Syndax Pharmaceuticals Receives $26.6 Million for Final Stage Push With Cancer Drug

Syndax Pharmaceuticals Inc., which is developing epigenetic therapies for treatment-resistant cancers, recently announced it has secured a $26.6 million Series B financing. Participating investors included Domain Associates, MPM Capital, Forward Ventures, and RusnanoMedInvest (RMI).

Syndax plans to use the proceeds to continue advancement of its late-stage pipeline of epigenetic-based combination therapies for treatment-resistant cancers, including activities in preparation for an NDA-enabling Phase III study of entinostat in metastatic breast cancer. The study is currently being developed by the ECOG-ACRIN Cancer Research Group, which would conduct the study under the sponsorship of the Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI).

“Entinostat represents the most advanced clinical program of an epigenetic therapy in solid tumors,” said Arlene M. Morris, Syndax’s CEO. “We have a unique opportunity to help a patient population in which safe and effective treatments capable of extending survival are needed desperately. The Series B financing enables us to continue to advance entinostat toward registration, where we believe the opportunity in breast cancer and lung cancer alone exceeds $2 billion.”

In the completed Phase II ENCORE 301 study, entinostat was shown to extend both progression-free survival and overall survival when added to exemestane in postmenopausal women with estrogen receptor-positive (ER+) metastatic breast cancer whose cancer had progressed after treatment with a nonsteroidal aromatase inhibitor. In addition, a potential pharmacodynamic biomarker identified in a subset of patients with ER+ tumors was associated with greater progression-free survival.

Entinostat, Syndax’s lead product candidate, has been studied in more than 800 cancer patients in which 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 in breast 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, epigenetically-based 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 II study in breast cancer and is the only HDACi in late-stage development for this indication.

Syndax is focused on employing epigenetic strategies to overcome the problem of resistance in oncology care in solid tumors. For more information, visit www.syndax.com.