Corvus Pharmaceuticals, Inc. announced data from a preclinical study of CPI-818, its investigational small molecule T-cell signaling pathway inhibitor. Study results indicated that orally-administered CPI-818 produced tumor regression in three of three companion dogs with spontaneous, naturally occurring T-cell lymphomas, without significant toxicity. Based on these data, Corvus plans to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in early 2019. The company plans to evaluate CPI-818 in a Phase 1/1b study in patients with several types of T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others. Data from in vitro studies of CPI-818, also presented at the meeting, have demonstrated: Cytotoxicity against several types of human and mouse T-cell lymphomas at concentrations that do not harm normal T-cells. Evidence of Th1 skewing in human and mouse lymphocytes, indicating that CPI-818 induced the differentiation of T-cells to cytotoxic (killer) T-cells, which is thought to be an important component of the immune system’s destruction of cancer cells. CPI-818 is a small molecule drug given orally that has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase). It was developed to possess dual properties: to block malignant T-cell growth and modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas – similar to the role of Bruton’s tyrosine kinase (BTK) in B-cells. BTK is now an established target for treating various B-cell lymphomas, and two BTK inhibitors, ibrutinib and aclarabrutinib, have been approved by the U.S. Food and Drug Administration for lymphoma indications. CPI-818 has been evaluated in preclinical efficacy and safety studies.