Nuvectis Pharma Provides Final Clinical Data Update from the NXP800 Phase 1b Study in Ovarian Cancer and Reports Completion of the NXP900 Phase 1a Dose Escalation Study
Nuvectis Pharma (NASDAQ: NVCT) has announced final clinical data from two key studies. The NXP800 Phase 1b study in ovarian cancer showed mixed results with 2 partial responses and 3 stable diseases among 13 evaluable patients with recurrent, platinum-resistant, ARID1a-mutated ovarian cancer. While demonstrating biological activity, the company will discontinue development in ovarian cancer but explore opportunities in other cancers.
The company also reported successful completion of the NXP900 Phase 1a dose escalation study and drug-drug interaction study. The Phase 1a study evaluated doses from 20 to 300 mg/day, showing mainly mild to moderate gastrointestinal side effects and approximately 90% inhibition of SRC kinase phosphorylation at doses ≥150 mg/day. The Phase 1b program for NXP900, both as monotherapy and in combination with other anti-cancer agents, is expected to begin in the coming weeks.
Nuvectis Pharma (NASDAQ: NVCT) ha annunciato i dati clinici finali di due studi chiave. Lo studio di fase 1b NXP800 nel cancro ovarico ha mostrato risultati misti con 2 risposte parziali e 3 malattie stabili su 13 pazienti valutabili con cancro ovarico ricorrente, resistente al platino e con mutazione ARID1a. Pur dimostrando attività biologica, l'azienda interromperà lo sviluppo nel cancro ovarico ma esplorerà opportunità in altri tipi di tumore.
L'azienda ha inoltre comunicato il completamento con successo dello studio di fase 1a NXP900 di escalation del dosaggio e dello studio di interazione farmacologica. Lo studio di fase 1a ha valutato dosi da 20 a 300 mg/giorno, mostrando principalmente effetti collaterali gastrointestinali da lievi a moderati e circa il 90% di inibizione della fosforilazione della chinasi SRC a dosi ≥150 mg/giorno. Il programma di fase 1b per NXP900, sia in monoterapia sia in combinazione con altri agenti antitumorali, dovrebbe iniziare nelle prossime settimane.
Nuvectis Pharma (NASDAQ: NVCT) ha anunciado datos clínicos finales de dos estudios clave. El estudio de fase 1b NXP800 en cáncer de ovario mostró resultados mixtos con 2 respuestas parciales y 3 enfermedades estables entre 13 pacientes evaluables con cáncer de ovario recurrente, resistente al platino y mutado en ARID1a. Aunque demostró actividad biológica, la compañía descontinuará el desarrollo en cáncer de ovario pero explorará oportunidades en otros tipos de cáncer.
La compañía también informó la finalización exitosa del estudio de escalada de dosis de fase 1a NXP900 y del estudio de interacción farmacológica. El estudio de fase 1a evaluó dosis de 20 a 300 mg/día, mostrando principalmente efectos gastrointestinales leves a moderados y aproximadamente un 90% de inhibición de la fosforilación de la quinasa SRC a dosis ≥150 mg/día. Se espera que el programa de fase 1b para NXP900, tanto en monoterapia como en combinación con otros agentes anticancerígenos, comience en las próximas semanas.
Nuvectis Pharma (NASDAQ: NVCT)가 두 가지 주요 연구의 최종 임상 데이터를 발표했습니다. 난소암에서 진행된 NXP800 1b상 연구에서는 13명의 평가 가능한 재발성 백금 내성 ARID1a 변이 난소암 환자 중 2명의 부분 반응과 3명의 안정 질환이 나타나는 등 혼합된 결과가 나왔습니다. 생물학적 활성을 입증했으나, 회사는 난소암 개발을 중단하고 다른 암종에서의 기회를 모색할 예정입니다.
