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Zenith Epigenetics Announces U.S. FDA Clearance of Investigational New Drug Application for ZEN-3694 in TNBC Program
[March 18, 2019]

Zenith Epigenetics Announces U.S. FDA Clearance of Investigational New Drug Application for ZEN-3694 in TNBC Program


Pfizer / Zenith TNBC program collaboration on target to dose first patient in April 2019

Phase 2 mCRPC program and clinical data to be presented at AACR

CALGARY, Alberta, March 18, 2019 (GLOBE NEWSWIRE) -- Zenith Epigenetics Ltd. (“Zenith” or the “Company”), a wholly-owned subsidiary of Zenith Capital Corp., announced today that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s investigational new drug application for ZEN-3694, a novel and differentiated  bromodomain and extra-terminal domain inhibitor (“BETi”), for triple negative breast cancer (“TNBC”) in combination with talazoparib, a poly ADP ribose polymerase inhibitor (“PARPi”).

As announced on November 20, 2018, Pfizer Inc. (“Pfizer”; NYSE: PFE) and Zenith are collaborating on a Phase 1b/2 clinical trial of ZEN-3694 and Pfizer’s PARPi, talazoparib, in patients with locally advanced or metastatic TNBC without germline BRCA1/2 mutations. First dosing is expected in April 2019.

“We are pleased with the continued clinical advancements with ZEN-3694 in diseases with significant unmet need,” said Donald McCaffrey, Chief Executive Officer of Zenith. “We look forward to the first dosing of patients in our collaboration trial with Pfizer, as well as future key clinical milestones. We are excited to be a leader in combination approaches with BETi and with ZEN-3694 as a best in class molecule.”

Zenith also announces the presentation of clinical data on its Phase 2 metastatic castration resistant prostate cancer (“mCRPC”) clinical study in combination with enzalutamide at the American Association for Cancer Research (“AACR”) Annual Meeting 2019, Atlanta, Georgia, USA. Zenith will be the first to release clinical combination data wit a BETi at a major scientific meeting.



AACR 2019, Atlanta, GA, USA

  • April 1, 2019
    • A phase 1b/2a study of the BET bromodomain inhibitor ZEN-3694 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer
    • The poster will be available on the Company’s website HERE at the appropriate time.

About Zenith:


Zenith Capital Corp. is a biotechnology investment company originally spun out of Resverlogix Corp. (TSX: RVX) in 2013. Zenith Epigenetics Ltd. (“Zenith”), 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 is developing various novel combinations of BET inhibitors with other targeted agents.

For further information, please contact:

Investor Relations & Communications                            

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

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 collaboration with Pfizer on a Phase 1b/2 TNBC clinical study, and the presentation of new data regarding its mCRPC program at AACR. 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 which are described our most recent MD&A which are incorporated 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. We disclaim any intention and have 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.                                            

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