On July 14, 2025 Zenith Epigenetics Ltd. ("Zenith" or the "Company") reported the designation of ZEN-3694 as a Fast Track product by the U.S. Food and Drug Administration ("FDA") (Press release, Zenith Epigenetics, JUL 14, 2025, View Source [SID1234657190]). FDA officials concluded that ZEN-3694, in combination with abemaciclib, meets the criteria for Fast Track designation for the treatment of metastatic or unresectable NUT carcinoma in patients who have received at least one line of prior chemotherapy. The Company is also pursuing Orphan Drug and Breakthrough Therapy designations for ZEN-3694 in NUT carcinoma.

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"We are thrilled that the FDA has recognized the strong potential of ZEN-3694 in benefiting patients with NUT carcinoma, an extremely aggressive, deadly cancer, for which there are no effective or approved treatments," said Donald McCaffrey, President & CEO of Zenith Epigenetics. "Fast Track designation will accelerate ZEN-3694’s clinical NUT carcinoma program by expediting its development and review, and allow us to deliver this potentially life-saving drug to patients sooner."

Fast Track Designation

According to the FDA, Fast Track "is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need". The purpose of the Fast Track program is to speed up the development of important new drugs and get them into the hands of patients earlier than would otherwise be possible.

Benefits of Fast Track designation may include:

More frequent meetings with FDA on drug development planning
More frequent written communication from FDA on clinical trial design and other critical points
Eligibility for Accelerated Approval and Priority Review
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.