Corvus Pharmaceuticals Confirms Planned Initiation of Soquelitinib (CPI-818) Phase 3 Registrational Clinical Trial in Peripheral T Cell Lymphoma Following Meeting with FDA
Plans to initiate soquelitinib potentially registrational Phase 3 clinical trial in Q1 2024
Company to host conference call and webcast tomorrow at
“We are pleased with the outcome of our End-of-Phase/Pre-Phase 3 meeting with FDA, allowing us to advance ITK inhibition with soquelitinib into a potentially registrational clinical trial for patients with relapsed peripheral T cell lymphoma,” said
The soquelitinib Phase 3 potentially registrational clinical trial is designed to enroll a total of 150 patients with relapsed PTCL that have received three or fewer prior therapies. Patients will be randomized 1:1 to soquelitinib 200 mg two-times a day or standard of care chemotherapy. The primary endpoint will be progression-free survival. Secondary endpoints will include objective response rate and overall survival. The Company is recruiting
Data highlighting the potential of selective inhibition of ITK to potentially enhance anti-tumor immune response to hematologic and solid tumors and provide a novel potential approach to cancer immunotherapy were recently published online as a preprint at bioRxiv.org. In addition, data demonstrating soquelitinib’s anti-tumor activity in patients with T cell lymphoma (TCL) and its therapeutic potential in Th2 and Th17-mediated autoimmune and allergic diseases was presented in a poster at the 64th
Conference Call Details
Corvus will host a conference call and webcast tomorrow, Thursday, September 7, 2023, at 8:30 a.m. ET (
About Corvus Pharmaceuticals
Soquelitinib (CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and is made possible by the high selectivity of soquelitinib for ITK. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Optimal doses of soquelitinib 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 their secreted 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 Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company plans to initiate a potentially registrational Phase 3 clinical trial of soquelitinib in patients with relapsed peripheral T cell lymphoma (PTCL).
About Peripheral T Cell Lymphoma
Peripheral T cell lymphoma (PTCL) is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of
PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype.
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib and ciforadenant; the potential use of soquelitinib to treat a variety of solid tumors and hematological cancers as well as autoimmune/allergic diseases; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates through and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1/1b clinical trial of soquelitinib and its potentially registrational Phase 3 clinical trial for soquelitinib; the timing and its ability to launch clinical trials including the potentially registrational Phase 3 clinical trial for soquelitinib; and clinical trial designs and plans. 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 Quarterly Report on Form 10-Q for the three months ended
Chief Financial Officer
Source: Corvus Pharmaceuticals, Inc.