Nuvectis Pharma Announces Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
Nuvectis Pharma (NASDAQ: NVCT) has announced that its drug NXP800 has received Orphan Drug Designation from the FDA for treating ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. This designation is significant as ovarian cancer typically exceeds the 200,000 patient threshold for Orphan Drug eligibility. The company views this as validation for NXP800's mechanism of action and target patient population in their ongoing Phase 1b clinical trial for platinum-resistant, ARID1a-mutated ovarian cancer. Nuvectis plans to provide a data update from this study in fall 2024.
Nuvectis Pharma (NASDAQ: NVCT) ha annunciato che il suo farmaco NXP800 ha ricevuto la Designazione di Farmaco Orfano dalla FDA per il trattamento dei cancro ovarico, delle tube di Falloppio e peritoneale primario con deficienza di ARID1a. Questa designazione è significativa poiché il cancro ovarico supera tipicamente la soglia di 200.000 pazienti per l'idoneità al Farmaco Orfano. L'azienda considera ciò una validazione per il meccanismo d'azione di NXP800 e per la popolazione di pazienti target nel loro attuale trial clinico di fase 1b per il cancro ovarico resistente al platino e con mutazione di ARID1a. Nuvectis prevede di fornire un aggiornamento sui dati di questo studio nell'autunno del 2024.
Nuvectis Pharma (NASDAQ: NVCT) ha anunciado que su medicamento NXP800 ha recibido la Designación de Medicamento Huérfano de la FDA para tratar cánceres de ovario, trompa de Falopio y peritoneo primario deficientes en ARID1a. Esta designación es significativa ya que el cáncer de ovario típicamente supera el umbral de 200,000 pacientes para la elegibilidad de Medicamento Huérfano. La empresa considera esto como una validación del mecanismo de acción de NXP800 y la población de pacientes objetivo en su actual ensayo clínico de fase 1b para el cáncer de ovario resistente al platino y mutado en ARID1a. Nuvectis planea proporcionar una actualización de datos de este estudio en otoño de 2024.
Nuvectis Pharma (NASDAQ: NVCT)는 자사의 약물 NXP800이 ARID1a 결핍에 의한 난소, 나팔관 및 1차 복막암 치료를 위한 FDA의 고아약 지정을 받았다고 발표했습니다. 이 지정은 난소암이 일반적으로 200,000명의 환자 기준을 초과하기 때문에 중요합니다. 회사는 이를 NXP800의 작용 메커니즘과 현재 1b상 임상 시험에서의 표적 환자 집단에 대한 검증으로 보고 있습니다. Nuvectis는 2024년 가을에 이 연구의 데이터 업데이트를 제공할 계획입니다.
Nuvectis Pharma (NASDAQ: NVCT) a annoncé que son médicament NXP800 a reçu la Désignation de Médicament Orphelin de la FDA pour le traitement des cancers de l'ovaire, de la trompe de Fallope et péritonéaux primaires déficients en ARID1a. Cette désignation est significative, car le cancer de l'ovaire dépasse généralement le seuil de 200 000 patients pour l'éligibilité au Médicament Orphelin. La société considère cela comme une validation pour le mécanisme d'action de NXP800 et la population de patients cible dans leur essai clinique de phase 1b en cours pour le cancer de l'ovaire résistant au platine et mutant de l'ARID1a. Nuvectis prévoit de fournir une mise à jour des données de cette étude à l'automne 2024.
Nuvectis Pharma (NASDAQ: NVCT) hat angekündigt, dass sein Medikament NXP800 von der FDA die Orphan Drug Designation für die Behandlung von ARID1a-defizienten Eierstock-, Eileiter- und primären Peritonealkrebsarten erhalten hat. Diese Auszeichnung ist signifikant, da Eierstockkrebs typischerweise die Schwelle von 200.000 Patienten für die Orphan-Drug-Berechtigung überschreitet. Das Unternehmen sieht dies als Validierung für den Wirkmechanismus von NXP800 und die Zielpatientenpopulation in ihrer laufenden Phase 1b klinischen Studie für platinum-resistenten, ARID1a-mutierten Eierstockkrebs. Nuvectis plant, im Herbst 2024 ein Update zu den Daten aus dieser Studie bereitzustellen.
- NXP800 granted Orphan Drug Designation by FDA for ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers
- Orphan Drug Designation provides validation for NXP800's mechanism of action and target patient population
- Ongoing Phase 1b clinical trial for platinum-resistant, ARID1a-mutated ovarian cancer
- Data update from the clinical trial expected in fall 2024
- None.
The FDA's Orphan Drug Designation for NXP800 in ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers is a significant milestone for Nuvectis Pharma. This designation, typically reserved for rare diseases, highlights the unmet medical need in this specific subset of ovarian cancer patients.
The focus on ARID1a-deficient cancers demonstrates a precision medicine approach, targeting a specific genetic alteration. This strategy could potentially lead to more effective treatments with fewer side effects compared to broad-spectrum therapies. The ongoing Phase 1b trial in platinum-resistant, ARID1a-mutated ovarian cancer patients will be important in validating this approach.
Investors should watch for the upcoming data update this fall, as positive results could significantly impact Nuvectis's market position in the competitive oncology field.
The Orphan Drug Designation for NXP800 provides Nuvectis with several financial and regulatory advantages. These typically include:
- Seven years of market exclusivity upon FDA approval
- Tax credits for clinical trial expenses
- Waiver of FDA user fees
- Potential for expedited regulatory review
These benefits can significantly reduce development costs and time-to-market, potentially improving Nuvectis's return on investment for NXP800. The designation also serves as a de-risking factor for investors, as it indicates FDA recognition of the drug's potential in addressing an unmet medical need.
However, it's important to note that this is an early-stage development and significant clinical and regulatory hurdles remain before potential commercialization.
FORT LEE, N.J., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) (“Nuvectis” or the “Company”), 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 that NXP800 was granted Orphan Drug Designation by the United States Food and Drug Administration (“FDA”) for the treatment of AT-rich interactive domain-containing protein 1a (ARID1a) ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We are very pleased to have received this designation from the FDA for NXP800. The prevalence of ovarian cancer, which is comprised of ovarian, fallopian tube and primary peritoneal cancers, exceeds the 200,000 patient threshold below which drugs may be eligible to receive Orphan Drug Designation in the United States and in ovarian cancer it has been uncommon to receive this designation for the treatment of a subset of the disease. We therefore believe that this Orphan Drug Designation granted by the FDA for NXP800 for the treatment of a subset of ovarian cancer, specifically for patients with an ARID1a deficiency, provides further validation for NXP800's mechanism of action and the target patient population in our ongoing Phase 1b clinical trial in patients with platinum resistant, ARID1a-mutated ovarian cancer. We expect to provide a data update from this study this coming fall.”
About Orphan Drug Designation
Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Orphan Drug Designation provides certain financial incentives to support clinical development, and the potential for up to seven years of marketing exclusivity for the product for the designated orphan indication in the United States if the product is approved for its designated indication.
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. The U.S. Food and Drug Administration granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma and ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. 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
Certain statements in this presentation constitute “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, 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 regarding the potential benefits of the Orphan Drug Designation granted to NXP800, the preclinical and the Phase 1a data generated to date for NXP800 and the clinical expectations for the NXP800 Phase 1b study, including statements regarding NXP800's mechanism of action and its 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 this study. 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 2Q 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 is the Orphan Drug Designation granted to Nuvectis Pharma's NXP800?
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