Zentalis Azenosertib Fast Track Designation and Virtual Corporate Event

 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

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.

https://www.globenewswire.com/news-release/2025/01/09/3006950/0/en/Zentalis-Pharmaceuticals-Announces-Azenosertib-Fast-Track-Designation-and-Virtual-Corporate-Event-to-Present-Updated-Data-from-Azenosertib-Clinical-Studies.html