Syndax Pharmaceuticals said today it will partner with Genentech, a member of the Roche Group, in a combination cancer immunotherapy clinical trial. The value of the collaboration was not disclosed.

The Phase Ib/II trial will be designed to assess the safety, tolerability, and preliminary efficacy of Syndax' entinostat in combination with Genentech's atezolizumab (MPDL3280A) in patients with triple-negative breast cancer. Syndax has agreed to conduct the trial.

“This collaboration expands our emerging immuno-oncology program into an important new indication,” Syndax CEO Briggs W. Morrison, M.D., said in a statement. “We are looking forward to collaborating with Genentech to study atezolizumab and entinostat in a breast cancer population with few treatment options.”

The companies may also extend their collaboration to include a Phase III clinical trial as well as additional trials in new indications of mutual interest, Syndax added.

Entinostat is an oral small molecule that targets immune regulatory cells, both myeloid-derived suppressor cells (MDSCs) and regulatory T cells (Tregs). A targeted, epigenetic immunomodulator (EMOD), entinostat has demonstrated selective inhibitory activity against Class I histone deacetylases (HDACs), according to Syndax.

Syndax is developing entinostat as a component of a combination therapy in multiple cancer indications, with an initial focus on tumors that have shown sensitivity to immunotherapy.

Entinostat is the subject of the Phase Ib/II ENCORE 601 trial in patients with non-small cell lung cancer and melanoma, in combination with Merck & Co.’s marketed PD-1 checkpoint inhibitor Keytruda® (pembrolizumab); as well as a Phase III pivotal trial with ECOG-ACRIN Cancer Research Group assessing the combination of entinostat and Pfizer’s aromatase inhibitor Aromasin (exemestane) in patients with advanced breast cancer.

Atezolizumab is a fully humanized monoclonal antibody targeting protein programmed cell death ligand 1 (PD-L1), in patients with triple-negative breast cancer.

On August 16, Genentech trumpeted positive results for atezolizumab from the pivotal Phase II BIRCH study showing that the compound met its primary endpoint by shrinking tumors in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1. The amount of PD-L1 expressed by a person's cancer correlated with their response to atezolizumab, Genentech said.








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