Syndax Pharmaceuticals is a late-stage oncology company supported by top venture capitalists and led by industry experts developing treatments for large markets including metastatic breast and lungcancer. The Company’s platform is based on employing epigenetics to overcome the problem of resistance in oncology care. Syndax holds worldwide rights to entinostat, an oral, highly selective histone deacetylase (HDAC) inhibitor, which inhibits cancer-relevant HDAC enzymes which contribute to epigenetic alterations driving cancer growth and drug tolerance.
Entinostat’s unique pharmacokinetic properties, convenient oral dosing and HDAC selectivity, maximize the opportunity to safely combine with and potentially extend the benefit of proven cancer therapies. Entinostat has demonstrated promising activity in randomized, phase 2 clinical trials in combination with the targeted therapies.
Syndax is focused on employing epigenetic strategies to overcome the problem of resistance in oncology care in solid tumors. A randomized, placebo-controlled Phase 2 study of entinostat in combination with aromatase inhibitors in breast cancer (ENCORE 301) demonstrated an improvement in both progression-free survival and overall survival, providing the basis for the evaluation of entinostat in pivotal Phase 3 testing in metastatic breast cancer.
Entinostat also demonstrated promising results in a subset of non-small cell lung cancer patients when given in combination with the EGFR-TKI erlotinib (ENCORE 401). NCI and Syndax are collaborating on the development of entinostat under a Cooperative Research and Development Agreement aimed at improving survival in advanced, hard-to-treat cancers.
Entinostat, Syndax’s lead product candidate, has been studied in more than 800 cancer patients where objective tumor responses have been observed in both solid and hematologic malignancies. Entinostat’s established safety and efficacy profile as both a single agent and in combination with a number of commercially available targeted therapies differentiates it from other histone deacetylase inhibitors (HDACi). Having demonstrated promising clinical results inbreast and lung cancer, entinostat is moving toward pivotal clinical testing. It is an oral, novel inhibitor of class I histone deacetylases, key enzymes that alter the structure of chromatin to control gene expression. This aberrant gene expression can result in reversible, epigeneticallybased drug tolerance. Designed to selectively target the HDAC isoforms most relevant to the biology of tumors, entinostat can normalize dysregulated gene expression in cancer cells, thereby restoring sensitivity to targeted therapy. Entinostat is the first HDACi with positive results in a randomized Phase 2 study in breast cancer and is the only HDACi in late-stage development for this indication.