Zentalis Pharmaceuticals Announces Azenosertib Fast Track Designation and Virtual Corporate Event to Present Updated Data from Azenosertib Clinical Studies
Zentalis Pharmaceuticals (ZNTL) announced that the FDA has granted Fast Track Designation to azenosertib for treating Cyclin E1-positive patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC). This designation aims to expedite the development and review process for medicines addressing serious unmet medical needs.
The company published research in npj Precision Oncology demonstrating that high levels of Cyclin E1/CDK2 activation predict sensitivity to azenosertib. Zentalis will host a corporate webcast on January 29, 2025, to present comprehensive clinical data, including topline results from 102 patients in the Phase 2 DENALI study, final results from Phase 1b trial with 69 PROC patients, and data from 61 patients in the MAMMOTH trial. The event will also cover registration-intent study designs and regulatory updates.
Zentalis Pharmaceuticals (ZNTL) ha annunciato che la FDA ha concesso la Designazione Fast Track ad azenosertib per il trattamento di pazienti positivi al Cyclin E1 con cancro ovarico epiteliale, tubarico o peritoneale primario (PROC) resistenti al platino. Questa designazione mira a velocizzare il processo di sviluppo e revisione dei farmaci che affrontano gravi esigenze mediche non soddisfatte.
L'azienda ha pubblicato ricerche in npj Precision Oncology dimostrando che alti livelli di attivazione di Cyclin E1/CDK2 prevedono la sensibilità ad azenosertib. Zentalis ospiterà un webcast aziendale il 29 gennaio 2025 per presentare dati clinici completi, compresi i risultati preliminari da 102 pazienti dello studio di fase 2 DENALI, i risultati finali dello studio di fase 1b con 69 pazienti PROC e i dati da 61 pazienti nello studio MAMMOTH. L'evento tratterà anche i disegni degli studi di intenzione di registrazione e gli aggiornamenti normativi.
Zentalis Pharmaceuticals (ZNTL) anunció que la FDA ha otorgado la designación de vía rápida a azenosertib para el tratamiento de pacientes positivos para Cyclin E1 con cáncer epitelial de ovario, trompa de Falopio o cáncer peritoneal primario (PROC) que son resistentes al platino. Esta designación tiene como objetivo agilizar el desarrollo y el proceso de revisión de medicamentos que abordan necesidades médicas graves no satisfechas.
La compañía publicó investigaciones en npj Precision Oncology que demuestran que altos niveles de activación de Cyclin E1/CDK2 predicen sensibilidad a azenosertib. Zentalis llevará a cabo un webcast corporativo el 29 de enero de 2025 para presentar datos clínicos completos, incluidos los resultados generales de 102 pacientes en el estudio de fase 2 DENALI, resultados finales del ensayo de fase 1b con 69 pacientes PROC y datos de 61 pacientes en el ensayo MAMMOTH. El evento también abordará los diseños de estudios de intención de registro y actualizaciones regulatorias.
Zentalis Pharmaceuticals (ZNTL)는 FDA가 플래티넘 저항성 상피 난소, 나팔관 또는 원발성 복막암(PROC)을 가진 Cyclin E1 양성 환자 치료를 위한 azenosertib에 신속 심사 지정을 부여했다고 발표했습니다. 이 지침은 심각한 의료 미충족 수요를 해결하는 약물 개발 및 검토 프로세스를 가속화하는 것을 목표로 합니다.
회사는 npj Precision Oncology에 사이클린 E1/CDK2 활성화가 azenosertib에 대한 민감성을 예측한다는 연구 결과를 발표했습니다. Zentalis는 2025년 1월 29일에 종합 임상 데이터를 발표하기 위한 기업 웹캐스트를 개최할 예정이며, 여기에는 102명의 환자에 대한 2상 DENALI 연구의 주요 결과, 69명의 PROC 환자에 대한 1b상 시험의 최종 결과 및 MAMMOTH 시험의 61명 환자로부터의 데이터가 포함됩니다. 이 이벤트에서는 등록 의도 연구 설계 및 규제 업데이트에 대해서도 다룰 예정입니다.
Zentalis Pharmaceuticals (ZNTL) a annoncé que la FDA a accordé la désignation Fast Track à azenosertib pour le traitement des patients positifs pour Cyclin E1 atteints de cancer épithélial de l’ovaire, des trompes de Fallope ou de cancer péritonéal primaire (PROC) résistant au platine. Cette désignation vise à accélérer le développement et le processus d'examen des médicaments répondant à des besoins médicaux graves non satisfaits.
