Nuvectis Pharma Reports Encouraging NXP800 Interim Data Supporting Ongoing Enrollment in Phase 1b Study in Patients with Platinum-Resistant ARID1a-Mutated Ovarian Cancer
Nuvectis Pharma reported encouraging interim data from its Phase 1b study of NXP800 in platinum-resistant ARID1a-mutated ovarian cancer patients. The study evaluated three dosing regimens in twelve patients, with one showing unconfirmed partial response and six achieving stable disease with tumor shrinkage. The new intermittent dosing schedule (50 mg/day, 5 days on/2 days off) successfully minimized thrombocytopenia concerns. The company is now enrolling patients for a higher dose intensity cohort at 75 mg/day on an intermittent schedule, with additional clinical data expected in Q2 2025.
Nuvectis Pharma ha riportato dati preliminari incoraggianti dal suo studio di Fase 1b su NXP800 in pazienti con cancro ovarico ARID1a-mutato resistente al platino. Lo studio ha valutato tre schemi di dosaggio in dodici pazienti, con uno che ha mostrato una risposta parziale non confermata e sei che hanno raggiunto una malattia stabile con riduzione del tumore. Il nuovo schema di dosaggio intermittente (50 mg/giorno, 5 giorni di trattamento/2 giorni di pausa) ha minimizzato con successo le preoccupazioni legate alla trombocitopenia. L'azienda sta ora arruolando pazienti per una coorte con intensità di dose più alta a 75 mg/giorno secondo uno schema intermittente, con dati clinici aggiuntivi attesi nel secondo trimestre del 2025.
Nuvectis Pharma informó datos provisionales alentadores de su estudio de Fase 1b sobre NXP800 en pacientes con cáncer de ovario mutado en ARID1a resistente al platino. El estudio evaluó tres regímenes de dosis en doce pacientes, con uno mostrando una respuesta parcial no confirmada y seis logrando enfermedad estable con reducción del tumor. El nuevo esquema de dosificación intermitente (50 mg/día, 5 días de tratamiento/2 días de descanso) minimizó con éxito las preocupaciones sobre la trombocitopenia. La compañía ahora está reclutando pacientes para una cohorte de mayor intensidad de dosis a 75 mg/día en un esquema intermitente, con datos clínicos adicionales esperados para el segundo trimestre de 2025.
누벡티스 파마는 백금 저항성 ARID1a 변형 ovarian cancer 환자에 대한 NXP800의 1b상 연구에서 고무적인 중간 데이터를 보고했습니다. 이 연구는 12명의 환자에서 세 가지 용량 요법을 평가했으며, 그 중 하나는 확인되지 않은 부분 반응을 보였고 6명은 종양 축소와 함께 안정적인 병리를 달성했습니다. 새로운 간헐적 복용 일정(50mg/일, 5일 복용/2일 휴식)은 혈소판 감소증에 대한 우려를 성공적으로 최소화했습니다. 회사는 현재 75mg/일의 간헐적 일정으로 더 높은 용량 강도 집단에 대해 환자를 모집하고 있으며, 추가 임상 데이터는 2025년 2분기에 예상됩니다.
Nuvectis Pharma a rapporté des données préliminaires encourageantes de son étude de phase 1b sur NXP800 chez des patientes atteintes de cancer de l'ovaire muté ARID1a résistant au platine. L'étude a évalué trois schémas posologiques chez douze patientes, dont l'une a montré une réponse partielle non confirmée et six ont atteint une maladie stable avec une réduction de la tumeur. Le nouveau schéma posologique intermittent (50 mg/jour, 5 jours de traitement/2 jours de pause) a réussi à minimiser les préoccupations concernant la thrombocytopénie. L'entreprise recrute maintenant des patientes pour une cohorte à plus forte intensité de dose à 75 mg/jour selon un schéma intermittent, avec des données cliniques supplémentaires attendues au deuxième trimestre 2025.
