Zenith Epigenetics Ltd. reported 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. Conccurrently 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.