Zenith Epigenetics Reports Advancement of ZEN-3694 in NUT Carcinoma

Calgary, Alberta--(Newsfile Corp. - June 1, 2023) - Zenith Epigenetics Ltd. (“Zenith” or the “Company”) reports clinical activity and the advancement in development of its BET inhibitor (BETi) ZEN-3694 in patients with NUT carcinoma (NC). NC is a highly aggressive type of squamous cell cancer with very poor prognosis that often forms in the head, neck, or lungs. There are currently no effective treatments for this devastating disease that primarily affects adolescents and young adults with a median survival of only 6 months. NC is considered underdiagnosed with an estimated 1100 cases going undiagnosed in the US every year. The diagnosis rate is increasing rapidly with growing awareness and analytical testing for this disease.

Zenith Epigenetics has provided ZEN-3694 to two NC patients for compassionate use and both experienced significant clinical benefit and durable reduction of their tumors. In one case ZEN-3694 was administered as a single agent and in another case in combination with chemotherapy.

Concurrently with compassionate use, ZEN-3694 is also being evaluated in two NUT carcinoma clinical trials sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), through the Cancer Therapy Evaluation Program (CTEP) under a Cooperative Research and Development Agreement (CRADA) between Zenith and the NCI. The first trial, NCT05019716, which combines ZEN-3694 with chemotherapy (etoposide/platinum), is active and recruiting patients. The second trial NCT05372640, is in the startup phase and combines ZEN-3694 with the CDK4/6 Inhibitor Abemaciclib. These combinations may increase the response rate and durability above that of either agent alone.

“We are very pleased that NUT carcinoma patients receiving ZEN-3694 for compassionate use have benefitted from our drug,” said Donald McCaffrey, CEO of Zenith Epigenetics. “We are also very optimistic that the ongoing clinical trials will show clinical benefit and improved quality of life to a patient population with such poor prognosis and no approved therapy options. Besides NUT carcinoma, ZEN-3694 is also currently being evaluated in multiple oncology indications including CRPC, breast cancer, ovarian cancer, colorectal cancer, and lung cancer in 11 clinical trials with various drug combinations. We continue to advance these programs with our partners and are committed to bring this important therapy to these patients.”

About NUT Carcinoma and BET inhibition

NUT carcinoma is driven by NUTM1 genetic alterations, most commonly fusion to BRD4 (bromodomain-containing protein 4) resulting in a fusion oncoprotein. ZEN-3694 is a BET bromodomain inhibitor that directly binds to NUT fusion proteins, disrupts their activity, and inhibits cancer growth. NUT carcinoma is diagnosed by testing tumor tissue for the fusion protein using immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) or by DNA sequencing to identify the NUT fusion oncogene.

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. Our lead compound, ZEN-3694, is in clinical development for various oncologic indications and several studies are sponsored by NCI under the NCI-Zenith CRADA and CRADAs between NCI and other NCI collaborators, specifically:

1. Phase 2b trial in patients with metastatic castration resistant prostate (mCRPC) cancer in combination with androgen receptor inhibitor, XTANDI (enzalutamide), conducted in collaboration with Astellas Pharma and Newsoara Biopharma. Zenith and Newsoara are the trial sponsors (NCT04986423).

2. Phase 2b trial in Triple Negative Breast Cancer (TNBC) patients in combination with the PARP inhibitor (PARPi) TALZENNA (talazoparib), conducted in collaboration with Pfizer and Newsoara Biopharma. Zenith and Newsoara are the trial sponsors (NCT03901469).

3. Phase 1b/2 trial in patients with androgen receptor independent mCRPC in combination with immune checkpoint inhibitor KEYTRUDA (pembrolizumab) and XTANDI (enzalutamide), conducted in collaboration with Merck, the University of California, San Francisco, and the University of Michigan (NCT04471974).

4. Phase 2 trial in combination with TALZENNA (talazoparib) in patients with recurrent ovarian cancer treated with prior PARPi, conducted by the University of Pittsburgh in collaboration with Zenith and Pfizer (NCT05071937).

5. Phase 2 trial in patients with advanced squamous cell lung cancer with NSD3 gene amplification, conducted by Memorial Sloan Kettering Cancer Center (NCT05607108).

6. Phase 1b/2 trial in solid tumors and ovarian cancer patients in combination with immune-checkpoint inhibitors, OPDIVO (nivolumab) and YERVOY (ipilimumab), conducted by the NCI in collaboration with Zenith and BMS (NCT04840589).

7. Phase 1b trial with KEYTRUDA (pembrolizumab) and ABRAXANE (Nab-Paclitaxel) in patients with metastatic TNBC conducted by the NCI in collaboration with Zenith and Merck. (NCT05422794).

8. Phase 2 trial with TALZENNA (talazoparib), in patients with molecularly-selected solid tumors such as PARPi resistant ovarian, prostate cancer, breast, and pancreatic cancers, and solid tumors with RAS pathway alterations conducted by the NCI in collaboration with Zenith and Pfizer (NCT05327010).

9. Phase 1 trial of with the MEK inhibitor MEKTOVI (binimetinib) in solid tumors with RAS pathway alterations and metastatic TNBC conducted by the NCI in collaboration with Zenith and Pfizer (NCT05111561).

10. Phase 1/2 trial with the histone deacetylase inhibitor Entinostat in advanced and refractory solid tumors and lymphomas conducted by the NCI in collaboration with Zenith and Syndax (NCT05053971).

11. Phase 1 trial in combination with Capecitabine in patients with metastatic unresectable colorectal cancer (CRC) conducted by the NCI (NCT05803382).

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 NUT carcinoma, prostate cancer, breast cancer, lung cancer, ovarian cancer, pancreatic cancer, lymphomas, colorectal cancer, and other tumor types, as a single agent, or in combination with chemotherapies, including etoposide/platinum, CDK4/6 inhibitors, PARP inhibitors, immune checkpoint inhibitors, androgen receptor inhibitors, MEK inhibitors, histone deacetylase inhibitors, antineoplastics, antimetabolites and other chemotherapy agents, 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.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.

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