Nuvectis Pharma berichtete über ermutigende Zwischen Ergebnisse aus seiner Phase 1b-Studie zu NXP800 bei platinsensitiven ARID1a-mutativen Eierstockkrebspatientinnen. Die Studie bewertete drei Dosierungsschemata an zwölf Patienten, von denen eines eine nicht bestätigte partielle Reaktion zeigte und sechs eine stabile Erkrankung mit Tumorverkleinerung erreichten. Das neue intermittierende Dosierungsschema (50 mg/Tag, 5 Tage Behandlung/2 Tage Pause) hat die Bedenken hinsichtlich Thrombozytopenie erfolgreich minimiert. Das Unternehmen rekrutiert nun Patienten für eine Kohorte mit höherer Dosierungsintensität von 75 mg/Tag nach einem intermittierenden Schema, wobei zusätzliche klinische Daten im 2. Quartal 2025 erwartet werden.
- Demonstrated single agent antitumor activity with 1 partial response and 6 stable disease cases
- New intermittent dosing schedule successfully reduced thrombocytopenia from Grade 4 to maximum Grade 2
- FDA granted Fast Track Designation and Orphan Drug Designation for the treatment
- Study advancing to higher dose intensity cohort to potentially enhance efficacy
- Initial dosing regimen caused Grade 4 thrombocytopenia in 3 of 4 patients
- Common adverse events including nausea, fatigue, vomiting, diarrhea and constipation reported
- Need to increase dose intensity identified, suggesting current efficacy levels may be suboptimal
Insights
The interim Phase 1b data for NXP800 shows meaningful clinical activity in a difficult-to-treat patient population with platinum-resistant ARID1a-mutated ovarian cancer. Key findings include:
- 1 unconfirmed partial response and 6 stable disease cases with tumor shrinkage out of 11 evaluable patients
- Successfully addressed Grade 4 thrombocytopenia through intermittent dosing (5 days on/2 days off)
- Manageable safety profile with mostly Grade 1-2 side effects
This interim data represents a significant milestone for NVCT's lead program. With a market cap of only
- NXP800 demonstrated single agent activity
- New dosing schedule successfully minimized thrombocytopenia
Fort Lee, NJ, Nov. 14, 2024 (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 reported encouraging data from the Phase 1b study evaluating NXP800 in patients with platinum resistant ARID1a-mutated ovarian cancer. Platinum-resistant, ARID1a-mutated ovarian cancer is a serious condition that carries a poor prognosis with an estimated life expectancy of approximately one year from diagnosis.
The NXP800 development program in this disease was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”), and NXP800 was granted Orphan Drug Designation by the FDA for the treatment of ARID1a deficient ovarian, fallopian tube and primary peritoneal cancers.
Phase 1B Update
Three dosing regimens have been evaluated to date in twelve patients (four patients were treated on a once per day dosing schedule, two with 75 mg/day and two with 50 mg/day. Subsequently, eight additional patients were treated with 50 mg/day on an intermittent dosing schedule of five days on / two days off, a dosing schedule implemented to mitigate thrombocytopenia). All patients enrolled into the study failed at least two prior lines of systemic chemotherapy, including at least one prior platinum-based chemotherapy regimen, and most had also failed treatment with bevacizumab.
In eleven efficacy-evaluable patients, antitumor activity was observed with best responses including one patient with an unconfirmed partial response and six patients with stable disease, including tumor shrinkage.
