To Evaluate the Combination of ZEN-3694 and Enzalutamide for Patients with Metastatic Castration-Resistant Prostate Cancer
CALGARY, Alberta, April 22, 2021 (GLOBE NEWSWIRE) -- Zenith Epigenetics Ltd. (“Zenith” or the “Company”), a clinical stage biotechnology company focused on the development of novel epigenetic combination therapies for the treatment of cancers, announces it has entered into an agreement with Astellas Pharma Inc. (“Astellas”) to evaluate ZEN-3694, Zenith’s leading BET inhibitor, in combination with Astellas and Pfizer’s androgen receptor inhibitor, XTANDI (enzalutamide), in patients with metastatic castration resistant prostate cancer (mCRPC).
Under the terms of the agreement, Zenith will sponsor and conduct a Phase 2b randomized study to evaluate the efficacy of the combination of ZEN-3694 and enzalutamide relative to single agent enzalutamide in mCRPC patients who have progressed on a prior androgen receptor signaling inhibitor (ARSi). Astellas will supply enzalutamide for the trial and Zenith will retain all rights to ZEN-3694. The clinical study is expected to start in Q2 2021.
“We are delighted to collaborate with Astellas to continue the development of ZEN-3694 in combination with enzalutamide in mCRPC patients, who are resistant to an ARSI,” said Donald McCaffrey, President and Chief Executive Officer of Zenith. “Data from our recently executed single arm Phase 1b/2a study has shown that the aforementioned combination may prolong radiographic progression free survival (rPFS) in mCRPC patients and particularly in a subset of patients who had a poor response to prior ARSi and whose tumors had low androgen receptor signaling activity. There is a significant unmet need in mCRPC patients who are ARSi resistant and their current treatment options only include chemotherapy with considerable side effects. We are looking forward to validating our initial clinical findings with this well-designed randomized study.”
About prostate cancer
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 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 low survival rates.
Zenith Capital Corp. is a biotechnology investment company originally spun out of Resverlogix Corp. (TSX: RVX) in 2013. 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 inhibitors with other targeted agents. The lead compound, ZEN-3694, is in clinical development for:
- mCRPC in combination with androgen receptor inhibitor, XTANDI, with Astellas and Newsoara as collaborators
- Triple Negative Breast Cancer in combination with the PARP inhibitor TALZENNA with Pfizer as a collaborator
- Androgen receptor independent mCRPC in combination with immune checkpoint inhibitor KEYTRUDA and XTANDI with University of California, San Francisco as a collaborator
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This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information relating to the Company’s upcoming Phase 2b randomized study to evaluate the efficacy of the combination of ZEN-3694 and enzalutamide relative to single agent enzalutamide in mCRPC patients who have progressed on a prior ARSi, the Company’s development of ZEN-3694 and its potential role in the treatment of cancer and other disorders. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. Zenith disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.