또한 회사는 NXP900 1a상 용량 증량 연구와 약물 상호작용 연구를 성공적으로 완료했다고 보고했습니다. 1a상 연구에서는 20~300mg/일 용량을 평가했으며, 주로 경증에서 중등도의 위장관 부작용이 나타났고, 150mg/일 이상 용량에서 SRC 키나제 인산화가 약 90% 억제되는 결과를 보였습니다. NXP900의 1b상 프로그램은 단독 요법 및 다른 항암제와 병용하여 향후 몇 주 내에 시작될 예정입니다.
Nuvectis Pharma (NASDAQ : NVCT) a annoncé les données cliniques finales de deux études clés. L'étude de phase 1b NXP800 dans le cancer de l'ovaire a montré des résultats mitigés avec 2 réponses partielles et 3 maladies stables parmi 13 patients évaluables atteints d'un cancer de l'ovaire récidivant, résistant au platine et muté ARID1a. Bien que démontrant une activité biologique, la société va arrêter le développement dans le cancer de l'ovaire mais explorer des opportunités dans d'autres cancers.
La société a également annoncé la réussite de l'étude d'escalade de dose de phase 1a NXP900 et de l'étude d'interaction médicamenteuse. L'étude de phase 1a a évalué des doses de 20 à 300 mg/jour, montrant principalement des effets gastro-intestinaux légers à modérés et environ 90 % d'inhibition de la phosphorylation de la kinase SRC à des doses ≥150 mg/jour. Le programme de phase 1b pour NXP900, en monothérapie et en association avec d'autres agents anticancéreux, devrait débuter dans les semaines à venir.
Nuvectis Pharma (NASDAQ: NVCT) hat finale klinische Daten aus zwei wichtigen Studien bekannt gegeben. Die NXP800 Phase-1b-Studie bei Eierstockkrebs zeigte gemischte Ergebnisse mit 2 partiellen Remissionen und 3 stabilen Verläufen unter 13 auswertbaren Patienten mit rezidivierendem, platinresistentem, ARID1a-mutiertem Eierstockkrebs. Obwohl eine biologische Aktivität nachgewiesen wurde, wird das Unternehmen die Entwicklung bei Eierstockkrebs einstellen, aber Möglichkeiten bei anderen Krebsarten prüfen.
Das Unternehmen berichtete zudem über den erfolgreichen Abschluss der NXP900 Phase-1a-Dosis-Eskalationsstudie sowie der Arzneimittelwechselwirkungsstudie. Die Phase-1a-Studie bewertete Dosen von 20 bis 300 mg/Tag und zeigte überwiegend milde bis moderate gastrointestinale Nebenwirkungen sowie eine etwa 90%ige Hemmung der SRC-Kinase-Phosphorylierung bei Dosen ≥150 mg/Tag. Das Phase-1b-Programm für NXP900, sowohl als Monotherapie als auch in Kombination mit anderen Antikrebsmitteln, soll in den kommenden Wochen starten.
- NXP900 Phase 1a study showed a potentially wide therapeutic window with no dose limiting toxicity up to 300 mg/day
- NXP900 demonstrated robust 90% inhibition of SRC kinase phosphorylation at doses ≥150 mg/day
- Drug-drug interaction study supports potential combinations with EGFR and ALK inhibitors in NSCLC
- Company discontinuing NXP800 development in ovarian cancer due to limited efficacy
- NXP800 showed modest clinical activity with only 2 partial responses out of 13 evaluable patients
- Thrombocytopenia toxicity required switch to intermittent dosing for NXP800
Insights
Nuvectis shows mixed results for NXP800, discontinuing development in ovarian cancer, while advancing NXP900 with a favorable safety profile.
The clinical data from Nuvectis's Phase 1b study of NXP800 in ARID1a-mutated ovarian cancer shows modest efficacy, with just
For NXP900, the completed Phase 1a dose-escalation study reveals promising characteristics: no dose-limiting toxicity was reached even at 300 mg/day, suggesting a potentially wide therapeutic window. The observed
From a development perspective, Nuvectis is making a strategic pivot – acknowledging limitations with NXP800 in ovarian cancer while accelerating NXP900 into Phase 1b studies. This reprioritization reflects rational pipeline management, focusing resources on the asset with the more promising clinical profile. The company's consideration of exploring NXP800 in alternative cancers (endometrial, prostate) with potentially more favorable patient characteristics shows appropriate flexibility in development strategy while maintaining focus on their more promising candidate.
