Zentalis Shares Drop 30% After FDA Puts Partial Hold on WEE1 Drug
June 18th, 2024 // 1:07 pm @ jmpickett
FDA has put three trials of the WEE1 candidate by Zentalis on a partial hold after two deaths that are alleged to have been caused by sepsis. The deaths happened during the Phase 2 DENALI clinical study. The purpose of the study was to evaluate the synthetic lethal WEE1 inhibitor azenosertib in people with ovarian cancer resistant to platinum.
The FDA hold extends to other clinical studies of azenosertib for use in monotherapy, which is a Phase 2 trial for uterine serous carcinoma, as well as a Phase 1 dose escalation study in solid cancer tumors.
The Zentalis CEO, Kimberly Blackwell, MD, said that patient safety is the company’s top priority and any deaths that occur during trials are tragic. She added that the company is working closely with FDA to resolve the partial clinical hold quickly.
About 500 patients have received treatments with azenosertib for monotherapy across many clinical trials to date. The DENALI trial by itself enrolled more than 100 patients in one cohort.
The firm is still on track to report its topline clinical trial results from its Phase 1 solid tumor trial. It also is on pace to release results of a Phase 1 and 2 trial for azenosertib combined with GSK’s Zejula for ovarian cancer in late 2024.
