Nuvectis Pharma Provides Poster Presentation Highlights for NXP900 from the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Nuvectis Pharma (NASDAQ: NVCT) reported poster highlights for NXP900 presented at the 2025 AACR-NCI-EORTC conference. In a Phase 1a dose-escalation program (33 patients), NXP900 given once daily at 20–300 mg showed an acceptable safety profile with mostly Grade 1–2 diarrhea, fatigue and nausea, and elicited a robust pharmacodynamic response at doses ≥150 mg/day. A clinical drug-drug interaction study in healthy volunteers found no induction of key CYP450 enzymes. Preclinical FAT1‑mutant xenograft data showed tumor growth inhibition and YAP1 pathway suppression. The Phase 1b single‑agent study in tumors with YES1, FAT1, NF2 alterations is ongoing (NCT05873686); combination dosing is planned to start in the near term.
Nuvectis Pharma (NASDAQ: NVCT) ha riportato poster highlight per NXP900 presentato alla conferenza AACR-NCI-EORTC 2025. In un programma di dose-escalation di fase 1a (33 pazienti), NXP900 somministrato una volta al giorno a 20–300 mg ha mostrato un profilo di sicurezza accettabile con principalmente diarrea di grado 1–2, affaticamento e nausea, e ha suscitato una robusta risposta farmacodinamica a dosi ≥150 mg/giorno. Uno studio di interazione farmacologica tra farmaco e farmaco in soggetti sani non ha trovato induzione di enzimi chiave del CYP450. Dati preclinici FAT1-mutant xenograft hanno mostrato inibizione della crescita tumorale e soppressione della via YAP1. Lo studio di fase 1b con solo agente in tumori con alterazioni YES1, FAT1, NF2 è in corso (NCT05873686); è previsto iniziare la somministrazione in combinazione nel breve termine.
Nuvectis Pharma (NASDAQ: NVCT) presentó pósteres destacados para NXP900 en la conferencia AACR-NCI-EORTC 2025. En un programa de escalado de dosis de fase 1a (33 pacientes), NXP900 administrado una vez al día a 20–300 mg mostró un perfil de seguridad aceptable con diarrea, fatiga y náuseas predominantemente grado 1–2, y logró una respuesta farmacodinámica robusta a dosis ≥150 mg/día. Un estudio clínico de interacción fármaco-fármaco en voluntarios sanos encontró que no hubo inducción de enzimas clave del CYP450. Datos preclínicos FAT1-mutant xenograft mostraron inhibición del crecimiento tumoral y suppressión de la vía YAP1. El estudio de fase 1b en monoterapia para tumores con alteraciones YES1, FAT1, NF2 está en curso (NCT05873686); se planea iniciar dosis en combinación a corto plazo.
Nuvectis Pharma (NASDAQ: NVCT)은 2025 AACR-NCI-EORTC 학회에서 발표된 NXP900의 포스터 하이라이트를 보고했습니다. 1상 1a 단계의 용량 증가 프로그램(33명)에서 NXP900을 매일 20–300 mg으로 투여했을 때 안전성 프로필은 대체로 1–2등급의 설사, 피로, 메스꺼움으로 수용 가능했고, 용량 ≥150 mg/일에서 강한 약력학 반응을 유발했습니다. 건강한 자원자를 대상으로 한 약물-약물 상호작용 임상 연구에서는 주요 CYP450 효소의 유도가 관찰되지 않았습니다. FAT1 변이 암종의 전임상 FAT1-mutant 이종이식 데이터는 종양 성장 억제와 YAP1 경로 억제를 보였습니다. YES1, FAT1, NF2 변화가 있는 종양에서의 단일제 1b 단계 연구는 진행 중(NCT05873686); 조합 용량 투여는 곧 시작될 예정입니다.