The Phase 1b interim data reported earlier this year included four patients evaluable for safety, of which three experienced Grade 4 thrombocytopenia. Subsequently, in the eight patients treated with NXP800 using the intermittent dosing schedule (50 mg/day, 5 days on / 2 days off), the highest grade of thrombocytopenia observed was Grade 2 (one patient). Other than thrombocytopenia, the most common treatment emergent adverse events included nausea, fatigue, vomiting, diarrhea and constipation, the majority of which being Grade 1-2.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented: “We continue to be encouraged by the early results from our Phase 1b study with NXP800. The antitumor activity observed despite patients’ advanced disease and extensive pre-treatment, while controlling for thrombocytopenia, is promising. However, it is clear that we need to increase the dose intensity to drive more efficacy in the next set of patients. We are already enrolling patients into a cohort of up to 10-12 additional patients utilizing a regimen of 75 mg/day on an intermittent dosing schedule, which is expected to be the last cohort in this Phase 1b study. We believe that NXP800 is an active agent and that this higher dose intensity should provide for increased exposure that could enable us to reach our goal of demonstrating enhanced activity with acceptable overall tolerability. We expect to provide additional clinical data from the Phase 1b study in the second quarter of 2025.”
Mr. Bentsur concluded, “With the Phase 1b study advancing as described, we also expect to regain momentum in the ongoing Investigator-Initiated Study in cholangiocarcinoma, being conducted in collaboration with the Mayo Clinic. We believe that together with NXP900’s continued advancement and significant development options of blockbuster potential, our pipeline positions us to deliver on our mission of developing novel treatments for serious conditions of unmet medical needs in oncology.”
About the Phase 1b Study
The Phase 1b study is a multicenter, single arm, open-label clinical trial of NXP800 in patients with platinum-resistant, ARID1a-mutated ovarian cancer. The study is designed to examine the safety and preliminary efficacy of NXP800 in this target patient population.
The study is being conducted in the US and UK in collaboration with the GOG Foundation, Inc. and the European Network of Gynecological Oncological Trial Groups, recognized as the world's leading gynecology oncology clinical trials consortia.
About NXP800
NXP800 is an oral, small molecule, potentially first-in-class GCN2 kinase activator. The NXP800 development program in platinum-resistant, ARID1a-mutated ovarian cancer was granted Fast Track Designation by the FDA, and Orphan Drug Designation for the treatment of ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers. NXP800 is also being evaluated in an investigator-initiated study conducted in collaboration with the Mayo Clinic for the treatment of cholangiocarcinoma. The FDA has also granted NXP800 Orphan Drug Designation in this indication.
Nuvectis licensed exclusive world-wide rights to NXP800 from the Institute of Cancer Research in London, UK.
About Platinum-Resistant, ARID1a-Mutated Ovarian Carcinoma
ARID1a-mutated ovarian carcinoma is comprised almost exclusively of two histologies, ovarian clear cell carcinoma (“OCCC”) and ovarian endometrioid carcinoma (“OEC”), each representing about
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 is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900 has a unique mechanism of action in that it inhibits both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the 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, including safety and efficacy data generated to date for NXP800 and NXP900, 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 and data regarding the preclinical studies for NXP800 and NXP900, and the Phase 1a data for NXP800 and the NXP900 Phase 1a study to date, as well as the clinical expectations for the ongoing NXP800 Phase 1b study in platinum-resistant, ARID1a-mutated ovarian carcinoma, including the potential ability of a higher dose intensity going forward in the NXP800 Phase 1b study to generate satisfactory safety and efficacy results, statements regarding NXP800's potential ability to become a therapeutic option for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma, cholangiocarcinoma, and potentially other cancer indications, and the timing for completion of the clinical trials, including the ongoing NXP800 investigator-initiated study in cholangiocarcinoma and statements regarding NXP900's therapeutic potential. 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 3Q 2024 Form 10-Q and our other public filings with the 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
201-614-3151
rbentsur@nuvectis.com
Media Relations Contact
Christopher M. Calabrese
LifeSci Advisors
Tel: 917-680-5608
ccalabrese@lifesciadvisors.com
FAQ
What are the interim results of NXP800 Phase 1b trial for NVCT?
What is the new dosing schedule for NXP800 (NVCT) and why was it implemented?
When will Nuvectis (NVCT) release additional Phase 1b data for NXP800?
What regulatory designations has NXP800 (NVCT) received?
