On December 9, 2019 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies with biomarker patient enrichment selection, reported that initial results from its Phase 1/1b trial of CPI-818, the Company’s ITK-inhibitor (Press release, Corvus Pharmaceuticals, DEC 9, 2019, View Source [SID1234552112]). The early clinical data from the study demonstrated specific target engagement by CPI-818. The results were presented in a poster at the American Society of Hematology (ASH) (Free ASH Whitepaper) 61st Annual Meeting 2019 in Orlando, Florida, taking place December 7-10, 2019.

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"We are excited to report the first clinical experience with CPI-818, our selective covalent ITK inhibitor designed to address T-cell lymphomas, a category of hematologic cancers with great need for novel therapeutic options," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "The results show that CPI-818 achieved specific and sustained target occupancy and we look forward to continuing the dose escalation portion of the study to identify an optimum dose. In addition to T-cell lymphomas, we believe CPI-818 may have applications in other immune mediated diseases. Overall, our team is now advancing three candidates in clinical trials for a wide range of cancers, and each of our programs remains on track with enrollment and progress towards next data milestones."

The CPI-818 Phase 1/1b study is currently enrolling patients with several types of advanced, refractory T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), angioimmunoblastic T-cell lymphoma (AITL), cutaneous T-cell lymphoma (CTCL) and other T-cell lymphomas. The study employs an adaptive, expansion cohort design to select the dose and evaluate the safety, pharmacokinetics (PK), target occupancy, immune-related biomarkers and efficacy of CPI-818. The initial phase of the trial is evaluating escalating doses in successive cohorts of patients in order to determine the optimum dose. A second phase will evaluate safety and tumor response to this optimum dose of CPI-818 in disease-specific patient cohorts that may be expanded based on early signs of efficacy. The study is enrolling patients at major medical centers in the United States, Australia and South Korea.

CPI-818 Phase 1/1b Results at ASH (Free ASH Whitepaper) 2019
The preclinical and early clinical data from the Phase 1/1b trial of CPI-818 was presented by Patrick Ng, PhD, Corvus Senior Scientist, in a poster session at the ASH (Free ASH Whitepaper) Annual Meeting. The key highlights from the poster, which is titled "Preliminary Clinical Data from a Phase 1 Trial with CPI-818, A Selective ITK Inhibitor that Preferentially Blocks the Growth of T Lymphoma Cells," include:

Seven patients have been enrolled in the first two dose cohorts in the initial phase of the trial, receiving a 100 mg or 200 mg oral dose of CPI-818 two times per day, with no dose limiting toxicities and no grade 3 or 4 adverse events observed.
The results from the pharmacokinetic and occupancy studies for the first seven patients have been in-line with expectations. The Company anticipates that a dose that achieves maximum target occupancy will be achieved in the next one or two dose cohorts.
CPI-818 has been shown to bind covalently to ITK at low nanomolar concentrations without reacting with other kinases.
In vitro studies demonstrated selective cytotoxicity to Sezary cells (malignant cells from patients with CTCL), while sparing normal T-cells, in three subjects not enrolled in the study.
Preclinical murine models of lymphoproliferative and autoimmune disease showed CPI-818 inhibited the development of lymph node and spleen enlargement by preventing proliferation of abnormal T-cells. Treatment with CPI-818 led to regression of lymphadenopathy and splenomegaly in animals with established disease.