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Corvus Pharmaceuticals closer to submitting Investigational New Drug application for CPI-818

Corvus Pharmaceuticals’s study of its investigational small molecule T-cell signaling pathway inhibitorresults, 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.

Corvus said in the announcement that it plans to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in early 2019, based on these data. Cervis looks to take CPI-818 to 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.

Richard A. Miller, president and CEO of Corvus, also an oncologist and co-founder, said that the experience developing ibrutinib, a drug used to treat B-cell lymphomas that is an inhibitor of BTK, which is homologous to ITK involved in T-cell receptor signaling, gave Corvus an important advantage in generating CPI-818, a highly selective inhibitor of ITK. He said. “Similar to the experience with ibrutinib, we initially tested CPI-818 in dogs with naturally occurring lymphomas. We are encouraged by these results, which suggest the importance of ITK inhibition on T-cells and immune function. We believe that CPI-818 has the potential to enhance immune response in a range of cancer types beyond T-cell lymphomas, providing additional development opportunities for this program.”

Data from in vitro studies of CPI-818, also presented at the meeting, have demonstrated that Cytotoxicity against several types of human and mouse T-cell lymphomas at concentrations that do not harm normal T-cells, and showed 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.

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