On September 15, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that the first patient has been dosed in a Phase I clinical trial assessing the safety and efficacy of CB-1158, a first-in-class arginase inhibitor for the treatment of advanced solid tumors (Press release, Calithera Biosciences, SEP 15, 2016, View Source [SID:SID1234515171]). Arginase is an enzyme in myeloid-derived suppressor cells (MDSCs), which prevents T-cell and natural killer (NK) cell activation in tumors. Schedule your 30 min Free 1stOncology Demo! "Arginase, when released by MDSCs, plays an important role in the inhibition of T-cell and NK-cell activation and proliferation, preventing immune-mediated anti-tumor activity. For example, in many solid tumors, including lung, colorectal, esophageal, bladder, head and neck, and kidney cancer, arginase-expressing MDSCs accumulate, establishing an immunosuppressive microenvironment by blocking the ability of T-cells and NK-cells to kill cancer cells. We believe that inhibitors of arginase can promote an anti-tumor immune response and augment the activity of checkpoint inhibitors," said Susan M. Molineaux, Ph.D., founder, Chief Executive Officer and President of Calithera Biosciences. "We look forward to reporting initial clinical results with this compound in 2017."
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Arginase exerts its immunosuppressive effect by depleting the amino acid arginine in the tumor microenvironment and preventing activation and proliferation of the immune system’s cytotoxic T-cells and NK-cells. We believe that inhibitors of arginase activity promote an anti-tumor immune response by restoring arginine levels in the tumor and reversing this immunosuppressive metabolic checkpoint. The Phase I clinical trial will enroll patients with advanced solid tumors treated with CB-1158 as a monotherapy, as well as in combination with an anti-PD1 therapy.