“Coming together is a beginning…Working together is success.” – Henry Ford
Syndax is very interested in pursuing innovative explorations in science. If you are interested in collaborating with us, please contact us through [email protected].
Syndax’s oncology candidate entinostat is currently being studied in clinical trials across a broad range of solid tumors, including breast cancer, non-small cell lung cancer, or NSCLC, renal cell carcinoma and ovarian cancer. We believe entinostat’s well-characterized safety profile and mechanism of action allows it to be readily combined with, and thereby enhance the activity of, conventional and novel cancer therapies, such as immune checkpoint inhibitors, hormone therapies and chemotherapies.
We are focused on developing entinostat for use in multiple cancer indications in combination with complementary therapeutic drugs. Key elements of our strategy include: establishing entinostat as the combination therapy of choice with immune checkpoint inhibitors, initially programmed cell death protein 1, or PD-1, and programmed cell death protein ligand 1, or PDL-1, inhibitors; and pursuing regulatory approval of entinostat in indications with significant unmet need and commercial potential.
We are working in collaboration with Merck & Co. Inc., to study the combination of entinostat with Merck’s immune checkpoint inhibitor, KEYTRUDA® (pembrolizumab), in a Phase 1b/2 clinical trial, ENCORE 601, in patients with NSCLC or melanoma. Patient enrollment was initiated in the Phase 1b portion of the clinical trial in August 2015, which will evaluate the safety and tolerability of the combination of entinostat and KEYTRUDA®. The Phase 2 portion of the clinical trial will assess the efficacy of entinostat combined with KEYTRUDA® in patients with either NSCLC or melanoma.
We have also entered into a collaboration with Genentech, Inc. to evaluate the safety, tolerability and preliminary efficacy of entinostat in combination with Genentech’s investigational immune checkpoint inhibitor, atezolizumab, in a Phase 1b/2 clinical trial, ENCORE 602, in patients with triple negative breast cancer, or TNBC.
Additionally, we have entered into a collaboration with a subsidiary of Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the safety, tolerability and preliminary efficacy of entinostat in combination with an investigational monoclonal antibody targeting PDL-1, avelumab, in a Phase 1b/2 clinical trial, ENCORE 603, in patients with ovarian cancer. Avelumab is the proposed International Non-proprietary Name for the anti-PDL-1, IgG1 monoclonal antibody (MSB0010718C).
Entinostat is also being evaluated in two ongoing and one planned investigator-sponsored clinical trials that are designed to provide further validation of entinostat’s immuno-modulatory activity in various other immuno-responsive tumors.
Furthermore, we are providing financial and operational support for an ongoing Phase 3 clinical trial in advanced hormone receptor positive, or HR+, breast cancer in combination with Aromasin® (exemestane tablets). ECOG-ACRIN Cancer Research Group is conducting this clinical trial under sponsorship and funding support from the National Cancer Institute. The Phase 3 clinical trial is designed to determine whether the addition of entinostat to Aromasin improves progression-free survival, overall survival, or both in patients who have previously progressed after treatment with standard-of-care hormonal agents. We believe that the submission of the results of the Phase 3 clinical trial, if successful, would be sufficient for regulatory approval of entinostat in the United States.
We believe that there may be further opportunities through these and additional collaborations to expand the indications in which entinostat may target immunologic mechanisms of resistance to cancer therapies.