Zenith Epigenetics Announces Clinical Collaboration with Astellas

Zenith Epigenetics Ltd. a clinical stage biotechnology company focused on the development of novel epigenetic combination therapies for the treatment of cancers, announces it has entered into an agreement with Astellas Pharma Inc. to evaluate ZEN-3694, Zenith’s leading BET inhibitor, in combination with Astellas and Pfizer’s androgen receptor inhibitor, XTANDI (enzalutamide), in patients with metastatic castration resistant prostate cancer (mCRPC).

Under the terms of the agreement, Zenith will sponsor and conduct a Phase 2b randomized study to evaluate the efficacy of the combination of ZEN-3694 and enzalutamide relative to single agent enzalutamide in mCRPC patients who have progressed on a prior androgen receptor signaling inhibitor (ARSi). Astellas will supply enzalutamide for the trial and Zenith will retain all rights to ZEN-3694. The clinical study is expected to start in Q2 2021.

“We are delighted to collaborate with Astellas to continue the development of ZEN-3694 in combination with enzalutamide in mCRPC patients, who are resistant to an ARSI,” said Donald McCaffrey, President and Chief Executive Officer of Zenith. “Data from our recently executed single arm Phase 1b/2a study has shown that the aforementioned combination may prolong radiographic progression free survival (rPFS) in mCRPC patients and particularly in a subset of patients who had a poor response to prior ARSi and whose tumors had low androgen receptor signaling activity. There is a significant unmet need in mCRPC patients who are ARSi resistant and their current treatment options only include chemotherapy with considerable side effects. We are looking forward to validating our initial clinical findings with this well-designed randomized study.”