L'entreprise a publié des recherches dans npj Precision Oncology démontrant que des niveaux élevés d'activation de Cyclin E1/CDK2 prédisent la sensibilité à azenosertib. Zentalis organisera un webinaire d'entreprise le 29 janvier 2025 pour présenter des données cliniques complètes, y compris les résultats globaux de 102 patients de l'étude de phase 2 DENALI, les résultats finaux de l'essai de phase 1b avec 69 patients PROC et les données de 61 patients de l'essai MAMMOTH. L'événement abordera également les conceptions d'études d'intention d'enregistrement et les mises à jour réglementaires.
Zentalis Pharmaceuticals (ZNTL) gab bekannt, dass die FDA azenosertib die Schnellbearbeitungs-Designierung zur Behandlung von Cyclin E1-positiven Patienten mit platinschem-resistentem epithelialen Ovarial-, Eileiter- oder primären Bauchfellkrebs (PROC) gewährt hat. Diese Designierung soll den Entwicklungs- und Überprüfungsprozess für Medikamente beschleunigen, die schwerwiegende unerfüllte medizinische Bedürfnisse adressieren.
Das Unternehmen veröffentlichte Forschungsergebnisse in npj Precision Oncology, die zeigen, dass hohe Aktivierungswerte von Cyclin E1/CDK2 die Empfindlichkeit gegenüber azenosertib vorhersagen. Zentalis wird am 29. Januar 2025 ein Unternehmens-Webcast veranstalten, um umfassende klinische Daten zu präsentieren, einschließlich der vorläufigen Ergebnisse von 102 Patienten aus der Phase-2-Studie DENALI, den endgültigen Ergebnissen der Phase-1b-Studie mit 69 PROC-Patienten und den Daten von 61 Patienten aus der MAMMOTH-Studie. Bei der Veranstaltung werden auch Registrierungsabsichten und aktuelle regulatorische Updates behandelt.
- FDA Fast Track Designation received for azenosertib, potentially accelerating regulatory review
- Research publication in npj Precision Oncology validates biomarker-directed strategy
- Extensive clinical data presentation upcoming for multiple trials with large patient cohorts
- None.
Insights
The FDA's Fast Track Designation for azenosertib represents a important regulatory milestone for Zentalis. This designation for Cyclin E1-positive ovarian cancer patients could potentially accelerate the drug's path to market, particularly significant given the $199M market cap company's focus on this underserved patient population.
The publication in npj Precision Oncology strengthens the scientific foundation for azenosertib's biomarker-driven approach. The upcoming presentation of data from three clinical trials - DENALI (102 patients), ZN-c3-001 (69 PROC patients) and MAMMOTH (61 patients) - will be important for validating the drug's efficacy profile. The partnerships with industry giants GSK and Pfizer add credibility to the program.
The biomarker-driven strategy targeting Cyclin E1/CDK2 activation is particularly noteworthy. Cyclin E1 overexpression is associated with chemotherapy resistance and poor prognosis in ovarian cancer, making this a strategically important therapeutic approach. The comprehensive clinical data package spanning multiple trials suggests a thorough evaluation of azenosertib's potential.
Think of Cyclin E1 as a molecular fingerprint that helps identify which patients are most likely to respond to treatment - similar to how HER2 testing guides breast cancer treatment decisions. The upcoming data presentation could validate this precision medicine approach in an area where treatment options are
From a market perspective, this development positions Zentalis strategically in the precision oncology space. The Fast Track Designation typically reduces time to market by several months and can enhance investor confidence. The collaboration with GSK and Pfizer not only provides validation but also potential commercialization advantages.
The extensive clinical trial program with over 230 patients across different studies demonstrates a robust development strategy. For a small-cap biotech, this level of comprehensive data collection and strategic partnerships suggests strong commercial potential, particularly if the upcoming data supports the biomarker-driven approach.
Azenosertib Fast Track Designation granted for Cyclin E1 positive patients by U.S. Food and Drug Administration (FDA)
Manuscript focused on role of Cyclin E1/CDK2 activation predicting sensitivity to azenosertib published in npj Precision Oncology
Corporate event to be held on January 29, 2025 to provide updates on azenosertib clinical data, development and regulatory path
SAN DIEGO, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the FDA has granted Fast Track Designation to azenosertib for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC) who are positive via Cyclin E1 immunohistochemistry for protein levels. The FDA grants investigational medicines Fast Track Designation to facilitate the development and expedite the review of medicines that demonstrate the potential to treat serious conditions and fill an unmet medical need.