Nuvectis Pharma (NASDAQ: NVCT) a présenté des points forts de poster pour NXP900 présentés à la conférence AACR-NCI-EORTC 2025. Dans un programme d’escalade de dose de phase 1a (33 patients), NXP900 administré une fois par jour à 20–300 mg a montré un profil de sécurité acceptable avec principalement des diarrhées de grade 1–2, de la fatigue et des nausées, et a suscité une réponse pharmacodynamique robuste à des doses ≥150 mg/jour. Une étude clinique d’interaction médicament-médicament chez des volontaires sains n’a trouvé aucune induction des enzymes clés du CYP450. Des données précliniques FAT1-mutant xenograft ont montré une inhibition de la croissance tumorale et une suppression de la voie YAP1. L’étude de phase 1b en monothérapie chez des tumeurs présentant des altérations YES1, FAT1, NF2 est en cours (NCT05873686) ; une dose de combinaison est prévue de commencer dans un avenir proche.
Nuvectis Pharma (NASDAQ: NVCT) berichtete Poster-Highlights für NXP900, vorgestellt auf der AACR-NCI-EORTC-Konferenz 2025. In einem Phase-1a-Dosis-Eskalationsprogramm (33 Patienten) zeigte NXP900, gegeben einmal täglich mit 20–300 mg, ein akzeptables Sicherheitsprofil mit überwiegend Grad-1–2-Diarrhö, Müdigkeit und Übelkeit, und rief eine robuste pharmakodynamische Reaktion bei Dosen ≥150 mg/Tag hervor. Eine klinische Wechselwirkungsstudie (Drug-Drug Interaction) in gesunden Freiwilligen ergab keine Induktion wichtiger CYP450-Enzyme. Preklinische FAT1-Mutant Xenograft-Daten zeigten eine Hemmung des Tumorwachstums und eine Unterdrückung des YAP1-Weges. Die Phase-1b-Einzelwirkstoff-Studie bei Tumoren mit YES1-, FAT1-, NF2-Veränderungen läuft (NCT05873686); eine Kombinationsdosierung ist in naher Zukunft geplant.
Nuvectis Pharma (بورصة ناسداك: NVCT) قامت بتقديم ملخصات ملصقية لـ NXP900 في مؤتمر AACR-NCI-EORTC 2025. في برنامج تعتيم جرعات من المرحلة 1a (33 مريضاً)، أعطي NXP900 مرة يومياً بجرعات 20–300 mg، وأظهر ملف سلامة مقبول مع غالباً إسهال من الدرجة 1–2، تعب وغثيان، وأثار استجابة فارماكوديناميكية قوية عند الجرعات ≥150 mg/اليوم. دراسة تفاعل دواء-دواء سريرية في متطوعين أصحاء وجدت عدم وجود تحفيز لإنزيمات CYP450 الرئيسية. البيانات قبل السريرية FAT1-mutant في نماذج زِنَاجية أظهرت تثبيط نمو الورم وقمع مسار YAP1. الدراسة من المرحلة 1b كعلاج واحد في أورام تحتوي تغييرات YES1 وFAT1 وNF2 جارية (NCT05873686)؛ من المخطط البدء في جرعات الجمع في القريب العاجل.
Nuvectis Pharma（纳斯达克股票代码：NVCT）公布了在2025年AACR-NCI-EORTC大会上展示的NXP900海报要点。在1a期药物剂量爬坡计划（33名患者）中，NXP900每日一次给药，剂量为20–300 mg，显示出可接受的安全性特征，主要为1–2级腹泻、疲劳和恶心，并在剂量≥150 mg/日时引发了强烈的药效动力学反应。健康志愿者的药物-药物相互作用临床研究发现未引起关键CYP450酶的诱导。前临床 FAT1 突变异种异种移植数据显示了肿瘤生长抑制和 YAP1 通路抑制。针对 YES1、FAT1、NF2 改变的肿瘤的阶段1b单药研究正在进行中（NCT05873686）；计划在不久的将来开始联合给药。
- Phase 1a safety acceptable in 33 patients
- Robust pharmacodynamic response at doses ≥150 mg/day
- No CYP450 induction in clinical drug‑drug interaction study
- Most common adverse events were diarrhea, fatigue and nausea (mostly Grade 1–2)
- Phase 1a clinical dataset limited to 33 patients; broader efficacy not yet shown
Insights
Phase 1a shows tolerable safety, clear pharmacodynamic activity at ≥150 mg/day, and no CYP450 induction—positive early clinical validation.
