On April 26, 2023 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported that it will present positive clinical data from its Phase 1b trial investigating azenosertib in combination with chemotherapy in patients with advanced platinum-resistant ovarian cancer in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting in Chicago, June 2-6, 2023 (Press release, Zentalis Pharmaceuticals, APR 26, 2023, View Source [SID1234630548]). Azenosertib is the Company’s potentially first-in-class Wee1 inhibitor currently being investigated in multiple clinical trials as a monotherapy and in combination.
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The poster, entitled "Correlation of Cyclin E1 expression and clinical outcomes in a Phase 1b dose- escalation study of Azenosertib (ZN-c3), a Wee1 inhibitor, in combination with chemotherapy in patients with platinum-resistant or refractory (R/R) epithelial ovarian, peritoneal, or fallopian tube cancer", will be presented on June 5, 2023, from 1:15 PM-4:15 PM CT and the poster discussion session will be on June 5, 2023, from 4:30 PM-6:00 PM CT.
"We are pleased to have the opportunity to share these exciting clinical data from our chemotherapy combination trial at ASCO (Free ASCO Whitepaper) this year. These encouraging clinical data, together with the preclinical data we recently presented at the 2023 AACR (Free AACR Whitepaper) Annual Meeting, provide clear support for the use of Cyclin E1 expression as a predictive marker to identify patients who may significantly benefit from treatment with azenosertib," said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "Importantly, these findings offer robust evidence that azenosertib restores chemotherapy sensitivity in Cyclin E1 positive cancers, which are known to be chemotherapy resistant."
The Company also announced today separate agreements with Foundation Medicine, Inc., an independent affiliate of the Roche Group, and with Roche Diagnostics. The current Foundation Medicine partnership involves global prospective genomic profiling for potential patient enrollment in Zentalis’ Phase 2 clinical trial of azenosertib in Cyclin E1 driven high-grade serous ovarian cancer. The companies are also exploring opportunities to develop Foundation Medicine’s tissue based next generation sequencing assay as a companion diagnostic for azenosertib. The Roche Diagnostics agreement is focused on the development of an immunohistochemistry-based clinical trial assay that evaluates Cyclin E1 protein levels and that can potentially identify a broader patient population with high protein expression in the absence of amplification.
"There continues to be a need for predictive markers for targeted therapeutics in difficult to treat malignancies such as platinum-resistant ovarian cancer," said Mark Lackner, Ph.D., Chief Translational Officer of Zentalis. "We are extremely happy to announce our partnerships with Foundation Medicine
and Roche Diagnostics to identify patients likely to benefit from treatment with azenosertib, our potentially first-in-class Wee1 inhibitor currently in clinical trials across a range of cancers."
About Azenosertib
Zentalis’ azenosertib (ZN-c3) has been designed to be a highly potent and selective Wee1 inhibitor.
Azenosertib is currently being evaluated in the clinic for advanced solid tumors and hematological malignancies in the following three therapeutic settings of high unmet medical need: (1) as a monotherapy, (2) in combination with traditional chemotherapy and DNA damaging agents, and (3) in combination with molecularly targeted agents. As a monotherapy, azenosertib is currently being evaluated in a Phase 2 clinical trial in adult women with uterine serous carcinoma (USC), an aggressive form of endometrial cancer that accounts for approximately 10-15% of all endometrial cancers. We are also evaluating azenosertib as a monotherapy in a Phase 2 clinical trial in patients with Cyclin E1 driven high-grade serous ovarian cancer (HGSOC). The Company is evaluating azenosertib as a monotherapy in a Phase 1 dose optimization clinical trial in patients with advanced solid tumors, and plans to declare the recommended Phase 2 monotherapy dose and provide an update on dose optimization activities in the first half of 2023. In chemotherapy combinations, azenosertib is currently being evaluated in combination with each of paclitaxel, carboplatin, pegylated liposomal doxorubicin (PLD) and gemcitabine in four cohorts in a Phase 1b clinical trial in patients with advanced platinum-resistant ovarian, peritoneal or fallopian tube cancer. The Company plans to disclose results from this study in the first half of 2023, in advance of original guidance. Azenosertib is also currently being evaluated in combination with gemcitabine in a Phase 1/2 clinical trial in adult and pediatric patients with relapsed or refractory osteosarcoma. In combination with molecularly targeted agents, the Company is studying azenosertib in combination with GlaxoSmithKline plc’s (GSK’s) PARP inhibitor, niraparib (ZEJULA), in a Phase 1/2 clinical trial in platinum-resistant ovarian cancer patients who have failed PARP inhibitor maintenance treatment as part of a clinical collaboration with GSK. The Company is also collaborating with Pfizer Inc. to evaluate azenosertib in combination with encorafenib and cetuximab, an FDA-approved standard of care known as the BEACON regimen, in patients with BRAF V600E mutant metastatic colorectal cancer in a Phase 1/2 clinical trial.