FDA Grants Orphan Status to Soquelitinib for T Cell Lymphoma

Corvus Pharmaceuticals, a biopharmaceutical firm in the clinical stage, has received Orphan Drug Designation from the FDA for its lead candidate soquelitinib to combat T cell lymphoma. Scheduled to enter Phase 3 trials for relapsed peripheral T cell lymphoma (PTCL) in the second half of 2024, soquelitinib is an ITK inhibitor designed to target a protein expressed in T cells, which is crucial for their immune function.

According to Richard A. Miller, the president and CEO of Corvus, PTCL is a severe form of non-Hodgkin’s lymphoma with a grim prognosis. He emphasizes the necessity for new treatments due to the limited effectiveness and high toxicity of current medications. The FDA's orphan drug status is a significant step for soquelitinib, offering benefits such as development assistance, tax credits, fee exemptions, and a seven-year marketing exclusivity post-approval.

Soquelitinib, previously CPI-818, is an oral drug that selectively inhibits ITK, leading to Th1 skewing due to its high selectivity. It has the potential to regulate the differentiation of T helper cells and enhance immune responses to tumors by increasing cytotoxic killer T cells and cytokines that inhibit cancer cell survival. It also prevents T cell exhaustion, a limitation of current immunotherapies. The drug has shown to affect T cell differentiation, induce Th1 helper cells, and block the development of Th2 and Th17 cells and their cytokines. Th1 T cells are vital for immunity against tumors and infections, while Th2 and Th17 are linked to autoimmune and allergic diseases.

Corvus Pharmaceuticals is pioneering ITK inhibition for immunotherapy in cancer and immune diseases. Soquelitinib's interim Phase 1/1b results in refractory T cell lymphoma patients have shown tumor responses, prompting the initiation of a Phase 3 trial for relapsed PTCL. The company is committed to developing treatments for a range of cancers and immune disorders, with soquelitinib at the forefront of its clinical-stage pipeline.