At the mechanistic level, the data report an acceptable safety profile in 33 advanced‑cancer patients across 20–300 mg/day and a robust pharmacodynamic response at doses ≥150 mg/day, which supports target engagement for NXP900 as an SRC/YES1 inhibitor. The reported lack of CYP450 induction in healthy volunteers directly enables combination strategies because it reduces the risk of drug‑drug interactions that can complicate dosing.
Key dependencies and risks include that these are Phase 1a and preclinical signals only; safety events were mainly Grade 1–2 but broader tolerability and efficacy remain unproven in larger, biomarker‑selected cohorts. The company links its biomarker selection (YES1, FAT1, NF2 and other alterations) to preclinical xenograft efficacy in FAT1‑mutant models, which supports the Phase 1b monotherapy path but does not guarantee clinical benefit.
Concrete items to watch: readouts from the single‑agent Phase 1b cohort and the planned combination portion initiation, plus any objective response or durability data and expanded safety findings; the Phase 1b program identifier is
Fort Lee, NJ, Oct. 27, 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 highlights for NXP900 poster presentations that took place last week at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “The results from the Phase1a dose escalation and clinical drug-drug interaction studies are important building blocks in NXP900’s clinical development journey to hopefully become a best-in-class SRC/YES1 inhibitor with broad clinical applications.” Mr. Bentsur continued, “The safety profile from the Phase 1a, and, importantly, the deep and sustained pharmacodynamic response in clinically relevant doses, provide a strong proof of mechanism consistent with the early research work that demonstrated NXP900’s unique mechanism of action and target selectivity. Moreover, the preclinical data presented at the conference further solidifies the rationale for the biomarker patient selection strategy being implemented in the Phase 1b program.” Mr. Bentsur concluded,” With the single agent portion of the Phase 1b program now underway, we look forward to the initiation of the combination portion in the near term and start providing clinical data updates as the program proceeds.”
NXP900 Clinical Safety, PKPD and CYP450 Interactions (Link to Poster)
- In 33 patients with advanced cancers, the safety of NXP900 administered once daily at doses ranging from 20 to 300 mg/day was acceptable, with diarrhea, fatigue and nausea being the most common adverse events, mostly reported as Grade 1-2.
- XP900 elicited a robust pharmacodynamic response at doses ≥150 mg/day.
- In a clinical drug-drug interaction study in healthy volunteers NXP900 did not induce the activity of key CYP450 enzymes, a key consideration for the combination strategy.
- A phase 1b study of NXP900 as monotherapy in patients with advanced solid tumors with YES1, FAT1, NF2 and other genomic alterations is ongoing (NCT05873686).
NXP900 Inhibits Tumor Growth in FAT1-mutated Xenograft Models (Link to Poster)
- NXP900 inhibits YAP1 nuclear localization and cell proliferation at low nM concentration in FAT1-mutated squamous carcinoma cells.
- NXP900 inhibits tumor growth in FAT1-mutated squamous xenograft models.
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 lead program, 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 a Phase 1a dose escalation study and is being evaluated in a Phase 1b program. The Company is also considering next steps for NXP800, an oral small molecule GCN2 activator that has demonstrated anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer. 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 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 but not limited to the expected impact of the new Board appointment, preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP900 and the timing and data expectations for the NXP900 Phase 1b study. The outcomes 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. 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 may also be subject to market and other conditions and described more fully in the section titled "Risk Factors" in our Q2 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 Phase 1a safety results did Nuvectis report for NXP900 (NVCT) on October 27, 2025?
At what dose did NXP900 show a robust pharmacodynamic response in the Phase 1a NVCT study?
Did the NXP900 drug‑drug interaction study for NVCT show CYP450 induction?
What preclinical efficacy did Nuvectis present for NXP900 at the 2025 conference?
What is the status of the NXP900 Phase 1b program (NVCT) and which genomics does it target?
