Zenith Epigenetics

About Zenith Epigenetics

Zenith Epigenetics is a clinical-stage biotechnology company operating as a wholly-owned subsidiary of Zenith Capital Corp., a biotechnology investment firm founded in 2013 by Donald J. McCaffrey. Spun out from Resverlogix Corp. in 2013, Zenith Epigenetics is dedicated to developing novel therapeutics for cancer and other disorders by focusing on the field of epigenetics. The company's business model revolves around the discovery and clinical development of its proprietary bromodomain and extra-terminal (BET) inhibitors, aiming to monetize these assets through partnerships, licensing agreements, or potential sale of the company. Funding is secured through private placements to support research, development, and general corporate operations.

The company is led by President and CEO Donald J. McCaffrey, who brings over two decades of experience in drug discovery and development and also leads Resverlogix. The management team includes experts in pharmacology, business development, and operations who have been instrumental in establishing key collaborations. Zenith's business strategy involves partnering with major pharmaceutical companies, research institutions, and government bodies to advance its clinical programs. Notable collaborators include Pfizer, Merck, the National Cancer Institute (NCI), and various universities. These partnerships provide resources and expertise to evaluate Zenith's lead compound in multiple oncology indications.

Zenith's core product is ZEN-3694, an orally administered, pan-selective BET inhibitor. This drug works by targeting epigenetic reader proteins (BRD2, BRD3, BRD4, BRDT) that regulate the expression of oncogenes, which are genes that can cause cancer. A key feature of ZEN-3694 is its potential to re-sensitize tumors that have become resistant to other targeted therapies. By modulating the epigenetic environment, it can make cancer cells susceptible to treatments that were previously ineffective. For instance, in preclinical studies, it has shown an ability to make cancer cells in patients without BRCA mutations respond to PARP inhibitors, a class of drugs typically effective only in patients with those mutations. The company is developing ZEN-3694 in combination therapies for various cancers, including metastatic castration-resistant prostate cancer (mCRPC), NUT carcinoma, breast cancer, and ovarian cancer. In July 2025, the FDA granted Fast Track designation to ZEN-3694 in combination with abemaciclib for treating metastatic or unresectable NUT carcinoma, a significant milestone expected to accelerate its development and review process.