Zentalis Pharmaceuticals Updates on Azenosertib Clinical Program

SAN DIEGO, June 18, 2024 -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has issued a partial clinical hold on several studies involving their investigational drug azenosertib. The affected studies include the Phase 1 ZN-c3-001 dose-escalation trial 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 decision follows two recent deaths attributed to suspected sepsis in the DENALI study.

"Ensuring patient safety is our utmost priority, and any fatality in clinical trials is deeply regrettable," stated Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "We are in active collaboration with the FDA to address and resolve this partial clinical hold as swiftly as possible. To date, over 500 patients have undergone treatment with azenosertib monotherapy, and our data suggest a promising therapeutic index that could provide significant benefits for women battling PROC and USC. The completion of enrollment for Cohort 1b of the DENALI study, which included over a hundred patients, underscores the support for innovative oral therapies like azenosertib. We anticipate sharing results from this cohort, along with comprehensive efficacy and safety data, later this year."

Aside from the DENALI study, Zentalis is also planning to present findings from the ZN-c3-001 and Phase 1/2 ZN-c3-006 (MAMMOTH) studies later this year. The company remains dedicated to its azenosertib clinical development program and the potential impact it could have on patients with gynecological cancers. Further updates on the azenosertib clinical development timeline and additional data will be provided following the resolution of the partial clinical hold.

Zentalis Pharmaceuticals continues to focus on developing azenosertib, their lead product candidate, which is a potentially first-in-class and best-in-class WEE1 inhibitor designed for advanced solid tumors and hematologic malignancies. Azenosertib has shown tolerability and anti-tumor activity in various clinical trials, both as a monotherapy and in combination with other chemotherapy treatments. The company is also exploring enrichment strategies targeting tumors with high genomic instability, such as Cyclin E1 positive tumors, homologous recombination deficient tumors, and tumors with oncogenic driver mutations.

Zentalis leverages its expertise in cancer biology and medicinal chemistry to further its research, particularly in the area of protein degraders. The company operates out of San Diego and is committed to advancing its clinical-stage programs to provide new therapeutic options for cancer patients.

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