Epizyme, Inc. has entered into two Cooperative Research and Development Agreements (CRADAs) with the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). The CRADAs will evaluate tazemetostat, Epizyme’s first-in-class EZH2 inhibitor, and pinometostat, the Company’s first-in-class DOT1L inhibitor. Both investigational medicines target proteins implicated in the development and regulation of cancer.
“This collaboration reflects Epizyme’s strategy to enhance our development programs through impactful partnerships,” said Peter Ho, M.D., Ph.D., Chief Medical Officer, Epizyme. “These CRADAs broaden the scope of our ongoing tazemetostat clinical program to explore its potential benefit in a wider range of cancer indications. We are also excited to continue the exploration of pinometostat’s potential utility in treating acute leukemias in combination regimens. We look forward to generating additional data to advance our epigenetic pipeline of novel therapies for patients with cancer.”
As part of the CRADA for tazemetostat, CTEP will collaborate with Epizyme in clinical trials to evaluate the safety and efficacy of tazemetostat in patients with hematologic malignancies and solid tumors. The initial NCI-sponsored study will evaluate tazemetostat in a phase 2 clinical trial in patients with ovarian cancer. External publications and Epizyme preclinical data indicate that inhibition of EZH2 could be beneficial in subsets of ovarian cancer.
Under the second CRADA, the safety and efficacy of pinometostat will be evaluated in patients with acute leukemias. Initial studies will evaluate the combination of pinometostat with standard-of-care therapies or targeted agents in acute myeloid leukemia, acute lymphoid leukemia, or mixed lineage leukemia characterized by a rearrangement in the mixed lineage leukemia gene (MLL-r). Preclinical studies of pinometostat in MLL-r cell line models have shown synergy with chemotherapies, including acute leukemia standard-of-care agents and select targeted therapies.
As part of both agreements, additional clinical trials will be considered. NCI will predominantly fund the studies and manage study operations.