Syndax is a clinical stage biopharmaceutical company developing entinostat as a combination therapy in multiple cancer indications with an initial focus on tumors that have shown sensitivity to immunotherapy, including lung cancer, melanoma and triple negative breast cancer. Entinostat is an oral, small molecule drug candidate that has direct effects on both cancer cells and immune regulatory cells, potentially enhancing the body’s immune response to tumors.
Syndax is working in collaboration with Merck to study the combination of entinostat with Merck’s Keytruda® (pembrolizumab) in a Phase 1b/2 clinical trial of patients with non-small cell lung cancer or melanoma. The Phase 1b portion of the clinical trial will evaluate the safety and tolerability of the combination of entinostat and Keytruda and the Phase 2 portion of the clinical trial will assess the efficacy of entinostat combined with Keytruda in patients with either non-small cell lung cancer or melanoma. Syndax has also entered into a collaboration with Genentech to evaluate the safety, tolerability and preliminary efficacy of entinostat in combination with Genentech’s atezolizumab in a Phase 1b/2 clinical trial of patients with triple negative breast cancer.
Additionally, Syndax is providing financial and operational support for an ongoing Phase 3 clinical trial in advanced HR+ breast cancer in combination with Aromasin (exemestane). The Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (ECOG-ACRIN) is conducting this clinical trial under sponsorship and funding support from the National Cancer Institute (NCI). The Phase 3 clinical trial is designed to determine whether the addition of entinostat to Aromasin (exemestane) improves progression-free survival, overall survival, or both in patients who have previously progressed after treatment with standard-of-care hormonal agents.
Additional NCI- and investigator-sponsored combination clinical trials of entinostat and immuno-oncology agents in solid tumors further establish Syndax’s broad immune-directed program.