On October 19, 2019 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 first patient has been treated in the Phase 1 cohort of INCB01158 (also known as CB-1158) in combination with Keytruda (pembrolizumab), an anti-PD1 immune checkpoint inhibitor (Press release, Calithera Biosciences, OCT 19, 2017, View Source [SID1234535255]). INCB01158 is a potent, selective, oral inhibitor of arginase being developed pursuant to a global collaboration and license agreement with Incyte Corporation.
"Arginase is involved in the metabolism of a key amino acid that is required for optimal anti-cancer immune function," said Susan M. Molineaux, Ph.D., founder, Chief Executive Officer and President of Calithera Biosciences. "In combination with an anti-PD1 therapy, an inhibitor of arginase may reduce immunosuppression caused by myeloid cells and broaden the reach of immuno-oncology therapies."
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The Phase 1 trial (NCT02903914) is designed to evaluate the safety and recommended Phase 2 dose of INCB01158 as a monotherapy, and in combination with immune checkpoint therapy. The trial was initiated in September 2016 and is designed to enroll monotherapy expansion cohorts of patients with advanced non-small cell lung cancer, colorectal cancer and other solid tumors. The recommended Phase 2 monotherapy dose has been selected, and several cohorts of additional tumor types have been added to the trial design. Expansion cohorts of INCB01158 dosed in combination with Keytruda are expected to enroll patients diagnosed with non-small cell lung cancer, melanoma, urothelial cell carcinoma, colorectal cancer, gastroesophageal cancer, squamous cell head and neck cancer and mesothelioma