Nuvectis Pharma Announces the Initiation of the Phase 1b Program for NXP900
Nuvectis Pharma (NASDAQ: NVCT) has announced the initiation of its Phase 1b program for NXP900, following successful completion of dose escalation and drug-drug interaction studies. The program consists of two components: a single-agent study evaluating NXP900 in patients with specific genetic alterations, and a combination study with EGFR and ALK inhibitors in NSCLC patients who developed treatment resistance.
The single-agent component targets patients with YES1 amplification, FAT1 mutations in NSCLC, NF2 mutations in mesothelioma and renal cancer, and other solid tumors with relevant Hippo Pathway alterations. The combination study, expected to start later in 2025, will focus on NSCLC patients who developed resistance to existing treatments.
Nuvectis Pharma (NASDAQ: NVCT) ha annunciato l'avvio del programma di Fase 1b per NXP900, a seguito del completamento con successo delle sperimentazioni di escalation di dose e degli studi sulle interazioni farmacologiche. Il programma comprende due parti: uno studio in monoterapia che valuta NXP900 in pazienti con specifiche alterazioni genetiche, e uno studio in combinazione con inibitori di EGFR e ALK nei pazienti con NSCLC che hanno sviluppato resistenza ai trattamenti.
La componente in monoterapia 猫 rivolta a pazienti con amplificazione di YES1, mutazioni di FAT1 nel NSCLC, mutazioni di NF2 nel mesotelioma e nel carcinoma renale, e ad altri tumori solidi con alterazioni rilevanti della via Hippo. Lo studio in combinazione, previsto pi霉 avanti nel 2025, si concentrer脿 sui pazienti con NSCLC che hanno acquisito resistenza alle terapie correnti.
Nuvectis Pharma (NASDAQ: NVCT) ha anunciado el inicio de su programa de Fase 1b para NXP900, tras completar con 茅xito los estudios de escalado de dosis y de interacci贸n f谩rmaco-f谩rmaco. El programa consta de dos partes: un estudio en monoterapia que eval煤a NXP900 en pacientes con alteraciones gen茅ticas espec铆ficas, y un estudio combinado con inhibidores de EGFR y ALK en pacientes con NSCLC que han desarrollado resistencia al tratamiento.
La rama en monoterapia est谩 dirigida a pacientes con amplificaci贸n de YES1, mutaciones en FAT1 en NSCLC, mutaciones en NF2 en mesotelioma y c谩ncer renal, y otros tumores s贸lidos con alteraciones relevantes en la v铆a Hippo. El estudio combinado, que se espera comenzar m谩s adelante en 2025, se centrar谩 en pacientes con NSCLC que han desarrollado resistencia a las terapias existentes.
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雼弲鞖旊矔 鞐瓣惮电� 牍勳唽靹疙彫韽愳晹(NSCLC)鞐愳劀鞚� YES1 歃濏彮, FAT1 氤�鞚�, 欷戫敿膦� 氚� 鞁犾灔鞎旍棎靹滌潣 NF2 氤�鞚�, 攴鸽Μ瓿� 頌堩彫(Hippo) 瓴诫 甏�霠� 氤�鞚措ゼ 臧�歆� 旮绊儉 瓿犿槙鞎� 頇橃瀽毳� 雽�靸侅溂搿� 頃╇媹雼�. 氤戩毄 鞐瓣惮电� 2025雲� 頉勲皹鞐� 鞁滌瀾霅� 鞓堨爼鞚措┌, 旮办〈 旃橂鞐� 雮挫劚鞚� 須嶋摑頃� NSCLC 頇橃瀽霌れ潉 欷戩嫭鞙茧 歆勴枆霅� 瓴冹瀰雼堧嫟.