"Zentalis is sharply focused on our goal of bringing azenosertib to patients with gynecological malignancies,” said Ingmar Bruns, Chief Medical Officer. “The FDA’s decision to grant Fast Track Designation for azenosertib in Cyclin E1 positive ovarian cancer patients underscores the unmet medical need in this patient population which has historically been associated with resistance to chemotherapy and poor patient outcomes. This designation provides meaningful benefits, including those that may expedite the regulatory review of this product candidate in this patient population. We look forward to sharing updated azenosertib clinical data and a regulatory update, including plans for registration-intent studies, at our corporate event on January 29.”
In addition, this week npj Precision Oncology published a paper from Zentalis researchers highlighting the role of Cyclin E1/CDK2 activation in predicting sensitivity to azenosertib.
“The data in this manuscript provide functional and mechanistic demonstration that preclinical models with high levels of Cyclin E1 activation are particularly sensitive to azenosertib inhibition, along with supporting clinical data from select patients enrolled in azenosertib clinical studies,” said Mark Lackner, Chief Scientific Officer. “We believe these data support a biomarker-directed strategy to identify patients most likely to benefit from azenosertib.”
Corporate Event
On January 29, 2025, at 8:00am ET Zentalis will host a webcast to present data from its studies of azenosertib in PROC and provide a regulatory and development update, including the following:
- Topline results from 102 patients enrolled in Part 1b of the Phase 2 DENALI study (ZN-c3-005) of azenosertib monotherapy in platinum resistant high-grade serous ovarian cancer
- Final results from patients treated at therapeutic doses in the Phase 1b ZN-c3-001 azenosertib monotherapy trial in solid tumors, including 69 PROC patients
- Topline data from 61 patients in the monotherapy arm of the Phase 1/2 MAMMOTH (ZN-c3-006) trial of azenosertib as a monotherapy and in combination with PARP inhibitor (niraparib) in PARP-resistant PROC in partnership with GSK
- Presentation of design of registration-intent study and a regulatory update
- Initial data from the Phase 1 ZN-c3-016 azenosertib + BEACON regimen (encorafenib + cetuximab) trial in BRAF mutant metastatic colorectal cancer in partnership with Pfizer
Additional information on the corporate webcast, including registration links and dial in information, will be posted to the Investors & Media section of www.zentalis.com.
About Azenosertib
Azenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and in combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent cycling of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression in the presence of high levels of DNA damage, thereby resulting in the further accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
About Zentalis Pharmaceuticals
Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers. The Company’s lead product candidate, azenosertib (ZN-c3), is a potentially first-in-class and best-in-class WEE1 inhibitor for advanced solid tumors. Azenosertib is being evaluated as a monotherapy and in combination across multiple clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types and in combination with several chemotherapy backbones. As part of its azenosertib clinical development program, the Company is exploring enrichment strategies targeting tumors of high genomic instability, such as Cyclin E1 positive tumors and tumors with oncogenic driver mutations. The Company is also leveraging its extensive experience and capabilities across cancer biology and medicinal chemistry to advance its research on protein degraders. Zentalis has operations in San Diego.
For more information, please visit www.zentalis.com. Follow Zentalis on X/Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the potential of azenosertib; our plans to hold a corporate event and provide updates on clinical data, development and regulatory path, including the timing and content thereof; the potential of azenosertib to treat serious conditions and fill an unmet medical need; the potential for Fast Track Designation to provide meaningful benefits, including those that may expedite the regulatory review of azenosertib in the applicable patient population; our belief that data support a biomarker-directed strategy to identify patients most likely to benefit from azenosertib; the potential for azenosertib to be first-in-class and best-in-class; the broad franchise potential of azenosertib; and our plans with respect to the development of our product candidates, including azenosertib. The terms “believe,” “goal,” “likely,” “look forward,” “may,” “plan,” “potential,” “support,” “to be,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our plans, including the costs thereof, of development of any diagnostic tools; our substantial dependence on the success of our lead product candidate, azenosertib; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; failure to identify additional product candidates and develop or commercialize marketable products; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; failure to obtain U.S. or international marketing approval; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
Contact:
Elizabeth Pingpank Hickin
ehickin@zentalis.com
860-463-0469
FAQ
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