- Available data from 13 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer treated with 75 mg/day in the NXP800 Phase 1b study includes 2 partial responses and 3 stable diseases; thrombocytopenia successfully managed with intermittent dosing schedule; observed clinical activity warrants exploration of potential development opportunities in other cancer types
- NXP900 successfully completed a clinical drug-drug interaction (DDI) study in healthy volunteers and the Phase 1a dose escalation study; initiation of the NXP900 Phase 1b program to evaluate the safety and efficacy of NXP900 as a single agent and in combination with other anti-cancer agents expected in the coming weeks
Fort Lee, NJ, July 31, 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 the final clinical data update from the Phase 1b study of NXP800 in recurrent, platinum resistant, ARID1a-mutated ovarian cancer and reported on the progress towards the initiation of the Phase 1b program for NXP900.
As part of the NXP800 Phase 1b study, 17 patients with recurrent, platinum resistant, ARID1a-mutated ovarian cancer were treated with NXP800 at the target dose of 75 mg/day, administered intermittently or daily, with data available for 13 patients. Overall, treatment resulted in 2 patients achieving partial response (unconfirmed) and 3 achieving stable disease. Thrombocytopenia, a key toxicity identified early in the study, was successfully managed following the switch to intermittent dosing. The company will not pursue further development of NXP800 in ovarian cancer but, in the coming months, will evaluate the feasibility of development opportunities for NXP800 in other cancer types, such as endometrial and prostate cancers, in which the patients’ performance status and other characteristics may allow treatment with NXP800 to be more impactful.
With the recent successful completion of the NXP900 DDI study, which supports the potential combination of NXP900 with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors in non-small cell lung cancer (NSCLC), and now the successful completion of the Phase 1a dose-escalation study, the Company is poised for the start of the Phase 1b study of NXP900, expected in the coming weeks. The Phase 1a dose escalation study evaluated the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of NXP900 in patients with advanced solid tumors (all comers). In this study, a dose range of 20 to 300 mg/day was evaluated and the dose limiting toxicity dose level was not reached. As presented by the study investigators at the 2025 American Association for Cancer Research (AACR) conference, the most common treatment emergent adverse events were mainly gastrointestinal-related and mild to moderate in intensity; systemic exposure to NXP900 increased with increased doses and a robust pharmacodynamic response of approximately
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “While the Phase 1b data provides evidence that NXP800 is biologically active in recurrent, platinum resistant, ARID1a-mutated ovarian cancer, we have decided to focus our near-term efforts on advancing NXP900.” Mr. Bentsur continued, “Recurrent, platinum resistant, ARID1a-mutated ovarian cancer is a rare and very difficult to treat disease with a dismal prognosis, so while any progress in improving outcomes for these patients is important, the time and resources that we believe will be required to further develop NXP800 in this disease setting led us to make this decision. We thank the investigators and study participants for their involvement in the NXP800 Phase 1b study.” Mr. Bentsur added, “That said, we believe that NXP800 is an active agent and in the coming months we will evaluate the feasibility of other opportunities in which NXP800 can potentially demonstrate its anti-cancer activity more profoundly." Mr. Bentsur concluded, "We are excited to be at the cusp of initiating the Phase 1b program for NXP900, which will aim to unleash the significant therapeutic potential that we believe is embedded in NXP900."
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 assets include two clinical-stage drug candidates, NXP900 and NXP800. 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 Phase 1a dose escalation and is progressing toward Phase 1b. NXP800 is an oral small molecule GCN2 activator that has demonstrated anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer, and may be explored in the future in other cancer types. 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 statements 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 preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP900 and NXP800, 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, data and data interpretation. 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 1Q 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
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