Belinostat

Soquelitinib is a potential first-in-class ITK inhibitor with broad potential in cancer and immune diseases There are currently no fully approved agents for the treatment of relapsed PTCL and soquelitinib has been granted Orphan Drug Designation and Fast Track Designation by the FDA Sept. 10, 2024 -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a registrational Phase 3 clinical trial of soquelitinib for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). The clinical trial is a randomized, controlled study that will evaluate the efficacy and safety of soquelitinib compared to standard of care chemotherapy. "The initiation of the soquelitinib Phase 3 trial for relapsed PTCL is an important milestone for Corvus and for patients suffering with this disease," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Soquelitinib has a unique mechanism of action based on selective ITK inhibition, which we believe has potential for the treatment of T cell lymphomas, as well as for solid tumors and a broad range of immune diseases.” The clinical trial (NCT06561048) is designed to enroll approximately 150 patients with relapsed/refractory PTCL who have failed one to three prior lines of therapy. Patients will be randomized in a 1:1 ratio to receive either 200mg dose of soquelitinib two-times a day or standard of care chemotherapy with either belinostat or pralatrexate. The primary endpoint of the clinical trial is progression-free survival and secondary endpoints include overall survival, objective response rate, and duration of response. The trial is expected to enroll patients at approximately 40 sites in the United States, Canada, Australia and South Korea. "We are excited to participate in this Phase 3 trial evaluating a new therapy for patients with relapsed/refractory PTCL," said Swaminathan P. Iyer, M.D., principal investigator of the study and Professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center. "In earlier stage trials, soquelitinib has been well-tolerated and has demonstrated durable anti-tumor activity in patients with very advanced disease. Soquelitinib’s novel mechanism of action results in enhancement of the host anti-tumor response. In general, chemotherapy drugs have not produced lasting remissions and are sometimes associated with significant toxicity. There has been a scarcity of new ideas for the treatment of PTCL and we are eager to see if soquelitinib can offer these patients a more effective and safer treatment." Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com. 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 Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. Initial therapy for these diseases is typically combination chemotherapy, however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the 3 to 4 month range and overall median survival of 6 to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials.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. Soquelitinib (formerly 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. 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 has initiated a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also now being investigated in a randomized placebo controlled phase 1 clinical trial in patients with atopic dermatitis. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and inhibition of Th2 and Th17 cells. 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 also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Soquelitinib has 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. The content above comes from the network. if any infringement, please contact us to modify.