National Cancer Institute Sponsored Phase 1/1b clinical study to test combination of epigenetic and immune-oncology therapies in solid tumors and ovarian cancer
CALGARY, Alberta, Feb. 22, 2022 (GLOBE NEWSWIRE) -- Zenith Epigenetics Ltd. (“Zenith” or the “Company”) announced today the dosing of a first patient with a combination of ZEN-3694 (BET inhibitor) + Bristol Myers Squibb’s PD-1 immune checkpoint inhibitor OPDIVO and YERVOY, in a National Cancer Institute (NCI), part of the National Institutes of Health, sponsored trial in solid tumor cancer. The trial will be conducted by NCI funded investigators and will evaluate the safety and activity of this combination in patients with solid tumors that have become resistant to other therapies. This Phase 1/1b clinical trial will also evaluate a triple combination of ZEN-3694 + OPDIVO + YERVOY (an inhibitor of another immune checkpoints, CTLA4). Upon determination of a dosing regimen of the aforementioned double and triple combination, the trial will be expanded to ovarian cancer patients who have progressed on platinum-based chemotherapy.
“I am very excited to move this combination concept into the clinic through the National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP),” said Dr. Haider Mahdi, a principal investigator and medical oncologist at University of Pittsburgh Medical Center. “We have shown preclinically that BET inhibitors enhance the activity of checkpoint inhibitors by improving the tumor immune microenvironment. We expect the combination to be particularly effective in patients with MYC and BRD4 amplified ovarian cancer which has very poor outcomes and is difficult to treat.”
“We are very pleased that the NCI has initiated the first of several novel oncology clinical trials with ZEN-3694 based combinations,” said Donald J. McCaffery, President and CEO of Zenith Epigenetics. “This collaboration supplements our ongoing company sponsored Phase 2b trials in prostate cancer and breast cancer by significantly broadening the evaluation and development of ZEN-3694 into multiple other tumor types.”
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 various oncologic indications, specifically:
- Phase 2b metastatic castration resistant prostate (mCRPC) cancer trial in combination with androgen receptor inhibitor, XTANDI (enzalutamide), conducted in collaboration Astellas Pharma and Newsoara Biopharma.
- Phase 2b Triple Negative Breast Cancer (TNBC) trial in combination with the PARP inhibitor TALZENNA (talazoparib), conducted in collaboration with Pfizer and Newsoara Biopharma.
- Phase 1b/2 androgen receptor independent mCRPC trial in combination with immune checkpoint inhibitor KEYTRUDA (pembrolizumab) and XTANDI, conducted in collaboration with Merck, the University of California, San Francisco, and the University of Michigan.
- Phase 1/1b ovarian cancer trial in combination with immune-checkpoint inhibitors, nivolumab and ipilimumab, sponsored by the National Cancer Institute in collaboration with Zenith and BMS, under NCI’s Cooperative Research and Development Agreements with the two companies.
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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 development activities involving ZEN-3694 in combination with Bristol Myers Squibb’s Immune Checkpoint Inhibitor OPDIVO, and other targeted agents used in precision oncology, as week as other planned future immune-checkpoint based combination therapy clinical trials in other tumor types. 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.