Syndax Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, 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.

Syndax is a clinical-stage biopharmaceutical company developing entinostat as a combination therapy in multiple cancer indications with an initial focus on tumours that have shown sensitivity to immunotherapy, including lung cancer, melanoma and triple negative breast cancer.