Merck to Collaborate with UCSF and Zenith in a New Phase 2 mCRPC Clinical Trial
CALGARY, Alberta, July 29, 2020 (GLOBE NEWSWIRE) -- Zenith Epigenetics Ltd. (“Zenith” or the “Company”) announced today significant clinical advances of ZEN-3694, the Company’s lead therapeutic compound being developed for epigenetic combination therapies in multiple oncology indications.
“Merck, Pfizer, UCSF and Newsoara now form an impressive list of collaborators involved in our development of ZEN-3694 in epigenetic combination therapy programs. We have made significant progress with ZEN-3694 towards multiple registration-enabling studies,” said Donald McCaffrey, President and CEO of Zenith. “I am extremely pleased to report that the newest Phase 2 prostate cancer trial, involving ZEN-3694, is a triple combination clinical study – combining our BET inhibitor, ZEN-3694, Pfizer’s enzalutamide (Xtandi) and Merck’s pembrolizumab (Keytruda), led by UCSF as the principle investigator. This is an exciting novel approach of regulating certain cancer gene expression, addressing targeted therapy resistance and working in concert with the body’s own immune system, respectively. It is clear that our differentiated and leading BET inhibitor, ZEN-3694, is safe and active and able to combine with multiple targeted agents used in today’s precision oncology market.
“In addition, we are also making very good progress with our ongoing Triple Negative Breast Cancer (TNBC) trial with our partner, Pfizer. The trial is progressing very well and should be fully enrolled within a month. We look forward to presenting ongoing study results at future conferences.”
Metastatic Castration Resistant Prostate Cancer (mCRPC) – Immune-Oncology Combination; UCSF / Zenith / Merck Collaboration
A University of California San Francisco (UCSF) principal investigator led Phase 2 clinical trial in collaboration with Zenith and Merck is being initiated in mCRPC patients who have progressed on an androgen receptor signaling inhibitor (ARSi) and includes patients whose tumors are no longer dependent on androgen receptor signaling. These ARSI independent patients do not benefit from a second ARSi and are in need for alternate therapies. In this study patients will be dosed with a triple combination of ZEN-3694, Merck’s PD-1 antibody, pembrolizumab, and Pfizer’s ARSi, enzalutamide. Pre-clinical data has shown that ZEN-3694 has synergistic immune-oncologic activity with pembrolizumab in various models.
Additional information on this study can be found HERE.
The above study is in addition to the Company’s mCRPC program combining ZEN-3694 + enzalutamide which recently completed Phase 2a and is planned for further development with Newsoara BioPharma Co., Ltd. as collaborator.
Triple Negative Breast Cancer (TNBC) – PARPi Combination; Pfizer Collaboration
The TNBC collaboration study, combining ZEN-3694 with Pfizer’s talazoparib, a poly ADP ribose polymerase inhibitor (PARPi), has progressed to Phase 2 of this Phase1b/2 trial. Clinical data to date shows that the combination is active and well tolerated. Ongoing results from this study will be presented at a major scientific conference later this year. Additional information on the study can be accessed HERE.
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 metastatic Castration Resistant Prostate Cancer (“mCRPC”) and Triple Negative Breast Cancer.
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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 progress in the development of ZEN-3694 towards registration enabling studies, ability of ZEN-3694 to successfully combine with other targeted agents used in precision oncology, timing of a phase 2 clinical trial in collaboration with Pfizer being fully enrolled, further development plans of ZEN-3694 with Newsoara as collaborator and the presentation of data at major conferences from an ongoing TNBC clinical trial collaboration with Pfizer. 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.