Calgary, Alberta--(Newsfile Corp. - April 9, 2026) - Zenith Epigenetic Ltd. ("Zenith" or the "Company") today held its annual general meeting of shareholders ("AGM"), during which President & CEO Donald McCaffrey provided an update to investors on ZEN-3694's clinical development program for the treatment of NUT carcinoma. Highlights from the presentation are summarized below and a replay of the entire presentation may be found here.
Expanded Access Program
Zenith has an active expanded access program ("EAP") for NUT carcinoma, which provides patients with access to ZEN-3694 for compassionate use.
- 71 applications have been made to the Company originating from 21 countries around the world
- 28 patients have received ZEN-3694 through the program, alone or in combination with other drugs
- 2 patients who received both ZEN-3694 and abemaciclib had positive treatment responses (67% of those who received this combination)
- One with greater than 80% reduction in target lesion size
- One with greater than 80% reduction in tumor burden
Ongoing Clinical Studies
ZEN-3694 is undergoing clinical evaluation for the treatment of NUT carcinoma in two actively-enrolling clinical studies.
- NCT05372640, in combination with abemaciclib, has 24/40 participants enrolled
- NCT05019716, in combination with cisplatin & etoposide, has 18/55 participants enrolled
These studies are led by our collaborators at the National Cancer Institute ("NCI") and researchers at the Dana-Farber Cancer Institute ("DFCI") at Harvard University. Data from the two open-label studies have not yet been made public, but preliminary findings that the Company is aware of suggest treatment responses at recommended Phase 2 dose are in line with those seen among compassionate use patients.
Upcoming Milestones
The Company announced its intention to move ZEN-3694's NUT carcinoma development program in-house by filing an Investigational New Drug ("IND") application with the US Food and Drug Administration ("FDA"). The filing will enable Zenith to directly sponsor a planned Phase 3 study of ZEN-3694 in combination with abemaciclib for the treatment of NUT carcinoma and give the company more control over the pace of study progression and the preparation of critical documents for an eventual New Drug Application ("NDA") submission. The Company believes that bringing the NUT carcinoma program in-house will accelerate the development of ZEN-3694, shortening and de-risking its path towards marketing approval.
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/291822
Source: Zenith Capital Corp.
