Pfizer, Merck KGaA, Syndax Sign Immuno-Oncology Pact
Merck KGaA, Pfizer, and Syndax Pharmaceuticals, Inc. have entered into a collaboration agreement to evaluate avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Syndax's entinostat, an investigational oral small molecule that targets immune regulatory cells (myeloid-derived suppressor cells and regulatory T-cells), in patients with heavily pre-treated, recurrent ovarian cancer.
Avelumab is currently under clinical investigation across a broad range of tumor types by the alliance between Merck KGaA and Pfizer. This is an exclusive agreement between the alliance and Syndax to study the combination of these two investigational agents in ovarian cancer. Syndax will be responsible for conducting the Phase Ib/II clinical trial in ovarian cancer. Financial terms were not disclosed.
Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to potentially enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity. In November 2014, Merck KGaA and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
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, ovarian cancer, melanoma, and triple-negative breast cancer (TNBC). 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 as a combination therapeutic in Phase Ib/II clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma and with Genentech, Inc. for TNBC, as well as in a Phase III clinical trial with the ECOG-ACRIN Cancer Research Group for advanced hormone receptor positive breast cancer, an indication for which entinostat was granted breakthrough therapy designation by the US Food and Drug Administration.