On April 12, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported a clinical collaboration agreement with GlaxoSmithKline ("GSK") in which Zentalis will evaluate the combination of ZN-c3, Zentalis’ oral WEE1 inhibitor product candidate, and ZEJULA (niraparib), GSK’s poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with advanced epithelial ovarian cancer (Press release, Zentalis Pharmaceuticals, APR 12, 2021, View Source [SID1234643100]). Zentalis is currently conducting clinical studies with ZN-c3 both as a monotherapy and in combination with certain standard of care therapies.
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"This clinical collaboration and supply agreement with GSK allows us to investigate the broader potential of our WEE1 inhibitor when used as part of a combination treatment with niraparib, a PARP inhibitor," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis Pharmaceuticals. "As demonstrated in our preclinical studies, ZN-c3 is designed to have significant advantages over other investigational WEE1 inhibitor therapies. We believe this combination has the potential to meaningfully improve the outcomes for patients with ovarian cancer."
PARP inhibitors prevent DNA damage repair in cancer cells. Similar to PARP, WEE1 plays a role in cellular regulation and repair, allowing cells with DNA damage to repair and survive. Inhibition of WEE1 causes dysregulation of DNA replication and subsequently induces apoptosis. Based on these complementary mechanisms of action, the use of WEE1 and PARP inhibitors could potentially have synergistic anti-tumor activity.
More than 300,000 women worldwide are diagnosed with ovarian cancer each year, leading to over 180,000 fatalities1. While substantial progress has been made in the treatment of this disease, there is an urgency to address the remaining unmet need through the development of innovative combination treatments.
Under the terms of the non-exclusive collaboration, Zentalis is responsible for conducting the study with GSK providing all required doses of niraparib. Zentalis maintains full ownership of ZN-c3.
1www.cancerresearch.org
About ZN-c3
ZN-c3 is an oral inhibitor of WEE1 in development for the treatment of advanced solid tumors. The inhibition of WEE1, a DNA damage response protein, aims to generate sufficient DNA damage in cancer cells, causing cell death, thereby preventing tumor growth and potentially causing tumor regression. Zentalis is currently conducting a Phase 1/2 clinical trial in patients with advanced solid tumors and reported initial data from the Phase 1 portion at the AACR (Free AACR Whitepaper) Annual Meeting 2021. In addition, the Company is also conducting a Phase 1b trial evaluating ZN-c3 in combination with chemotherapy in patients with advanced ovarian cancer, with plans to initiate a Phase 1/2 trial in combination with GSK’s niraparib in patients with advanced ovarian cancer, a Phase 1/2 trial in combination with chemotherapy in osteosarcoma and a Phase 2 trial investigating ZN-c3 as a monotherapy in patients with uterine serous carcinoma in 2021.
About ZEJULA (niraparib)
GSK’s ZEJULA (niraparib) is an FDA and EMA-approved oral, once-daily poly (ADP-ribose) polymerase inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies, including Phase III studies in ovarian and non-ovarian indications.