BURLINGAME, Calif. — Corvus Pharmaceuticals, Inc (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for soquelitinib for the treatment of T-cell lymphoma. Soquelitinib, the Company’s lead ITK inhibitor candidate, is expected to advance into a Phase 3 registrational clinical trial in patients with relapsed peripheral T-cell lymphoma (PTCL) in the second quarter 2024.
“Peripheral T-cell lymphoma is an aggressive subset of non-Hodgkin’s lymphoma typically associated with a poor prognosis,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “For these patients, there is significant need for new therapies given that existing drugs provide limited efficacy and are associated with significant toxicity. There are no FDA approved agents for relapsed PTCL. The orphan drug designation is an important milestone in the development of soquelitinib that reinforces the unmet need for patients with T-cell lymphoma.”
FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.
About Soquelitinib
Soquelitinib (formerly known as c) 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 also 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 registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL.
About Corvus Pharmaceuticals
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. Corvus plans to initiate a Phase 3 registrational clinical trial for soquelitinib in patients with relapsed peripheral T-cell lymphoma. Its other clinical-stage candidates are being developed for a variety of cancer indications.
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Corvus Pharmaceuticals, Inc.
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