Nuvectis Pharma (NASDAQ: NVCT) a annonc茅 le lancement de son programme de phase 1b pour NXP900, apr猫s avoir men茅 脿 bien les 茅tudes d'escalade de dose et d'interactions m茅dicamenteuses. Le programme comprend deux volets : une 茅tude en monoth茅rapie 茅valuant NXP900 chez des patients porteurs d'alt茅rations g茅n茅tiques sp茅cifiques, et une 茅tude en combinaison avec des inhibiteurs d'EGFR et d'ALK chez des patients atteints de NSCLC ayant d茅velopp茅 une r茅sistance aux traitements.
Le volet en monoth茅rapie cible les patients pr茅sentant une amplification de YES1, des mutations de FAT1 dans le NSCLC, des mutations de NF2 dans le m茅soth茅liome et le cancer du rein, ainsi que d'autres tumeurs solides pr茅sentant des alt茅rations pertinentes de la voie Hippo. L'茅tude en combinaison, dont le d茅marrage est pr茅vu plus tard en 2025, se focalisera sur les patients atteints de NSCLC ayant acquis une r茅sistance aux th茅rapies existantes.
Nuvectis Pharma (NASDAQ: NVCT) hat den Start seines Phase-1b-Programms f眉r NXP900 bekanntgegeben, nachdem Dosis-Eskalations- und Wechselwirkungsstudien erfolgreich abgeschlossen wurden. Das Programm umfasst zwei Teile: eine Monotherapie-Studie, die NXP900 bei Patienten mit bestimmten genetischen Ver盲nderungen untersucht, und eine Kombinationsstudie mit EGFR- und ALK-Inhibitoren bei NSCLC-Patienten, die eine Therapieresistenz entwickelt haben.
Die Monotherapie-Komponente richtet sich an Patienten mit YES1-Amplifikation, FAT1-Mutationen im NSCLC, NF2-Mutationen beim Mesotheliom und Nierenkrebs sowie an andere solide Tumoren mit relevanten Ver盲nderungen im Hippo-Signalweg. Die Kombinationsstudie, die sp盲ter im Jahr 2025 starten soll, wird sich auf NSCLC-Patienten mit erworbener Therapieresistenz konzentrieren.
- Successful completion of Phase 1a dose escalation and drug-drug interaction studies
- Company is well-funded to execute NXP900 development plans
- Recent share acquisition by healthcare-specialized institutional investor shows confidence in the program
- NXP900 represents potential 'pipeline in a pill' opportunity addressing multiple cancer types
- Phase 1b combination study component has not yet started
- Clinical efficacy data still pending from Phase 1b program
Insights
Nuvectis advances NXP900 to Phase 1b trials targeting specific cancer genetic alterations, representing promising pipeline expansion with dual mechanism potential.
Nuvectis has strategically designed their Phase 1b program for NXP900 to target specific genetic vulnerabilities in cancer, demonstrating a sophisticated precision medicine approach. The program consists of two components: a single-agent arm targeting YES1 amplification and Hippo Pathway alterations (including FAT1 and NF2 mutations), and a combination arm with EGFR/ALK inhibitors in non-small cell lung cancer (NSCLC) patients who developed resistance to these treatments.
The single-agent component's focus on specific genetic alterations reflects a biomarker-driven strategy that significantly increases the probability of observing clinical responses compared to unselected patient populations. This approach aligns with modern oncology drug development practices that seek to match targeted therapies with specific molecular drivers of cancer.
The combination strategy addressing acquired resistance in NSCLC is particularly noteworthy. Resistance to EGFR and ALK inhibitors represents a substantial unmet need in lung cancer treatment. By positioning NXP900 as a potential solution to overcome this resistance, Nuvectis is targeting a critical gap in current treatment paradigms.
The company's "pipeline in a pill" characterization suggests NXP900 has multiple mechanisms of action or applications across different cancer types and genetic profiles. This is supported by their targeting of both direct (YES1) and dependent (Hippo Pathway) targets across multiple tumor types including NSCLC, mesothelioma, and renal cancer.
The successful completion of the dose escalation study and drug-drug interaction study in healthy volunteers indicates the compound has cleared important early safety hurdles, allowing progression to efficacy-focused trials. The investment by a healthcare-specialized institutional investor further validates the scientific approach and potential of this program.
