Study of NXP900 in Combination with Osimertinib for NSCLC

Fort Lee, NJ, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical-stage biopharmaceutical company specializing in innovative precision medicines for oncology, has announced the launch of a Phase 1b study. This clinical trial will investigate NXP900 in combination with osimertinib for patients diagnosed with EGFRmut+ non-small cell lung cancer (NSCLC).

About NXP900 and the Combination Study

NXP900 is an oral small molecule drug candidate specifically designed to inhibit SRC and YES1 kinases. Osimertinib, branded as Tagrisso® and marketed by AstraZeneca, is a widely utilized third-generation EGFR inhibitor, particularly effective for NSCLC patients as both a standalone treatment and in combination therapies.

Research indicates that the SRC/YES1 pathway activation contributes to resistance against EGFR inhibitor therapies, thereby underlining the importance of this study.

Phase 1b Study Details

The Phase 1b program follows the successful completion of a Phase 1a dose escalation study that evaluated the safety and tolerability of NXP900 as a monotherapy. This ongoing study assesses patients with specific genetic profiles suitable as either direct or dependent targets of NXP900. Additionally, the tumor types included in the trial are selected based on the prevalence of relevant genetic alterations.

Today's announcement marks the beginning of the first combination study of NXP900 under the Phase 1b program, combining it with osimertinib specifically for EGFRmut+ NSCLC patients.

Eligibility Requirements for Patients

Participants in this study must have unresectable, metastatic, or locally advanced EGFRmut+ NSCLC and must have previously responded to osimertinib in either the first or second-line treatment settings. Those with tumors containing EGFR mutations that lead to resistance against osimertinib, or those possessing additional oncogenic drivers unrelated to EGFR mutation, will not qualify for this trial.

Leadership Insights

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, stated, "We are pleased to announce the initiation of the NXP900 plus osimertinib combination study, as we continue to advance the NXP900 clinical program and unlock NXP900’s promising therapeutic potential.” He further emphasized the known benefits of osimertinib for patients with EGFRmut+ NSCLC and expressed confidence that the combination with NXP900 could extend therapeutic advantages to those who have developed resistance to osimertinib.

Bentsur added, “We expect 2026 to be an exciting year with multiple data readouts from both the single agent and combination studies, and we look forward to providing updates from the program throughout the year."

Overview of Nuvectis Pharma

Nuvectis Pharma is dedicated to developing groundbreaking precision therapies aimed at treating serious oncological conditions that are currently underserved. The company’s portfolio includes two clinical-stage candidates: NXP900 and NXP800. While NXP900 targets SRC Family of Kinases (SFK), NXP800 is a GCN2 activator with demonstrated efficacy in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer.

For more information, visit Nuvectis Pharma.

Forward-Looking Statements

This press release contains forward-looking statements under U.S. federal securities laws, which carry inherent risks and uncertainties. These statements may encompass anticipated timelines, future outcomes, and potential performance metrics concerning NXP900 and its combination with osimertinib.

Forward-looking statements can be recognized by terms such as "anticipate," "believe," "expect," or "project." However, actual outcomes may vary significantly due to various market conditions, uncertainties, and operational factors. Interested parties are advised to refer to the "Risk Factors" section in our Q3 2025 Form 10-Q and other public filings with the U.S. SEC for more details.

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