CPI-818 Data Highlights Potential for ITK Inhibition as a New Immunotherapy Approach for the Treatment of T Cell Lymphoma
Interim data from Phase 1/1b clinical trial of CPI-818, including new evidence supporting the recently implemented minimum absolute lymphocyte count (ALC) predictive biomarker
Data presented at the 10th Whistler Global Summit on Hematologic Malignancies
“T cell lymphoma is a challenging disease to treat and there is significant need for new approaches given the limited efficacy of current therapeutic options,” said
CPI-818 Phase 1/1b T Cell Lymphoma Data
CPI-818 is currently being studied in a Phase 1/1b clinical trial as a single agent therapy in patients with relapsed TCL. As of
Corvus has identified minimum absolute lymphocyte count (ALC) above 900 per cubic milliliter of blood as a biomarker associated with response to CPI-818. Interim data from the 200 mg cohort in the Phase 1/1b clinical trial indicate that this minimum ALC level is required for tumor response and disease control. As of
New interim data, as of
The swimmer and waterfall tumor plots for these patients, along with the data summarizing the ALC biomarker data, are included in Dr. Reneau’s presentation slides, which are available on the Publications and Presentations page of the Corvus website.
“The data from our Phase 1/1b trial of CPI-818 for T cell lymphoma continues to be strong, with durable and deep tumor responses observed to date,” said
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is CPI-818, an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies and is in a multicenter Phase 1/1b clinical trial in patients with several types of T cell lymphomas. The Company’s second clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor that is in an open-label Phase 1b/2 clinical trial. Its third clinical program, mupadolimab (CPI-006), is a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical and clinical studies. For more information, visit www.corvuspharma.com.
CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T cell kinase) in preclinical studies. It was designed to block malignant T cell growth and to 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. Recent clinical data in T cell lymphomas suggests that CPI-818 has the potential to control differentiation of T helper cells and enhance immune responses to tumors. Interference with ITK signaling also can modulate immune responses to various antigens. Optimal doses of CPI-818 have been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of Th2 related cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The immunologic effects of CPI-818 lead to what is known as Th1 skewing and is made possible by the high selectivity of CPI-818 for ITK. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with T cell lymphomas, solid tumors, and in patients with autoimmune and allergic diseases. The Company is conducting a Phase 1/1b trial in patients with refractory T cell lymphomas that was designed to select the optimal dose of CPI-818 and evaluate its safety, PK, target occupancy, immunologic effects, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, and identified a dose that maximally affects T helper cell differentiation.
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-818, ciforadenant and mupadolimab; the Company’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company Phase 1/1b clinical trial of CPI-818 and the Company’s planned Phase 3 registration clinical trial with CPI-818 for T cell lymphoma; the design of clinical trials, including the target number of patients to be enrolled and whether identifying certain biomarkers will help accelerate enrollment; and the timing of the availability and announcement of clinical data and certain other product development milestones. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Annual Report on Form 10-K for the year ended
Chief Financial Officer
Source: Corvus Pharmaceuticals, Inc.