Zenith Epigenetics Announces Start of Several National Cancer Institute (NCI)-Sponsored Oncology Clinical Trials Seven NCI sponsored trials will evaluate safety and efficacy of its BET inhibitor (BETiBET inhibitor (BETi) ZEN-3694 in combination with several targeted agents and/or chemotherapy in several solid tumor types with significant unmet need CALGARY, Alberta, July 06, 2022 (GLOBE NEWSWIRE) -- Zenith Epigenetics Ltd. (“Zenith” or the “Company”) announced today that its leading BET inhibitorBET inhibitor, ZEN-3694, is being evaluated in seven NCI sponsored clinical trials for safety and efficacy in multiple oncology indications with significant unmet need, through the NCI’s Cancer Therapy Evaluation Program (CTEP) under a collaboration between Zenith and NCI, part of the National Institutes of Health. These trials are being conducted by leading investigators and institutions funded by the NCI in the United States and are based on strong pre-clinical rationale for anti-cancer drug combination regimens incorporating ZEN-3694 in advanced and metastatic tumors that are resistant to other therapies. BETis, like ZEN-3694, have been shown in pre-clinical pharmacology studies to sensitize tumors resistant to targeted agents through epigenetic modulation, hence the significant interest in evaluating several such combination therapies. Three of the aforementioned trials are accruing patients, with the remaining five pending activation in the next few months. A rich translational program is embedded in each trial to validate the mechanism of action and identify markers of response and resistance. Combination with immune-checkpoint inhibitors
NCT04840589 (enrolling) A Phase I/Ib Trial Evaluating the Safety and Efficacy of BET InhibitorBET Inhibitor, ZEN003694 With PD-1 InhibitorPD-1 Inhibitor, Nivolumab With or Without CTLA-4 InhibitorCTLA-4 Inhibitor, Ipilimumab in Solid Tumors is evaluating the combination of ZEN-3694 + BMS’s immune-checkpoint inhibitors, Opdivo and Yervoy, in patients with advanced or metastatic solid tumors and wildtype BRCA, platinum resistant ovarian cancer. To date, checkpoint inhibitor trials have had limited success in ovarian cancer, and there are few options after patients progress on targeted therapies. ZEN-3694 has been shown preclinically to address several mechanisms of resistance to checkpoint inhibitors, and may sensitize tumors to the checkpoint combination. The trial is being led by Haider S. Mahdi, MD, Assistant Professor of Obstetrics, Gynecology & Reproductive Sciences at the University of Pittsburgh. NCT05327010 A Phase 2 Trial of the Combination of the BET InhibitorBET Inhibitor, ZEN003694 (ZEN-3694), and the PARP InhibitorPARP Inhibitor Talazoparib, in Patients With Molecularly-Selected Solid Tumors (ComBET) will evaluate the combination of ZEN-3694 plus talazoparib in additional indications such as PARPi resistant ovarian, prostate cancer, breast, and pancreatic cancers, and solid tumors with Ras alterations. This trial builds on the proof of concept shown in Zenith Epigenetics' mTNBC trial (NCT03901469) by expanding into additional indications where PARPi are utilized. BETi including ZEN-3694 has been shown to sensitize germline BRCA wild-type tumors to PARPi, by creating a “BRCAness” phenotype and reverse acquired resistance to PARPi in pre-clinical models. The trial will be led by Timothy A Yap, MBBS PhD FRCP, Associate Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. “We are very pleased with our collaboration with the NCI and that ZEN-3694 will be evaluated in additional oncology indications”, said Don McCaffrey, CEO of Zenith Epigenetics. “In addition to expanding the ZEN-3694 PARPi and the ZEN-3694 immune-checkpoint combination to reach additional patients, ZEN-3694’s potential as a combination agent in several different patient populations with a significant unmet need will also be evaluated. The level of interest by leading investigators and the NCI underscore the potential of ZEN-3694 in multiple oncology indications. We continue to advance ZEN-3694 toward registration and are committed to bring an important therapy to cancer patients”. Zenith Epigenetics Ltd., a wholly-owned subsidiary of Zenith Capital Corp., is a clinical stage biotechnology company focused on the discovery and development of novel therapeutics for the treatment of cancer and other disorders with significant unmet medical need. Zenith Epigenetics is developing various novel combinations of BET inhibitorsBET inhibitors with other targeted agents. The lead compound, ZEN-3694, is in clinical development for various oncologic indications in addition to the clinical trials mentioned above, specifically: TNBC is an aggressive form of breast cancer with low survival rates. TNBC accounts for about 10-15% of all breast cancers and it differs from other types of invasive breast cancer in that it tends to grow and spread faster, has fewer treatment options, and tends to have a worse prognosis. The term triple-negative breast cancer refers to the fact that the cancer cells have only low or no amount of the receptors ER, PR, and HER2. Approximately 75,000 women in the US, Japan and the major EU countries are diagnosed with TNBC each year. Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide. Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone and to ARSIs that block AR signaling, disease progression ultimately occurs leading to mCRPC. The treatment of prostate cancer patients has evolved rapidly over the past ten years with second generation ARSIs. Despite these advances, many patients with mCRPC fail or develop resistance to existing treatments, leading to continued disease progression and limited survival rates In the US epithelial ovarian cancer is the fifth most common cause of cancer death in women and the most common gynecologic malignancy with about half of women being diagnosed over 65 years of age often with advanced disease. Although primary treatment is effective, most women will relapse and develop resistance to conventional agents. For further information, please contact:
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