Adavosertib

Investor call to be held on Friday, November 10th, at 10:00 a.m. ET Company also to participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 15th, 2023 at 8:30 a.m. GMT NEW YORK and SAN DIEGO, Nov. 09, 2023 (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 Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis, and Melissa Epperly, MBA, Chief Financial Officer of Zentalis, will be joined by gynecologic oncology key opinion leader, Joyce F. Liu, M.D., MPH, for an investor call on Friday, November 10th, at 10:00 a.m. ET hosted by TD Cowen to discuss the azenosertib ovarian cancer clinical updates that were announced earlier this week. Dr. Blackwell will also participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 15th, 2023 at 8:30 a.m. GMT. Access to live webcasts of both events, as well as archived recordings, will be available under the “Events & Presentations” tab on the Investors & Media section of the Company’s website at www.zentalis.com. About Joyce F. Liu, M.D., MPHDr. Liu received her medical degree from Harvard Medical School in 2002. She completed her residency in Internal Medicine at Brigham and Women's Hospital, and her fellowship in Hematology Oncology at the Dana-Farber Cancer Institute. In 2008, she joined the staff of Dana-Farber and Brigham and Women's Hospital, where she is a medical oncologist and clinical investigator in the Division of Gynecologic Oncology. Her research focuses on identifying and validating potential therapeutic targets in advanced platinum-resistant ovarian cancer, in an in-vitro setting as well as in a murine xenograft model of ovarian cancer. Dr. Liu is also active in conducting clinical research directed towards developing a better understanding of the basic biology of ovarian cancer and translating discoveries from the laboratory into the clinical setting. Dr. Liu was the presenting author on Zentalis’ GOG-3072/ZN-c3-002 study of azenosertib in combination with chemotherapy in platinum-resistant/refractory ovarian cancer (ASCO Annual Meeting 2023) and was also the presenting author on the ADAGIO study of adavosertib, a legacy Wee1 inhibitor, in uterine serous carcinoma (SGO Annual Meeting on Women’s Cancer 2023). 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 and homologous recombination deficient tumors. 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 both New York and 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. Contact:Katie Beach Oltsik Evoke CanaleKatherine.Beach@evokegroup.com

New data are enough for Zentalis Pharmaceuticals to begin preparations for a phase 3 study comparing azenosertib dosed intermittently in combination with either carboplatin or paclitaxel. A year after getting Pfizer’s backing, Zentalis Pharmaceuticals says new data for a WEE1 candidate justifies putting the asset into a phase 3 study for ovarian cancer next year. The phase 1b trial enrolled 115 patients with platinum-resistant ovarian cancer, of which 94 were evaluable by the April 10 cutoff. The findings—published in an abstract ahead of this year’s American Society of Clinical Oncology annual meeting—showed that the synthetic lethal WEE1 inhibitor azenosertib plus the chemotherapy paclitaxel produced an overall response rate (ORR) of 50%. When given in a regimen with other chemotherapies like gemcitabine or carboplatin, the WEE1 candidate demonstrated an ORR of 38.5% and 35.7%, respectively. A regimen with pegylated liposomal doxorubicin posted the lowest ORR at 19.4%. As for median progression-free survival (mPFS), azenosertib plus carboplatin came out on top at 10.4 months, followed by azenosertib plus gemcitabine at 8.3 months. The regimens that included paclitaxel and pegylated liposomal doxorubicin only saw mPFS of 7.4 months and 6.3 months, respectively. Zentalis was also able to test for expression of the Cyclin E1 protein in 82 of the patients and the biotech noted that Cyclin E1+ status was associated with a superior ORR and a longer mPFS. This finding “showcase[es] the potential synergy of WEE1 inhibition with chemotherapy in this patient population,” the biotech concluded. The most common treatment-related adverse events of grade 3 or above across all cohorts were thrombocytopenia (27.5%), neutropenia (25.5%), anemia (15.7%) and fatigue (9.8%). The data are enough for Zentalis to begin preparations for a phase 3 study comparing azenosertib dosed intermittently in combination with either carboplatin or paclitaxel in patients with Cyclin E1+status and with platinum-sensitive ovarian cancer. The biotech expects to launch the late-stage trial in the first quarter of 2024. “Azenosertib is emerging as a very promising clinical candidate, with demonstrated anti-tumor activity in difficult-to-treat tumor types when used in combination with standard chemotherapy regimens,” Zentalis CEO Kimberly Blackwell, M.D., said in the release. “The addition of azenosertib increased ORRs and mPFS over those observed historically with chemotherapy alone, or compared to adavosertib in combination with chemotherapy.” Despite Pfizer throwing its weight behind Zentalis with a $25 million investment in April 2022, the biotech was able to retain full economic ownership of azenosertib, then known as ZN-c3. At the time, Zentalis said it planned to use the Big Pharma’s cash to support clinical trials of azenosertib and ZN-d5, an oral inhibitor of BCL-2 in development in blood cancers including acute myeloid leukemia and non-Hodgkin lymphoma. WEE1 enzymes play a role in the DNA damage response, or DDR, pathway. The idea behind WEE1 inhibitors is that they could boost the efficacy of DNA-damaging therapies by forcing tumors to replicate damaged DNA before it is fixed.