Date: 2016-10-31
Type of information: Clinical research agreement
Compound: tazemetostat - EPZ-6438 (E7438), pinometostat
Company: Epizyme (USA - MA) National Cancer Institute (USA)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: histone methyltransferase inhibitor/enzyme inhibitor. Tazemetostat is a first-in-class EZH2 inhibitor, and pinometostat is a first-in-class DOT1L inhibitor. Both investigational medicines target histone methyltransferases. These proteins are implicated in the development and regulation of cancer. Pinometostat is being developed in collaboration with Celgene. Epizyme retains all U.S. rights to pinometostat and has granted Celgene an exclusive license to pinometostat outside of the U.S.
Disease: hematologic malignancies, solid tumors including ovarian cancer
Details: * On October 31, 2016, Epizyme announced that it 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 and pinometostat. 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.
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