FDA Fast Tracks Corvus' Soquelitinib for Refractory PTCL

Corvus Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to soquelitinib for treating adult patients with relapsed or refractory peripheral T cell lymphoma (PTCL) after at least two lines of systemic therapy. This designation underscores the significant unmet need for effective treatments for PTCL, a condition characterized by poor overall outcomes and the absence of FDA fully approved drugs based on randomized trials.

Dr. Richard A. Miller, co-founder, president, and CEO of Corvus, emphasized the importance of this designation, stating, "The current treatment options for these patients are limited in efficacy and come with significant toxicity. There is no FDA fully approved agent for this indication. The Fast Track Designation highlights the urgent need for better treatment options. We are on track to begin patient enrollment in our Phase 3 clinical trial for PTCL in the third quarter of 2024."

The Fast Track program aims to facilitate the development and expedite the review of new drugs that treat serious or life-threatening conditions and have the potential to address unmet medical needs. This designation accelerates the development and review process by increasing communication between the FDA and drug developers and allowing the FDA to review portions of a drug application on a rolling basis. In addition to the Fast Track Designation, soquelitinib has also received FDA Orphan Drug Designation for treating T cell lymphoma. This status provides several benefits, including assistance in the drug development process, tax credits for clinical costs, exemptions from specific FDA fees, and seven years of post-approval marketing exclusivity.

Corvus Pharmaceuticals is at the forefront of developing ITK inhibition as a new approach to immunotherapy for a range of cancers and immune diseases. Their lead product candidate, soquelitinib, is an investigational, oral, small molecule drug designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase). This enzyme is mainly expressed in T cells and plays a crucial role in T cell and natural killer (NK) cell immune function. Early results from a Phase 1/1b clinical trial involving patients with refractory T cell lymphomas showed promising tumor responses in very advanced and difficult-to-treat T cell malignancies. These positive outcomes have paved the way for the initiation of a registrational Phase 3 clinical trial in patients with relapsed PTCL.

Moreover, soquelitinib is also being studied in a randomized placebo-controlled Phase 1 clinical trial for patients with atopic dermatitis. The drug's immunologic effects lead to Th1 skewing and inhibition of Th2 and Th17 cells. Research suggests that soquelitinib has the potential to control the differentiation of normal T helper cells and enhance immune responses to tumors by increasing the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. It has also been shown to prevent T cell exhaustion, a significant limitation of current immunotherapy and CAR-T therapies.

Soquelitinib’s ability to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of Th2 and Th17 cells and their secreted cytokines is noteworthy. Th1 T cells are essential for immunity to tumors, viral infections, and other infectious diseases, whereas Th2 and Th17 helper T cells are implicated in the pathogenesis of many autoimmune and allergic diseases. Corvus believes that inhibiting specific molecular targets in T cells could be therapeutically beneficial for patients with cancers, including solid tumors, and those with autoimmune and allergic diseases.

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