Calgary, Alberta--(Newsfile Corp. - October 8, 2026) - Zenith Epigenetics Ltd. ("Zenith" or the "Company") today announced that the Company has received clearance from the US Food and Drug Administration ("FDA") to sponsor a registration enabling study for ZEN-3694, the Company's clinical oncology candidate, for the treatment of NUT carcinoma. Zenith and the FDA concur on the design of the randomized trial, which will compare the combination of ZEN-3694 and a CKD4/6 inhibitor to the best available therapy (chemotherapy regimen), and is expected to begin in early 2027. The clearance follows the Company's successful Investigational New Drug ("IND") application.
"Receiving clearance and reaching consensus on the design of a registration enabling trial mark significant milestones in our clinical development," said Donald McCaffrey, President & CEO of Zenith Epigenetics. "Proof of concept studies have shown that the combination of ZEN-3694 and a CKD4/6 inhibitor has clinical efficacy with a manageable safety profile. We are excited to advance with a study designed to confirm these benefits, which will allow us to seek approval to register and market the product."
Ongoing Clinical Studies
ZEN-3694 is undergoing clinical evaluation for the treatment of NUT carcinoma in two actively enrolling clinical studies, led by our collaborators at the National Cancer Institute ("NCI") and researchers at the Dana-Farber Cancer Institute at Harvard University.
NUT Carcinoma
NUT carcinoma is a highly aggressive type of cancer affecting adults and children and typically occurs in the midline area of the body including head, neck, and thoracic areas. While NUT carcinoma is a rare cancer, it is currently underdiagnosed - due to lack of awareness and testing - and the actual incidence is estimated at 10,000 cases per year. However, growing awareness among clinicians, as well as new biomarker testing methods, are improving detection. With rapidly increasing diagnoses, no approved therapies, and a median overall survival of about 6 months, there is a significant unmet need for new therapeutic options in NUT carcinoma.
ZEN-3694
Zenith's lead clinical candidate, ZEN-3694, is currently being evaluated in two (2) active NUT carcinoma clinical trials in combination with abemaciclib (ClinicalTrials.gov ID: NCT05372640) and cisplatin & etoposide (ClinicalTrials.gov ID: NCT05019716). ZEN-3694 is a potent, selective, orally available BET inhibitor, which is well tolerated for chronic administration and has a favorable safety profile, with more than 550 patients having received the drug. In NUT carcinoma, the NUTM1 gene is fused with a transcriptional regulator - most commonly a BET protein - and drives expression of cancer-causing genes, leading to unchecked growth of tumors. Through disrupting the activity of NUT fusion protein, ZEN-3694 has demonstrated both single-agent and combination efficacy in treating NUT carcinoma. To date, the combination of abemaciclib plus ZEN-3694 has shown superior response rate and duration of response compared to single agent BET inhibitors by inhibiting resistance to therapy. ZEN-3694 has received FDA Fast Track and Orphan Drug designations for its NUT carcinoma program.
About Zenith
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. Our lead compound, ZEN-3694, is in clinical development for various oncologic indications such as metastatic castration resistant prostate cancer, NUT carcinoma, ovarian cancer, colorectal cancer, breast cancer, squamous cell lung cancer and other solid tumors. Several of these studies are sponsored by the NCI under the NCI-Zenith Cooperative Research & Development Agreements ("CRADA") and CRADAs between NCI and other NCI collaborators.
Forward-Looking Statement
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 NUT carcinoma, prostate cancer, ovarian cancer, lung cancer, breast cancer, colorectal cancer, and other tumor types, as a single agent, or in combination with chemotherapies, as well as our partnerships, agreements, and collaborations in furtherance of these development activities. 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.sedarplus.ca. 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.
For further information, please contact:
Investor Relations
Phone: 587-390-7865
Email: info@zenithepigenetics.com
Website: www.zenithepigenetics.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/318045
"Receiving clearance and reaching consensus on the design of a registration enabling trial mark significant milestones in our clinical development," said Donald McCaffrey, President & CEO of Zenith Epigenetics. "Proof of concept studies have shown that the combination of ZEN-3694 and a CKD4/6 inhibitor has clinical efficacy with a manageable safety profile. We are excited to advance with a study designed to confirm these benefits, which will allow us to seek approval to register and market the product."
Ongoing Clinical Studies
ZEN-3694 is undergoing clinical evaluation for the treatment of NUT carcinoma in two actively enrolling clinical studies, led by our collaborators at the National Cancer Institute ("NCI") and researchers at the Dana-Farber Cancer Institute at Harvard University.
- NCT05372640, in combination with a CKD4/6 inhibitor
- NCT05019716, in combination with cisplatin & etoposide
NUT Carcinoma
NUT carcinoma is a highly aggressive type of cancer affecting adults and children and typically occurs in the midline area of the body including head, neck, and thoracic areas. While NUT carcinoma is a rare cancer, it is currently underdiagnosed - due to lack of awareness and testing - and the actual incidence is estimated at 10,000 cases per year. However, growing awareness among clinicians, as well as new biomarker testing methods, are improving detection. With rapidly increasing diagnoses, no approved therapies, and a median overall survival of about 6 months, there is a significant unmet need for new therapeutic options in NUT carcinoma.
ZEN-3694
Zenith's lead clinical candidate, ZEN-3694, is currently being evaluated in two (2) active NUT carcinoma clinical trials in combination with abemaciclib (ClinicalTrials.gov ID: NCT05372640) and cisplatin & etoposide (ClinicalTrials.gov ID: NCT05019716). ZEN-3694 is a potent, selective, orally available BET inhibitor, which is well tolerated for chronic administration and has a favorable safety profile, with more than 550 patients having received the drug. In NUT carcinoma, the NUTM1 gene is fused with a transcriptional regulator - most commonly a BET protein - and drives expression of cancer-causing genes, leading to unchecked growth of tumors. Through disrupting the activity of NUT fusion protein, ZEN-3694 has demonstrated both single-agent and combination efficacy in treating NUT carcinoma. To date, the combination of abemaciclib plus ZEN-3694 has shown superior response rate and duration of response compared to single agent BET inhibitors by inhibiting resistance to therapy. ZEN-3694 has received FDA Fast Track and Orphan Drug designations for its NUT carcinoma program.
About Zenith
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. Our lead compound, ZEN-3694, is in clinical development for various oncologic indications such as metastatic castration resistant prostate cancer, NUT carcinoma, ovarian cancer, colorectal cancer, breast cancer, squamous cell lung cancer and other solid tumors. Several of these studies are sponsored by the NCI under the NCI-Zenith Cooperative Research & Development Agreements ("CRADA") and CRADAs between NCI and other NCI collaborators.
Forward-Looking Statement
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 NUT carcinoma, prostate cancer, ovarian cancer, lung cancer, breast cancer, colorectal cancer, and other tumor types, as a single agent, or in combination with chemotherapies, as well as our partnerships, agreements, and collaborations in furtherance of these development activities. 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.sedarplus.ca. 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.
For further information, please contact:
Investor Relations
Phone: 587-390-7865
Email: info@zenithepigenetics.com
Website: www.zenithepigenetics.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/318045
