On July 25, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CB-1158 for the treatment of solid tumors (Press release, Calithera Biosciences, JUL 25, 2016, View Source [SID:1234514013]). CB-1158 is a first-in-class, orally available small molecule inhibitor of the enzyme arginase.

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"We are pleased to be advancing the first arginase inhibitor into clinical trials. Arginase is a novel target in metabolic immuno-oncology, and these studies will allow us to assess the safety, pharmacokinetics and pharmacodynamics of this exciting new agent," said Susan M. Molineaux, Ph.D., founder, Chief Executive Officer and President of Calithera Biosciences. "CB-1158 has demonstrated significant anti-tumor activity in preclinical models, and we look forward to reporting initial clinical results with this compound in 2017."

Arginase exerts its immunosuppressive effect by depleting the amino acid arginine in the tumor microenvironment and prevents activation and proliferation of the immune system’s cytotoxic T-cells and natural killer (NK) cells. Inhibition of arginase activity reverses this immunosuppressive block and restores T-cell function. 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 antibody.