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FDA has placed a partial clinical hold on ZN-c3-001, DENALI and TETON monotherapy studies of azenosertib
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Monotherapy data to be presented in the second half of 2024
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Conference call to be held today, June 18, 8:00 am ET
SAN DIEGO, June 18, 2024 (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 U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the following studies of azenosertib: the Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the Phase 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer (PROC) and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC). This action follows two recent deaths due to presumed sepsis in the DENALI study.
“Patient safety is our top priority and any deaths that occur in the setting of clinical trials are unfortunate. We are working closely with the FDA to resolve this partial clinical hold as quickly as possible,” said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. “Over 500 patients have been treated with azenosertib monotherapy to date, and we believe that our data indicate a favorable therapeutic index that could potentially offer meaningful benefits to women facing PROC and USC. We have completed enrollment for Cohort 1b of the DENALI study, where we’ve enrolled more than a hundred patients, further demonstrating the support we’ve seen for having a novel oral therapy like azenosertib. We look forward to sharing these results along with overall efficacy and safety data from DENALI Cohort 1b later this year.”
In addition to sharing topline results of Cohort 1b of DENALI, the Company remains on track to present results from the ZN-c3-001 and Phase 1/2 ZN-c3-006 (MAMMOTH) studies later this year. The Company will provide additional updates to the azenosertib clinical development and other data timelines following resolution of the partial clinical hold. Zentalis remains committed to the azenosertib development program and bringing this potentially practice-changing therapy to patients with gynecological malignancies.
Conference Call Details
Zentalis will host a live conference call and webcast today at 8:00 a.m. Eastern Time to provide a business update. To access the live conference call by telephone, please register at: https://register.vevent.com/register/BI24249bb9e5714044b9f4057f28565923. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: https://edge.media-server.com/mmc/p/y2wz6vv6. The webcast will also be made available on the Company's website at www.zentalis.com under the Investors & Media section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.
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 and hematologic malignancies. 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, homologous recombination deficient 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.
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