Nuvectis Pharma Initiates NXP900 and Osimertinib Combination Study
Nuvectis Pharma announced the initiation of the Phase 1b study of NXP900 in combination with osimertinib in patients with EGFRmut+ NSCLC. NXP900, an oral small molecule drug candidate, is a potent inhibitor of the SRC and YES1kinases. The brand name for Osimertinib is Tagrisso, marketed by Astra Zeneca. Tagrisso, a 3rd generation EGFR inhibitor is broadly used in patients with NSCLCmut+ as single agent or in combination with chemotherapy as a first or later line of therapy. It has been described in the scientific literature that activation of the SRC/YES1 pathway drives resistance to EGFR inhibitor therapy in EGFRmut+ NSCLC. Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented, "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." Mr. Bentsur added, "The clinical benefit and improved outcomes afforded by osimertinib to patients with EGFRmut+ NSCLC are well known, and we believe, based on extensive medical and scientific literature and proof of concept experiments done by us and others, that a combination with NXP900 has the potential to extend these benefits in patients who acquired resistance to osimertinib, using an all oral combination of osimertinib and NXP900."
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- Clinical Study Initiation: Nuvectis Pharma has announced the initiation of a Phase 1b clinical study of NXP900 in combination with osimertinib, targeting patients with EGFR-mutant non-small cell lung cancer (NSCLC), marking a significant advancement in the company's precision oncology efforts.
- Drug Mechanism: NXP900 is an oral small molecule that effectively inhibits SRC and YES1 kinases, addressing resistance mechanisms in EGFR-mutant patients, which could provide new therapeutic options and enhance clinical efficacy.
- Patient Selection Criteria: The study focuses on patients with unresectable metastatic or locally advanced EGFR-mutant NSCLC who have previously responded to osimertinib, ensuring the relevance and potential effectiveness of the study results, which may provide critical data for future treatment strategies.
- Future Outlook: Nuvectis anticipates that 2026 will be a pivotal year with multiple data readouts from both monotherapy and combination studies, further advancing the clinical development of NXP900 and strengthening the company's competitive position in the oncology market.
- Clinical Study Launch: Nuvectis Pharma announces the initiation of a Phase 1b clinical study combining NXP900 with osimertinib, aimed at providing new treatment options for patients with EGFR-mutant non-small cell lung cancer, marking the company's ongoing innovation in oncology.
- Drug Mechanism: NXP900 is an oral small molecule that effectively inhibits SRC and YES1 kinases, targeting known mechanisms of resistance to EGFR inhibitors, which may enhance clinical efficacy and patient outcomes.
- Patient Selection Criteria: The study focuses on patients with unresectable metastatic or locally advanced EGFR-mutant NSCLC who have previously responded to osimertinib, ensuring the relevance and effectiveness of the study results.
- Future Outlook: Nuvectis CEO Ron Bentsur stated that 2026 is expected to be an exciting year with multiple data readouts from both monotherapy and combination studies, further advancing the clinical development of NXP900.

NXP900 Clinical Trials: Nuvectis Pharma has initiated the Phase 1b program for NXP900, focusing on its efficacy in advanced cancers, with the combination therapy expected to start by year-end after successful completion of the Phase 1a study.
Financial Overview: The company reported a cash balance of $35.4 million as of September 30, 2025, an increase from the previous year, but also noted a net loss of $7.5 million for the third quarter, attributed to milestone expenses and clinical study costs.
Emerging Clinical Profile: NXP900 has shown promising pharmacodynamic responses in clinical studies, supporting its potential as a single agent and in combination therapies to overcome drug resistance in cancer treatment.
Future Outlook: Nuvectis aims to leverage its cash position and operational efficiency to achieve key milestones in the NXP900 program, while also considering next steps for another candidate, NXP800, targeting specific cancer types.

NXP900 Drug Development: Nuvectis Pharma's lead drug candidate, NXP900, has successfully completed Phase 1a studies in patients with advanced solid tumors and is set to initiate the Phase 1b program soon. The company also plans to explore NXP800 for potential use in various cancer types.
Financial Position Update: As of June 30, 2025, Nuvectis reported a cash position of approximately $39 million following a recent share acquisition, despite a net loss increase to $6.3 million compared to the previous year, primarily due to research and development expenses.

NXP800 Phase 1b Study Results: The Phase 1b study of NXP800 in patients with recurrent, platinum-resistant, ARID1a-mutated ovarian cancer showed 2 partial responses and 3 stable diseases; however, further development in this area will not continue as the company plans to explore other cancer types for NXP800.
NXP900 Development Progress: Nuvectis Pharma is set to initiate the Phase 1b program for NXP900 after successfully completing a drug-drug interaction study and a Phase 1a dose escalation study, which demonstrated safety and potential efficacy in advanced solid tumors.

Phase 1a Study Results: NXP900 demonstrated robust pharmacodynamic responses and an acceptable safety profile in a Phase 1a dose-escalation study involving 29 patients with advanced cancers, with no identified dose-limiting toxicity at doses up to 250 mg/day.
Future Development Plans: Preclinical data supports the use of NXP900 as a single agent and in combination therapies for NSCLC, with plans to initiate a Phase 1b program targeting patients with YES1 gene amplifications and hippo pathway alterations shortly after completing the current study phase.




