We are a late-stage biopharmaceutical company focused on the development and commercialization of our lead product candidate, entinostat, an epigenetic therapy for treatment-resistant cancers. In September 2013, entinostat was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration, or FDA, based on data from our completed randomized Phase 2b clinical trial in estrogen receptor positive, or ER+, locally recurrent or metastatic breast cancer. This trial showed statistically significant improvement in the primary endpoint of progression-free survival and showed statistically significant improvement in overall survival, an exploratory endpoint.
We and our collaborators at the National Cancer Institute (NCI) will evaluate entinostat in a pivotal Phase 3 clinical trial in hormone receptor positive locally advanced or metastatic breast cancer, which we refer to as advanced breast cancer. The Eastern Cooperative Oncology Group – American College of Radiology Imaging Network Cancer Research Group, is conducting the Phase 3 clinical trial under sponsorship and funding support from the NCI. We are supporting the Phase 3 clinical trial under a Cooperative Research and Development Agreement with the NCI and a separate agreement with the ECOG-ACRIN Cancer Research Group. The protocol for the Phase 3 clinical trial was reviewed and agreed upon by the FDA under a Special Protocol Assessment agreement with the NCI in January 2014. ECOG-ACRIN Cancer Research Group activated the trial in March 2014 with PFD data expected in mid-2017.
To develop entinostat for use as an immunomodulatory agent, we currently plan to conduct a Phase 1b clinical trial to examine the combination of entinostat with antibodies targeting programmed cell death protein 1, or PD1, or programmed cell death ligand 1, or PDL1, to characterize the safety, define a recommended Phase 2 dose and assess the preliminary clinical activity of this combination. In addition, we also plan to evaluate entinostat with other hormone therapies in breast cancer and with other immune therapies in lung and renal cancers. Additional investigator- and NCI-sponsored trials are being conducted to provide Phase 2 proof-of-concept data for entinostat in metastatic lung cancer and other solid and hematologic cancers.
To further enhance our breast cancer program, we intend to conduct a Phase 2 clinical trial to further study the association between a potential biomarker of entinostat activity and clinical outcome, which we identified in our previous trial. To date, we have efficacy and safety data for entinostat in approximately 900 patients.