- The Phase 1b program is designed to evaluate the clinical activity of NXP900 as a single agent in patients with advanced solid tumors whose cancers harbor specific genetic alterations, and in combination with EGFR and ALK inhibitors in patients with NSCLC whose cancers developed resistance to these treatments
- Nuvectis will hold a conference call tomorrow, Tuesday, August 12 at 8:30 AM ET to discuss the elements of the Phase 1b program and the overall market opportunity for NXP900
Fort Lee, NJ, Aug. 11, 2025 (GLOBE NEWSWIRE) -- (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 announced the initiation of the Phase 1b program for NXP900.
NXP900 Phase 1b clinical program
The Phase 1b program was initiated following the successful completion of a dose escalation study in patients with advanced solid tumors and a clinical drug-drug interaction study in healthy volunteer, and is intended to include a single agent component, which is now underway, and a combination component that is expected to commence later this year.
Single agent: We will evaluate patients with specific genetic alterations selected based on their characteristics as either direct (YES1 amplification), or dependent (Hippo Pathway alterations) targets of NXP900, and the tumor types were selected based on the prevalence of the relevant genetic alterations and supporting scientific data. These include:
- YES1 amplified or FAT1 mutated non-small cell lung cancer (NSCLC)
- NF2 mutated mesothelioma and renal cancer
- Other advanced solid tumors with any of the genetic alterations mentioned above or other relevant Hippo Pathway alterations
Combination: We plan to evaluate NXP900 in combination with market-leading epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors for the treatment of non-small cell lung cancer, in patients who have initially responded to treatment and subsequently developed acquired resistance and experienced disease progression.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented, "We are very excited to announce the initiation of the NXP900 Phase 1b program, starting with the single agent segment. We believe that NXP900 represents a unique 鈥榩ipeline in a pill鈥� opportunity with the potential to address several substantial areas of unmet medical need in oncology. The Phase 1b protocol was designed to showcase the potential of NXP900 as an important treatment option for various types of cancer and increase the likelihood of observing a therapeutic effect, building on an extensive scientific program to understand the underlying biology of specific cancers that may confer sensitivity to treatment with NXP900. We have high expectations for the Phase 1b program for NXP900 based on a robust dataset comprised of early mechanistic studies, preclinical proof of concept results and the emerging clinical profile from the completed Phase 1a and drug-drug interaction clinical studies,鈥� added Mr.听Bentsur. 鈥淎dditionally, we believe that the recent acquisition of shares by a highly regarded healthcare-specialized institutional investor is a vote of confidence in this Phase 1b program, and that we are well funded to execute on our ambitious plans for NXP900.鈥�
Conference Call and Webcast Information
- Date: Tuesday, August 12, 2025, at 8:30 AM ET
- Participant Dial-in (U.S.):听1-877-407-0784
- Participant Dial-in (International):听1-201-689-8560
- Webcast Access:听
A replay of the webcast will be available on the Investors section of the Nuvectis website at .
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鈥檚 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 a Phase 1a dose escalation study and the Phase 1b program has been initiated. 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:听.
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鈥�, "believe鈥�, "contemplate鈥�, "could鈥�, "estimate鈥�, "expect鈥�, "intend鈥�, "seek鈥�, "may鈥�, "might鈥�, "plan鈥�, "potential鈥�, "predict鈥�, "project鈥�, "target鈥�, "aim鈥�, "should鈥�, "will鈥�, "would鈥�, 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 the timing and data expectations for the NXP900 Phase 1b study and estimates and projections regarding our financial condition. 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
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Media Relations Contact
Kevin Gardner
LifeSci Advisors
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FAQ
What is the purpose of Nuvectis Pharma's Phase 1b program for NXP900?
Which types of cancer patients will be included in NXP900's single-agent study?
When will Nuvectis (NVCT) begin the combination therapy component of the NXP900 Phase 1b program?
What previous studies has Nuvectis completed for NXP900?
How is Nuvectis Pharma's NXP900 development program funded?
