Zenith Epigenetics Announces Clinical Collaboration with Astellas 

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.

About Zenith

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:

1. mCRPC in combination with androgen receptor inhibitor, XTANDI, with Astellas and Newsoara as collaborators
2. Triple Negative Breast Cancer in combination with the PARP inhibitor TALZENNA with Pfizer as a collaborator
3. Androgen receptor independent mCRPC in combination with immune checkpoint inhibitor KEYTRUDA and XTANDI with University of California, San Francisco as a collaborator

For further information, please contact:

Investor Relations & Communications                        

Zenith Epigenetics
Phone: 587-390-7865
Email: info@zenithepigenetics.com         
Website: www.zenithepigenetics.com