Nuvectis Pharma’s New Phase 1b Trial Targets a Major Lung Cancer Bottleneck (NASDAQ: NVCT)

WSW, NY, December 17th, 2025, FinanceWire

Resistance remains one of the biggest unsolved problems in modern cancer treatment, and nowhere is that more evident than in lung cancer. AstraZeneca’s Tagrisso has become the gold standard for patients with EGFR-mutated non-small cell lung cancer, generating more than $6 billion in annual sales and delivering meaningful clinical benefit. Yet despite strong initial responses, most patients eventually see their disease progress as tumors adapt and develop resistance.

That biological reality is now being directly tested by Nuvectis Pharma in lung cancer (NASDAQ: NVCT).

On December 17, Nuvectis announced the initiation of a Phase 1b clinical study evaluating its investigational drug NXP900 in combination with osimertinib, the active ingredient in Tagrisso. The study is enrolling patients with EGFR-mutated lung cancer whose disease initially responded to Tagrisso but later developed acquired resistance, a group that often faces limited treatment options depending on the underlying resistance mechanism.

Rather than attempting to displace a blockbuster therapy in EGFR-mutated lung cancer, Nuvectis is pursuing a complementary strategy. At the same time, the company continues to evaluate NXP900 as a single agent in other settings, reflecting a broader, biology-driven development approach.

Scientific literature has shown that resistance to EGFR inhibitors can, in certain tumors, be driven by activation of alternative signaling pathways involving SRC family kinases, including SRC and YES1. These pathways can allow tumors to bypass EGFR blockade and continue growing. Nuvectis’ thesis is that shutting down this escape route could help extend the benefit patients receive from Tagrisso.

NXP900 is designed to inhibit SRC family kinases, including SRC and YES1, through a differentiated mechanism that targets both their catalytic activity and their non-catalytic scaffolding functions — a feature that has historically proven difficult for prior drugs in this class. Earlier attempts to block SRC signaling in solid tumors often struggled to demonstrate meaningful clinical efficacy, limiting their impact despite acceptable tolerability.

Preclinical studies provided the rationale to advance NXP900 into combination testing. In laboratory models, tumors treated with EGFR inhibitors alone initially shrank but later rebounded as SRC-mediated resistance pathways became activated. When NXP900 was added, tumor suppression was deeper and more durable, supporting the hypothesis that dual-pathway inhibition could meaningfully alter disease progression.

Of course, translating results from the lab into real-world patient benefit remains the central challenge. That is why the newly initiated Phase 1b study is focused on evaluating safety and early signs of clinical activity rather than definitive efficacy. Importantly, early clinical experience with NXP900 as a single agent has suggested the drug is generally well tolerated, addressing a hurdle that has complicated prior SRC-targeting approaches.

The combination study builds on Nuvectis’ broader Phase 1b program, which followed the successful completion of a Phase 1a dose-escalation trial and a clinical drug-drug interaction study in healthy volunteers. Earlier this year, the company outlined plans to explore both single-agent and combination strategies in tumors driven by SRC and related pathways. The December announcement confirms that those plans are now being executed, with Tagrisso selected as the first combination partner.

Clinician interest in the approach has been growing. Resistance to EGFR inhibitors remains a persistent frustration in lung cancer care, and oncologists have long sought oral combination strategies that could delay progression without significantly worsening patients’ quality of life. A pill-based regimen, if successful, could offer a differentiated alternative to current post-resistance treatment approaches.

From a market perspective, Nuvectis remains a micro-cap company operating in the shadow of a multibillion-dollar drug. That imbalance helps frame the asymmetric nature of the opportunity, particularly given the commercial importance of EGFR-mutated non-small cell lung cancer, where resistance remains a central limitation despite years of innovation. If NXP900 were to demonstrate an ability to meaningfully delay or overcome resistance, it would position the company at a critical inflection point in one of oncology’s most valuable markets. With cash expected to fund operations into the third quarter of 2027, Nuvectis has the runway to advance both its single-agent and combination programs without near-term financing pressure.

Recent insider activity has added to investor interest, with company leadership reporting open-market share purchases in recent weeks, signaling confidence as the clinical program advances.

While early-stage biotech development always carries uncertainty, the initiation of the NXP900–Tagrisso combination study marks a meaningful inflection point for Nuvectis. The company has moved beyond theory and preclinical promise and into a defined clinical test of its resistance-targeting strategy, directly in the patient population where the need is greatest.

As the program advances, upcoming clinical updates over the next several years will be critical in determining whether Nuvectis’ approach can deliver on its promise. For now, the company has taken a clear step forward, positioning itself as a small player aiming to tackle one of oncology’s most persistent challenges — and beginning to attract the market’s attention as it does so.

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Recent News Highlights from Nuvectis Pharma

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

Nuvectis Pharma to Host a Virtual Key Opinion Leader Meeting to Discuss the NXP900 Phase 1b Program in Advanced Solid Tumors, Including the Combination with Osimertinib in NSCLC

Nuvectis Pharma Provides Poster Presentation Highlights for NXP900 from the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

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