CALGARY, Alberta, June 21, 2022 (GLOBE NEWSWIRE) -- Zenith Epigenetics Ltd. (“Zenith” or the “Company”) announced today that the data from its Phase 2 Metastatic Triple Negative Breast Cancer (mTNBC) clinical trial combining ZEN-3694 + Pfizer Inc.’s Talzenna (talazoparib) was highlighted at an oral session “Optimizing Targeted Therapies in Advanced Breast Cancer: Building on Past Success”. The discussant presented the novel concept of administering ZEN-3694, a bromodomain and extraterminal (BET) inhibitor (BETi), to sensitize resistant mTNBC tumors to talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), and the clinically meaningful response rate and manageable safety profile of the combination from the Phase 2 study. Selection of an abstract for an oral discussion is a very competitive process with only 24 of the more than 125 accepted abstracts selected for this presentation format. The poster can be viewed on Zenith Epigenetics’ website (Poster) and the discussion can be viewed on the ASCO website (Discussion).
“The data from the Phase 2 trial demonstrate that the ZEN-3694 plus talazoparib combination regimen, with a clinically meaningful response rate of 32% in a defined population, has the potential for treating patients whose tumors do not harbor germline mutations in BRCA1/2”, said Dr. Philippe Aftimos, a principal investigator and medical oncologist at The Institut Jules Bordet in Brussels, Belgium. “This combination is active with a manageable safety profile and warrants continued clinical evaluation”. Zenith has expanded the Phase 2 trial to continue to evaluate the combination in an additional 120 mTNBC patients (NCT03901469).
In conjunction with ASCO, Zenith’s TNBC poster was also awarded the GRASP Advocate Choice Award and selected to be discussed at the GRASP Poster Walkthroughs. GRASP, which stands for Guiding Researchers and Advocates for Scientific Partnerships, is a patient-led organization that brings together patients, clinicians, and researchers to exchange ideas and learn from each other to accelerate scientific breakthroughs. GRASP Poster Walkthroughs are small group discussions of selected posters presented at scientific conferences such as ASCO.
“We are very pleased that the data from our mTNBC clinical study, conducted in collaboration with Pfizer, was well received and recognized at ASCO”, said Don McCaffrey, CEO of Zenith Epigenetics. “The combination regimen of ZEN-3694 + talazoparib has shown promising clinical activity in a mTNBC patient population with significant unmet need. We continue to advance this program toward registration and are committed to bring an important therapy to these patients”.
About Zenith and ZEN-3694
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 with Astellas Pharma and Newsoara Biopharma. Zenith and Newsoara are the trial sponsors.
- Phase 2b Triple Negative Breast Cancer (TNBC) trial in combination with the PARP inhibitor TALZENNA (talazoparib), conducted in collaboration with Pfizer and Newsoara Biopharma. Zenith and Newsoara are the trial sponsors.
- 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 1b/2 ovarian cancer trial in combination with immune-checkpoint inhibitors, nivolumab and ipilimumab, conducted by the National Cancer Institute in collaboration with Zenith and BMS.
About Triple Negative Breast Cancer (“TNBC”)
TNBC is an aggressive form of breast cancer with low survival rates. TNBC accounts for about 10-15% of all breast cancers and it differs from other types of invasive breast cancer in that it tends to grow and spread faster, has fewer treatment options, and tends to have a worse prognosis. The term triple-negative breast cancer refers to the fact that the cancer cells have only low or no amount of the receptors ER, PR, and HER2. Approximately 75,000 women in the US, Japan and the major EU countries are diagnosed with TNBC each year.
About ZEN-3694 + Talazoparib Combination
In the United States, talazoparib is currently approved under the brand name TALZENNA, which is a PARP inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. ZEN-3694, in combination with talazoparib, is being developed for targeting tumors that do not have a germline BRCA mutation which represent approximately 89% of TNBC tumors. Preclinical and clinical data has shown that BET inhibition may reduce the levels of DNA repair proteins such as BRCA1/2 and RAD51 and thus create synthetic lethality in wildtype BRCA1/2 TNBC tumors when combined with PARP inhibition.
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 development activities involving ZEN-3694 in combination with Pfizer’s PARP inhibitor Talzenna, and other targeted agents used in precision oncology, as well as other planned PARPi 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.
