Syndax Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing entinostat as a combination therapy in multiple cancer indications, announced today that it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the safety, tolerability and preliminary efficacy of Syndax's entinostat, an oral small molecule that targets immune regulatory cells (myeloid-derived suppressor cells (MDSCs) and regulatory T cells (Tregs)), in combination with Genentech's atezolizumab (MPDL3280A), a fully humanized monoclonal antibody targeting protein programmed cell death ligand 1 (PD-L1), in patients with triple-negative breast cancer. Triple-negative breast cancer is estimated to account for 10-20% of all diagnosed breast cancers and is characterized by a lack of expression of estrogen receptor (ER-), progesterone receptor (PR-) and HER2 (HER2-) on the breast cancer cells.
"Clinical development collaborations with industry leaders are an essential element of our strategy to realize the full potential of entinostat and position Syndax at the forefront of next-generation immuno-oncology therapy," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "This collaboration expands our emerging immuno-oncology program into an important new indication. We are looking forward to collaborating with Genentech to study atezolizumab and entinostat in a breast cancer population with few treatment options."
Syndax will be responsible for conducting the Phase 1b/2 clinical trial in triple-negative breast cancer and the agreement includes a provision where the parties may extend the collaboration to include a Phase 3 clinical trial as well as additional trials in new indications of mutual interest.
About Syndax Pharmaceuticals, Inc.
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. Entinostat is being evaluated in a Phase 1b/2 clinical trial for non-small cell lung cancer and melanoma and in a Phase 3 clinical trial for advanced breast cancer. For more information on Syndax please visit www.syndax.com.
Cautionary Note on Forward-Looking Statements from Syndax
This press release contains forward-looking statements. Forward-looking statements contained in this press release include, without limitation, statements regarding the potential to extend the collaboration into new indications and Syndax's expectations regarding the development of its immuno-oncology program. Words such as "may," "believe," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance and involve a number of unknown risks, assumptions, uncertainties and factors that are beyond Syndax's control. All forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Except as required by law, Syndax expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.
Investor and Media Relations:
Karen L. Bergman